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PharmaRelations does more than hundred recruitments per year on behalf our clients, we have assembled a small selection of previous recruitment assignments  to display the width of our expertise. We focus solely on Life Science and do not recruit for other industries.

2021

2021-11-08

PharmaRelations AB,Filial DK

Produktspecialist, operationsudstyr

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Produktspecialist, operationsudstyr
PharmaRelations er en markedsledende Nordisk rekrutterings- og konsulent virksomhed specialiseret indenfor Life Science industrien. Vi har partnerskaber med nogle af de mest top innovative virksomheder fra Life Science industrien. Vi tilfører vores kunder værdi i form af kandidater til enten fastansættelser eller midlertidige specialister/ledere til outsourcede opgaver af kortere eller længere varighed. For en af vores kunder søger vi en dygtig produktspecialist med erfaring fra operationsspecialet (operationssygeplejerske) eller erfaring fra salg af operationsudstyr. Det ledige distrikt ligger på Sjælland. Virksomheden sælger egenproducerede engangsprodukter såvel som videresælger kvalitetsprodukter indenfor det operative speciale såvel som andre specialer. Du vil få en nøglerolle med at opbygge relationer med dine samarbejdspartnere på hospitalerne og udbygge virksomhedens stilling på markedet med salg af engangsoperationsudstyr. Det er ikke en betingelse, at du har salgserfaring, men vigtigt at du har flair for at servicere kunderne samt har en forretningsmæssig forståelse. Dine opgaver vil være: Etablere kontakt og udbygge relationer med operationsafdelingernes personale og indkøberne på hospitalerne Servicere kunderne så de får en god kundeoplevelse Vækste salget og øge markedsandelene for produkterne Din baggrund: Du har erfaring fra operationsgang, enten almen-, ortopæd- eller ØNH kirurgisk afdeling Det vil være en fordel med erfaring fra salg af produkter, men det er ikke en betingelse Dig selv: Du er målrettet og resultatorienteret Din tilgang er struktureret og du kan godt li' et arbejdsmiljø, hvor vi har travlt, men også husker, at være gode kollegaer for hinanden Du er klart en teamplayer og glad for at samarbejde, om de ting hvor vi kan hjælpe hinanden Du har en god selvtillid og kan li' at undervise og være i dialog med kunderne Din bopæl vil være det daglige udgangspunkt for dit arbejde, hvorfor du skal have plads til en hjemmearbejdsplads. Din arbejdsgiver afholder udgifterne til kontorudstyr. Du tilbydes en attraktiv arbejdsplads hos et firma med stor vækst og fin ordretilgang. Løn efter kvalifikationer, firmabil og andre personalegoder, bl.a. tilskud til fitness eller anden sport samt sundhedsforsikring. Du har kørekort til personbil. For uddybende informationer er du velkommen til at kontakte recruitment manager Lise Sønnersgaard, PharmaRelations på tlf 60981303 eller via mail lise.sonnersgaard@pharmarelations.dk Du er også meget velkommen til at uploade din ansøgning og CV direkte nedenfor her. Aht. GDPR kan vi desværre ikke modtage CV'er via e-mail. Interviews foregår løbende, så upload din ansøgning og CV hurtigst muligt.

2021-10-20

PharmaRelations AB,Filial DK

Team Lead QA/QP PharmaRelations

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Team Lead QA/QP PharmaRelations
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. Head of Quality Assurance med bred erfaring – gerne fra både Med. Tech. og Pharma Til en nyoprettet stilling søger PharmaRelations en teamleder til Quality Assurance, som har lyst til at lede og udbygge vores afdeling. Vi løser mange ad-hoc og projektbaserede opgaver for vores kunder fra Pharma- og Med. Tech. industrien. Vi oplever stor efterspørgsel på vores services, så derfor er det vigtigt, at du er indstillet på selv at deltage i opgaverne for vores kunder og er vant til ”hands on”. Du skal have erfaring med eller lyst til ledelse af et team og vil få en varieret dagligdag, hvor ingen dage er ens. Dine opgaver vil afspejles i behov, som du i nogle tilfælde selv er med til at afdække i dialog med vores kunder. Det kan eksempelvis være auditering, behov for at dække en RP eller QP rolle, udarbejde nye processer mmm. Hvilke faglige og personlige egenskaber kræves til jobbet? I denne rolle vil du blive udfordret på din faglighed, kommunikationsevner og interpersonelle egenskaber. Derfor bliver det vigtigt, at du, på den ene side, har et solidt fagligt ståsted, og at du samtidigt finder mennesker og samarbejde dem imellem, interessant. En stor grad af nysgerrighed, engagement og ” lyttende ører”, vil være med til at skabe dit succesfulde team og stærke resultater hos virksomhederne. At have modet til at opbygge en afdeling, og samtidigt levere hos vores samarbejdspartner, er ikke nemt; så du skal kunne prioritere og arbejde struktureret og målrettet, med en god portion humor. Lidt om vores afdeling: I skrivende stund er vi en håndfuld dedikerede og positive medarbejdere i det danske team, der fagligt spænder vidt indenfor QA og RA – indenfor flere klassifikationer af produkter. Vi har et tæt samarbejde med vores nordiske kolleger primært i Stockholm, der besidder en bred vifte af kompetencer, så vi er klar til at løfte i flok, når der indløber opgaver, som er omfattende. Lyder det interessant? Du skal være velkommen til at sende din ansøgning og CV via hjemmesiden www.pharmarelations.dk Ansøgninger behandles løbende. For mere information kontakt den ansvarlige hos PharmaRelations, Lise Sønnersgaard, enten på mail lise.sonnersgaard@pharmarelations.dk eller telefon 60981303. Ansøgninger behandles løbende, så send din ansøgning allerede i dag. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-10-13

Zoetis

Nordic QA/RA manager

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Nordic QA/RA manager
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. We are currently partnering with Zoetis, - an innovative animal health company. They are looking to recruit a Nordic QA/RA manager to join their Nordic team in Copenhagen, Denmark. The position is office based, full-time and travel must be excepted. This position reports to the Head of QA/RA Nordics. As the Nordic QA/RA Manager, you will be responsible for a diverse range of tasks within QA and RA and be the go-to-person within the above-mentioned disciplines. You have some experience with QA related tasks such as CAPA, variations, reviews and the QMS system and are happy to use your RA knowledge, give input to the commercial side of the business and work in close collaboration with Authorities and attend audits. Hence one will have a supportive attitude and role towards the Nordic business, and proactively participate in assignments related to quality and regulatory affairs. Key responsibilities include: Support the Nordic organization within QA/RA Ensure external and internal communication with suppliers, Authorities, and stakeholders Maintain and ensure compliance level in QMS and other relevant systems Act as the SME for QA/RA Ensure trainings and workshops when needed Responsible for GDP Requirements: Preferable a bachelor or Master degree within Pharmacy, Veterinary medicine or related Industrial knowledge from healthcare or related Previous experience with QA and preferable RA (3 years) Stakeholder management skills: Communication, relationship building and coaching Positive with a can-do attitude Proactive, pragmatic, and entrepreneurial mindset Structured Why? Zoetis has great development possibilities and is an international company on a growth path. You will have an opportunity to broaden your capabilities, take part in a dynamic and agile company, where your effort and attitude is of essence. How? For further information do reach out to Head of recruitment Ida Wenger- Parving on +45 2633 4301 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-10-12

Nomeco A/S

QA Validation Manager

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QA Validation Manager
QA Validation Manager – med ansvar for validering i Nomeco Har du lyst og evner til at bære det overordnede ansvar for udvikling og implementering af QA- og valideringsstrategier for Nomeco, som er den førende lægemiddelgrossist for apoteker og hospitaler i Danmark? Din opgave bliver at sikre, at Nomecos IT-systemer, udstyr samt lokaler lever op til den valideringsstrategi og kvalitet, som du er med til at formulere og implementere i politikker, SOP og templates. Vores QA Validation Manager bliver en del af Q-ledergruppen i Nomeco med reference til Direktør for HR, Kvalitet samt Teknisk afd. Dine opgaver og ansvar: Sætte de overordnede rammer for Nomecos validerings strategi for IT-systemer, -udstyr samt lokaler Ansvarlig for valideringspolitikker, SOP’er samt templates. Quality oversight af validerings status Ejer af VMP-processerne Udvikling af valideringskoncept, med fokus på risikobaseret validering Ansvarlig for at implementering af kunde og myndighedskrag indenfor validering QA reviewer samt godkender af validerings dokumentation QA godkender på IT relaterede changes Sparringspartner for organisationen Undervisning i validering samt changes Deltage som SME ved audit af kontrakttagere Deltage ved både kunde- samt myndighedsaudit Stor kontaktflade til en meget bred vifte af pharmaproducenter Kvalifikationer: Praktisk erfaring fra QA-rolle indenfor den farmaceutiske industri (GMP / GDP) Praktisk erfaring med review og godkendelse af valideringer (erfaring med IT-validering er er stort plus) Har et grundigt kendskab til myndighedskrav til Kvalificering og Validering. E.g.: EU GDP, EU GMP Annex 15, EU GMP Annex 11 og GAMP 5 Praktisk erfaring med risikovurderinger (FMEA), ændringssager (CR) og afvigelser (NC/VNC) Praktisk erfaring med rootcause-analyser Erfaring med optimering samt implementering af forretningsprocesser Er struktureret og grundig, og leverer høj kvalitet til tiden Er udadvendt og selvstændig Er pragmatisk når situationen tillader det … men står også gerne fast, når der er behov for det Personlige kvalifikationer: Gode formuleringsevner - flydende i engelsk og dansk i skrift og tale Stærk kommunikator og drives af at udvikle organisationens kompetencer indenfor feltet Formentlig Ingeniør eller IT-uddannet, eller har erfaring med ovennævnte arbejdsopgaver fra et lignende job Er en åben og positiv holdspiller, der arbejder selvstændigt, har en systematisk og metodisk arbejdsform og – ikke mindst – en pragmatisk tilgang til problemløsning. Er udadvendt og serviceminded Nomeco tilbyder Et udfordrende og selvstændigt job i en virksomhed, hvor udvikling, vækst og kvalitet er nøgleord. Du vil – i et samarbejde med kolleger med forskellige baggrunde og et bredt erfaringsgrundlag – få mulighed for at sætte dit personlige præg på Nomecos udvikling samt standard inden for kvalitets-området. Det hele foregår i et kompetent, uhøjtideligt og travlt arbejdsmiljø med stor mulighed for faglig og personlig udvikling. Delt arbejdsadresse mellem Idunsvej 3, Køge og Borgmester Christiansens Gade 40, 1790 Kbh V. Nomeco har i slutningen af 2019 færdiggjort opførelsen af Nordeuropas største lægemiddellager. Lageret ligger ved Køge og er Nomecos nye topmoderne hovedkvarter for alle virksomhedens aktiviteter rettet mod lægemiddelindustrien. Lageret er med til at sikre, at vi kan imødekomme de stadigt stigende krav til kvalitet, herunder GDP/GMP krav, Annex 11 og serilisering / FMD. På lageret er den nyeste plukteknologi taget i anvendelse – herunder et stort højlager, der betjenes af automatiske kraner. Alle disse tiltag udgør tilsammen fundament, hvorpå vi kan tilbyde Nordens mest effektive og højtudviklede pre-wholesale-service til lægemiddelindustrien. Er din interesse vakt? Så send din ansøgning og CV via nedenstående link allerede i dag. Ansøgninger behandles løbende. Har du spørgsmål til stillingen er du velkommen til at kontakte Lise Sønnersgaard hos PharmaRelations, enten på tlf. 60981303 eller på mail lise.sonnersgaard@pharmarelations.dk. Vi glæder os til at høre fra dig.

2021-10-11

Head of RA and Subject Matter Expert

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Head of RA and Subject Matter Expert
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. Head of RA og Subject Matter Expert hos PharmaRelations Danmark Er du Subject Matter Expert (SME) indenfor det regulatoriske område? Og går du med tanker om mere ansvar, måske ledelse, så læs videre…. Hos PharmaRelations Danmark har vi stor succes med at levere løsninger inden for det regulatoriske område. Vi ser en stor efterspørgsel fra både store og mindre farmaceutiske og medical device virksomheder, hvilket er årsagen til, at vi har brug for at have dig med på denne rejse. Vi har brug for en kollega, som har lyst til at påvirke og præge det regulatoriske landskab ude hos de mange virksomheder, som efterspørger vores assistance og ekspertise. At tage rollen som Subject Matter Expert kræver en bred erfaring fra det regulatoriske felt og en stor grad af lyst, samt forståelse for virksomheders forskellige behov og RA udfordringer. At kunne sætte sig selv i spil og stille sin ekspertviden til rådighed i forskellige kontekster, er noget du sætter en ære i og driver dig. Du finder stor glæde i en mangfoldig berøringsflade, hvor arbejdet på nordisk plan inspirerer, og din proaktive deltagelse i ”best practice” grupper, ses som yderst meningsfuldt. Rollen indebærer intet direkte salgsansvar og dit fokus er at opbygge et regulatorisk team, som i samarbejde med dig kan implementere, og drive ad hoc løsninger, samt RA projekter hos en bred vifte af farmaceutiske og medical device organisationer. Du må derfor gerne have noget erfaring med både strategisk, taktisk og operationelle aktiviteter indenfor RA. Hvem er du? I denne rolle vil du blive udfordret på din faglighed, kommunikationsevner og interpersonelle egenskaber. Derfor bliver det vigtigt, at du, på den ene side, har et solidt fagligt ståsted, og at du samtidigt finder mennesker og samarbejde dem imellem, interessant. En stor grad af nysgerrighed, engagement og ” lyttende ører”, vil være med til at skabe dit succesfulde team og stærke resultater hos virksomhederne. At have modet til at opbygge en afdeling, og samtidigt levere hos vores samarbejdspartnere, er ikke nemt; så du skal kunne prioritere og arbejde struktureret og målrettet, med en god portion humor. Lidt om vores afdeling: I skrivende stund er vi en håndfuld dedikerede og positive medarbejdere i det danske team, der fagligt spænder vidt indenfor QA og RA – indenfor flere klassifikationer af produkter. Vi har et tæt samarbejde med vores nordiske kolleger primært i Stockholm, der besidder en bred vifte af kompetencer, så vi er klar til at løfte i flok, når der indløber opgaver, som er omfattende. Lyder det interessant? Du skal være velkommen til at sende din ansøgning og CV via hjemmesiden www.pharmarelations.dk Ansøgninger behandles løbende. For mere information kontakt den ansvarlige hos PharmaRelations, Ida Wenger-Parving på ida.parving@pharmarelations.dk eller telefon +45 2633 4301 Ansøg stillingen her: www.pharmarelations.dk At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-10-06

PharmaRelations ApS

Country Quality Head and Responsible Person

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Country Quality Head and Responsible Person
For vores kunde søger vi en Country Quality Head and Responsible Person. Stillingen Du vil blive del af udviklingen af et kvalitetskontrolsystem for at sikre pålidelige, værdiskabende og kompatible produkter, under vedligeholdelse af eksisterende produkter og ny produktudvikling. Du kan se frem til at blive en del af et udfordrende og udviklende miljø med dedikerede kolleger i QA/QC-afdelingen i en international virksomhed. Profil Dette er en stilling som QA ansvarlig indenfor kvalitetskontrol og GxP Management. Du får en fantastisk mulighed for at have ansvaret for at definere, implementere og vedligeholde lokale kvalitets system. Materialeteststyring af alle materialer (inkl. QC) QC laboratorietests, herunder frigivelsetest Håndtering af reference prøver Styring og test af stabilitetsprogram Validering og vedligeholdelse af QC-metoden Sørge for at afvigelser og OOS (Out of Specifikation) rapporteres og undersøges CAPA Sørge for at analyseudstyret lever op til gældende krav og vedligeholdes Overvågning af metodeoverførsler til og fra udvikling og produktion Laboratorie compliance Ansvarlig for monitoring af data for præstation af kvalitetskontrol og frigivelse Supportere frigivelse af batch og håndtering af reklamationssager Supportere udvikling af kvalitetsmål og mål for QC som en del af organisationens strategiske plan. Solid QA Erfaring fra reguleret produktion / industrielt miljø Du har en kandidatgrad i Pharma., biokemi, kemi eller lignende uddannelse/kvalifikationer. Din historik viser solid erfaring inden for kvalitetssikring af kvalitetskontrol og QC laboratorieledelse, fremstilling af produkter og designkontrol, og du mestrer alle discipliner relateret til QA. Du trives i en rolle, hvor du håndterer operationelle opgaver og leder mindre projekter i et miljø i forandring. Andre kvalifikationer: Mindst 5 års relateret erfaring. Erfaring med QC-laboratorium og forståelse af princippet Quality Directive QGQD-003023. God forståelse af regulatoriske standarder/ISO 9001. Erfaring med datapræstationrapportering til daglig gennemgang af drift/kvalitetsstyring. Erfaring med designstyringsprocessen/kvalitetsstyringssystemet. God forståelse for Quality Risk Management. Stærke mundtlige og skriftlige kommunikationsfærdigheder og evnen til at arbejde selvstændigt. Læser, skriver og taler dansk og engelsk på højt niveau. Stærke it-færdigheder som Excel, Outlook, Powerpoint og Word. Erfaring med LIMS er et plus. Ansøgning For mere information, kontakt Louise Brinking, Head of Medical interim Denmark hos PharmaRelations; +45 5376 9570 eller Louise.brinking@pharmarelations.dk. Vi vil evaluere ansøgninger løbende. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, colour, ancestry, national origin, ethnic group identification or age. Religion, political views, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-10-05

Paion

Nordic Sales Manager

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Nordic Sales Manager
PAION was formed in 2000 in Aachen. Since its inception, the founders, Mariola Söhngen, MD and Wolfgang Söhngen, MD focused on the clinical development of CNS compounds. Today PAIONs headquarter is placed in Aachen, Germany. It is a publicly listed specialty pharmaceutical company with innovative drugs to be used in hospital-based sedation, anesthesia and critical care services. Paion is now preparing market introduction in the Nordic region by employing a Nordic Sales Manager. Are you an experienced sales manager, looking for a rewarding, challenging and exciting opportunity to build and set the direction for the Nordic Sales Team? Then this job as Nordic Sales Manager might be just what you are looking for. As Nordic Sales Manager you manage the teams in the Nordics. Your focus is to lead and develop a high-performance sales team to achieve profitable growth for Paion’s products. Your goal is to meet the yearly sales and KPI targets and expected growth in a sustainable and commercially viable way. You are a people leader with a clear business acumen, you lead by example. You are highly dedicated to the tasks and your people feel an open door as well as a leader always ready to listen and coach your team to enable and exceed their potential. Your tasks and responsibilities: Build and set the direction for the Nordic KAM team, by attract, recruit, onboard, develop, motivate, and manage a robust and high performing team Build the Nordic Sales model based on Key Account Management, Account plans, objective setting Present sales, revenues and forecasts to Regional Management Ensure understanding and adherence to local laws, compliance rules and regulations and compliant business conduct of the KAM Build sustainable and successful customer relationship Effectively identify and monitor local market conditions Your profile: A profound and in depth understanding of the pharma environment with multiple stakeholder experience in the hospital environment in the Nordic countries – a detailed knowledge of the Swedish market access will be preferred Min. 5 years experience as 1stline manager Strong experience in product launches including implementation of digital communications channels Experience in building and driving high performance KAM teams with proven sales success Excellent planning and organisation, financial management, operational capability and business acumen Why? Paion offers an exciting position in a very innovative company. The products will fulfil unmet customer needs on the market and has a great potential. For you personally the offer is a great deal of creative freedom, short communication channels, open doors and helpful, committed colleagues. Flexible working hours with partial home office for a good work-life-balance and an attractive remuneration and company pension scheme. How? For further information do reach out to recruitment manager Lise Sønnersgaard, email lise.sonnersgaard@pharmarelations.dk or by phone + 45 60981303 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders.

2021-10-04

UNEEG medical

Senior Regulatory Affairs Professional

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Senior Regulatory Affairs Professional
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. Senior Regulatory Affairs Professional As our new Senior Regulatory Affairs Professional, your main responsibility will be to ensure regulatory strategies for new products and changes to existing products are performed according to project plans. Further, you will have a key role in implementing the Unique Device Identification (UDI) requirements and upload data to EUDAMED, when available. Our first product solution for monitoring and analysing brain activity (EEG) aimed at improving the lives of fellow humans, impaired by epileptic seizures is available on the European market. The product portfolio consists a sterile active implant, a sterile insertion tool and a recorder that communicates with the implant. Further, we have software products for transfer of data. The products are developed under the directives for active implantable medical devices and we are currently in transition to the European Medical Device Regulation (MDR), where the devices mainly will be of class III. The department: You will be joining 7 highly dedicated and skilled colleagues in the QA/RA department. You will become part of an ambitious team with an informal relation, good humour and where we take care of each other. We are open and honest and appreciate a colleague who takes responsibility and have a positive approach to new challenges. The QA/RA department have close cooperation with different stakeholders. As UNEEG medical is a small company, the QA/RA department cover a broad range of tasks such as participating in development projects, maintaining and implementing new requirements in the quality management system, supporting manufacturing activities and market expansions. Key responsibilities include: Ensure professional and proactive regulatory support in the development projects Define the regulatory strategy within development projects and change projects to ensure a fast-to-market approach. Submission of device files to authorities Maintaining and improving regulatory processes such as labelling requirements and UDI Conduct medical device intelligence review including monitoring of legislation and standards Requirements: You have a Bachelor or a Master degree in relevant field of natural science, for example within biomedical engineering Minimum 2 years of experience in a regulatory position within medical devices - preferable you have been working with devices that contains electronics Experience with EU and US legislation for medical devices is required To succeed in the job, you are collaborative, have a structured approach, are proactive and have an eye for details while keeping the overview Given the international environment of UNEEG medical, English is our corporate language. You will use English in your daily work, which requires that you speak and write English at a high level. About UNEEG medical A/S UNEEG medical A/S is an entrepreneurial and ambitious company specializing in providing the epilepsy community with more accurate knowledge of seizures to support improvement in epilepsy care, ultimately aiming at improving patients’ quality of life. Our unique subcutaneous EEG solution for remote monitoring of brain activity was CE marked in 2019 and our continued international growth and technology roadmap ambitions will require several new functions and competencies in the years to come. UNEEG medical A/S was founded in 2005. We currently employ approximately 100 people in Europe – the majority of these are situated in our new headquarters in Allerød, Denmark. Our employees represent various cultures, backgrounds, skills, and years of experience. Read more about us at www@uneeg.com

2021-09-20

BK medical

Senior Biocompatibility Specialist

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Senior Biocompatibility Specialist
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. Located: Copenhagen We are currently partnering with BK Medical, an innovative ultrasound medical device company looking to recruit a Senior Biocompatibility Specialist to join their newly established team R&D Reprocessing and Biocompatibility in Copenhagen. As a Senior Biocompatibility Specialist, you will perform the biological evaluations and plan the activities managing the biological and chemical testing at contract laboratories. This also includes writing the biological evaluation reports, ensuring that communication of scientific data is done in a structured way. You will support and add value to the R&D projects and registration of devices, being the go-to person and Subject matter Expert within biocompatibility and toxicology. Preferably you have experience with ISO 10993 standards, biological and chemical testing of medical devices, and in preparing biological evaluation documentation. Knowledge in toxicology, or with reprocessing and sterilization methods, or with REACH and ROHS regulations is a benefit. You are used to working in an international setting, in a profound engineering setting and a dynamic environment, where your knowledge within biocompatibility is crucial. Key responsibilities include: The Senior Biocompatibility Specialist for BK Medical will be a vital person in a team of four, working with biocompatibility and validation of methods for cleaning, disinfection, and sterilization of BK products. You will contribute with your knowledge within biocompatibility, toxicology and various test methods in R&D innovation projects and projects on implementing new methods for cleaning, disinfection and sterilization. You thrive with responsibility and have the courage to learn new complex areas while applying your knowledge and experience on biocompatibility and toxicology. Requirements: Master’s or bachelor’s degree in Pharmacy, Chemical Engineering or related Experience with biocompatibility and/or toxicology - ISO 10993 standards Experience in biological and chemical testing for devices Good understanding of R&D processes for medical devices. Detail oriented and structured Driven and positive personality Pragmatic and systematic Used to work in an international environment Why? BK Medical has a unique technology within ultrasound and few competitors in the market. Driven by an expansive strategy BK Medical is expanding into new and exciting business areas using the newest technologies – from AI, Robotics and machine learning. BK Medical has a global footprint with 650 employees in USA and close to 200 employees in DK - representing the full value chain- from Development – Production and Sales. How? For further information do reach out to Head of Recruitment Ida Wenger-Parving on 2633 4301 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or geneticinformation; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-09-09

UNEEG medical

Senior Process Specialists

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Senior Process Specialists
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. Located: Copenhagen We are currently partnering with UNEEG medical an innovative medical device company looking to recruit a Senior Process specialist to join their internal team in Allerød. As a Senior Process Specialist, you will be responsible and ensure the principles for design control within UNEEG medical Quality Management System (QMS). You are highly motivated by optimizing and improving processes in collaboration with key stakeholders within the organization. You take pleasure in supporting and communicating to internal stakeholders how to adequately use the design control principles in product development and product sustaining projects. You will be the subject matter expert (SME) within Design control, which mean that you will be the go-to person and train colleagues in the principles and related design control procedures. You are familiar with the whole lifecycle for medical devices, understands how the technical documentation is built and preferably have hands-on experience with records from the technical documentation. Key responsibilities include The Senior Process Specialist for UNEEG medical will be a key person within the system engineering team of 7, working in close cooperation with the team and internal stakeholders. You are motivated by being the Subject matter expert within Design control and has good experience from previous positions on how to implement, communicate and execute the activities related to the area. Your mindset is pragmatic, quality orienteered and preferable with a high level of process structure. You find pleasure in training and teaching others, so the design control principles will become a more integrated part of the development projects. As the SME for design control, you will take part in audits. Requirements: Master’s or bachelor’s degree in engineering or related Extensive knowledge of ISO13485, Medical Device Regulation 2017/45, FDA21 CFR part 820 Experience with risk management per ISO14971:2019 – preferably also hands-on Excellent communication skills Hands-on experience with design control and writing QMS procedures You have an analytical and structured approach to your work, but at the same time, you are open-minded and see possibilities You are a team player, but appreciate responsibility and to work independently You are proactive, good at prioritizing, planning, and finalizing your tasks. Ideally you have experience with products that contain both hardware and software components Why? UNEEG medical A/S was founded in 2005 and is an entrepreneurial and ambitious company pioneering cognitive technologies that collect, monitor, and analyse brain activity (EEG). The device can be used for medical and diagnostic purposes within epilepsy ad detect and alert diabetics of severe hypoglycaemia, hence aiming at improving patients’ quality of life. UNEEG medical employs approximately 90 people. How? For further information do reach out to Head of Recruitment Ida Wenger-Parving on 2633 4301 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or geneticinformation; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics

2021-09-06

UNEEG medical

System Engineering

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System Engineering
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. Located: Copenhagen We are currently partnering with UNEEG medical an innovative medical device company looking to recruit a System Engineer to join their internal team in Allerød. As a System Engineer at UNEEG, you have a strong mindset for requirements engineering and risk management. You bring a technical insight, which supports both areas. Our devices are complex and innovative and entails working with SW, electronics, and mechanics. You bring knowledge of requirement management within one or preferably more of these areas and will be given the opportunity to gain more knowledge within all of them and not at least – their interfaces. Risk management is an important process when developing medical devices and as a System Engineer, you will be responsible for conducting and facilitating the safety risk management process with the cross functional product development teams, preparing and maintaining the risk management file. You bring knowledge of working with risk management within one or preferably more of the areas of SW, electronics and mechanics. You will be the go-to-person and facilitate workshops, trainings, and other activities within both requirements engineering and risk management, including support to other design control tasks during the lifecycle of the devices. You can work in a cross functional setting, a dynamic environment, where your expertise within requirement engineering and risk management, is essential. You act as a team player and support to team members comes natural to you. Key responsibilities include The System Engineer for UNEEG medical will be a vital person within the system engineering team of 7, working in close cooperation with the team and the other departments in R&D, Clinical and QA/RA. You thrive with responsibility and have the courage to implement and influence processes to the better. Taking on the task as system engineer requires a high level of technical understanding and engineering curiosity. You are self-motivated and can structure and manage own tasks. You possess good communication and interpersonal skills, while at the same time has a structured working method, eye for details and a pragmatic openminded approach. Requirements: Master’s or bachelor’s degree in engineering or related Experience from regulated businesses – preferable Medical devices Hands-on experience working with requirement management Hands-on experience working with safety risk management under relevant standards such as EN/ISO 14791 Good understanding of R&D processes for medical devices Detail orienteered and structured Team player Why? UNEEG medical A/S was founded in 2005 and is an entrepreneurial and ambitious company pioneering cognitive technologies that collect, monitor, and analyse brain activity (EEG). The device can be used for medical and diagnostic purposes within epilepsy ad detect and alert diabetics of severe hypoglycaemia, hence aiming at improving patients’ quality of life. UNEEG medical employs approximately 90 people How? For further information do reach out to Head of Recruitment Ida Wenger-Parving on 2633 4301 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or geneticinformation; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics

2021-09-03

UNEEG medical

Senior Usability Engineer

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Senior Usability Engineer
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. Located: Copenhagen. We are currently partnering with UNEEG medical an innovative medical device company looking to recruit a Senior Usability Engineer to join their internal team in Allerød. As a Senior Usability Engineer you will have the opportunity to set your fingerprint as to how usability engineering is integrated and executed in the development process, both in terms of our internal processes and hands-on during the development phases. You understand the regulatory requirements and will be the go-to person and assist in putting structure and processes up to ensure the integration of usability engineering in our product development process. You can work in a cross functional setting and can engage in establishing user interface and design iterations in a dynamic environment, where your hands-on-experience with usability engineering is a crucial expertise addition. Key responsibilities include: The Senior Usability Engineer at UNEEG medical will be a vital person within the system engineering team of 7, working in close cooperation with the other departments in R&D, Clinical, QA/RA and Marketing. You will proactively come up with ideas on how usability engineering can be integrated as a value adding part of product development. You thrive with responsibility and have the courage to implement and influence processes to the better. Taking on the task as Senior Usability engineer require not only a high level of engineering and technical understanding, but also a good portion of social skills and humour, - it should not be the first time you work with complex innovative products. Requirements: Master’s or bachelor’s degree in engineering or related Solid experience with usability engineering including creation of documentation, formative & summative evaluations, risk management Good understanding of R&D processes for medical devices. Experience with IEC62366-1:2015, FDA guidance for human factors (2016), and ISO14971:2019 Detail orienteered and structured Driven and positive personality Why? UNEEG medical A/S was founded in 2005 and is an entrepreneurial and ambitious company pioneering cognitive technologies that collect, monitor and analyse brain activity (EEG). The device can be used for medical and diagnostics purposes within epilepsy ad detect and alert diabetics of severe hypoglycaemia, hence aiming at improving patients’ quality of life. UNEEG medical employs approximately 90 people How? For further information do reach out to Head of Recruitment Ida Wenger-Parving on 2633 4301 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression,

2021-09-01

Zoetis

QA for Production

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QA for Production
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. Quality Engineer - QA for Production PharmaRelations is now recruiting a Quality Engineer - QA for production at Zoetis. The position is based in our office in Farum with reference to the Site Quality Lead. Zoetis is a global leader within animal health products and is moving fast in developing point of care instruments and diagnostics. With a R&D and production site at Farum, you will have your stakeholders and colleagues close by. In the role as QA for production it is vital that you can develop and mature the QA processes with specific focus on Compliant handling, Deviation/CAPA, and batch release. Further, you will be QA for the processes around the production and engineering teams. You excel in communication and thrive with the role as “ambassador” for Quality in the organization. With your experience from production within ISO-certified or regulated industries, you will bring know-how and expertise to the full end-to-end process. You see this role as combining your interest to grow a Zoetis QA excellence department even further with the team. You will be responsible for key assignments – such as CAPA process, validation, documentation, and case handling. This also includes batch release and complaint handling. You have a flair for various technical aspects in production and quality documentation systems and have a keen interest and experience with good communication capabilities. About you We are looking for a skilled and motivated QA specialist for production that has a natural interest in making QA a value- adding support for the business mainly production, but also Engineering and R&D Projects. You happily share your knowledge about your field of expertise when needed. As a team player you value your colleagues and their competencies and personalities. You manage to work cross functional in an international setting and bring pragmatic solutions to the table in a vibrant work environment. We believe you have a degree in engineering or life sciences. As a person, you have good interpersonal communication and listening skills. The organization will benefit from your proactive behaviour and solution orientered mindset. Competencies Degree in engineering or life sciences Working knowledge as QA for production and/or engineering Understanding of industry standards as GMP or ISO Experience in working with device or pharmaceutical industry QMS systems skills Fluent in danish and English Zoetis is an agile company with flat organisational structure and a great ability to empower their staff. Your application For further information please contact Ida Wenger-Parving, Head of recruitment at PharmaRelations;+45 26334301 or ida.parving@pharmarelations.dk. We will evaluate the applications on an ongoing basis but no later than 30th of September 2021. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-08-25

Kunde & Salgssupporter

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Kunde & Salgssupporter
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. Kunde- og Salgssupporter til Nordisk team inden for Medical Device For Hollister Inc. søger vi en dynamisk og serviceorienteret kunde- og salgssupport medarbejder. Bosiddende i Storkøbenhavn eller Nordsjælland. Dine kerneområder vil blive at yde service og kundepleje for vores eksterne kunder (sygeplejersker, distributører og patienter) samt interne stakeholders (salg, marketing, Market Access, kontor). Dine ansvarsområder: Supportere og drive egne arbejdsopgaver for det svenske og norske marked, samt ved ferie og fravær supportere Danmark. Assistere den interne salgsorganisation med div. opgaver fx udbud, marketing materiale mv. Holde styr på logistikken, ordrehåndtering, reklamationer, varemodtagelse m.m. Tæt samarbejde med den nordiske organisation Telefonkontakt og skriftlig kommunikation med kunder og interessenter Om dig Du har et højt energiniveau og godt drive Du er proaktiv, og arbejder selvstændigt, har lyst til at prøve kræfter med nye opgaver Du er kundeorienteret, service minded og hjælpsom Det falder dig let at strukturere dit arbejde, og du har styr på tingene Du er fleksibel, har et positivt mindset, og har en udpræget ”can do”-attitude Du er en ”ørn” til MSOffice pakken, SAP og andre administrative systemer Du har erfaring med kundeservice eller back office opgaver Det er et ufravigeligt krav at du taler og skriver enten flydende svensk eller norsk, og meget gerne dansk Du skal være velkommen til at uploade din ansøgning og CV via vores hjemmeside www.pharmarelations.dk. Ansøgninger behandles løbende, sidste frist for ansøgning er den 15.september 2021. For mere information kontakt den ansvarlige hos PharmaRelations, Ida Wenger-Parving på mail: ida.parving@pharmarelations.dk. Har du spørgsmål er du velkommen til at ringe til Ida på telefon +45 26 33 43 01. NB! CV og ansøgninger modtages ikke på e-mail. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-08-16

Senior QA Engineer

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Senior QA Engineer
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. Located: Copenhagen. We are currently partnering with BK Medical, an innovative ultrasound medical device company looking to recruit a Senior Quality Assurance Engineer (QAE) to join their internal team in Copenhagen. As a Senior Quality Assurance Engineer, you have a solid understanding of the quality requirements for medical devices and feel comfortable in coaching and advising colleagues on Quality related aspects. You will participate in technical complex and cross-functional R&D projects, where your Quality input and knowledge is adding value to the business. You have a solid understanding of design control, robust design and transfer process and risk management according to ISO 14971. You are used to work in an international setting, in a profound engineering setting and a dynamic environment, where your expertise within Quality and design control is crucial. You will be the go-to person and assist in ensuring structure, that processes are followed and the integration of design control and risk management in R&D projects. Key responsibilities include: The Senior Quality Assurance Engineer for BK Medical will be a vital person within the Global RA & QA team working in close cooperation with RA, Marketing and R&D. You thrive with responsibility and have the courage to implement and influence processes to the better. Taking on the task as Senior Quality Assurance Engineer requires not only a high level of engineering and technical understanding, but also a good portion of social skills and humour - it should not be the first time you work with complex innovative medical device products. Requirements: Master’s or bachelor’s degree in engineering or related Solid experience with QA engineering including documentation, validation & risk management. Strong understanding of R&D processes for medical devices. Proven track record of reviewing USR, SRS, risk management files, UEF and V&V + 5 years’ experience from a similar role in the medical device industry Detail oriented and structured Driven and positive personality Pragmatic and systematic Used to work in an international environment Why? BK Medical has a unique technology within ultrasound and few competitors in the market. Driven by an expansive strategy BK Medical is expanding into new and exciting business areas using the newest technologies – from AI, Robotics and machine learning. BK Medical has a global footprint with 650 employees in USA and close to 200 employees in DK - representing the full value chain- from Development – Production and Sales. How? For further information do reach out to Head of Recruitment Ida Wenger-Parving on 2633 4301 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.

2021-08-11

PharmaRelations AB,Filial DK

Market Access Manager

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Market Access Manager
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. On behalf of one of our clients we are currently looking to recruit a Market Access Manager, full time. Candidates who has experience from previous market access positions and Pricing and Tender including Danish Medicine Council would be of interest to hear from. The offices are in Copenhagen area, but work from home is possible, so we invite candidates from other geographical areas as well. As a Market Access Mgr., you will be responsible for the oversight of deliver product access to the Danish Medicine Council and lead market access initiatives across the 5 Danish regions including the work on guidelines and recommendation list. Key responsibilities include: Project Management Develop a project plan for each submission and ensure that all required company inputs are delivered on time Manage relationships with selected vendors to deliver submission on time and to budget Organize and chair internal kick-off meetings for stakeholders Market Access To maximise opportunity for all brands by ensuring payer stategy is aligned with business objectives Support development of value propositions and payer objectives for selected brands Tender management Follow tender best practices incl. environmental shaping Develop business cases for pricing committee Requirements: Previous experience of Market Access and writing submissions (the full process) Experienced in developing high quality technical documentation for externals Takes responsibility and initiatives Strong interpersonal and communication skills Worked in multiple therapy areas, in particular Rheumatology/Dermatology Why? Our client is a multinational pharmaceutical company, really a major player on the market. How? For further information please reach out to recruitment manager Lise Sønnersgaard, email: lise.sonnersgaard@pharmarelations.dk or by phone 60981303. Please apply via the link below. Due to GDPR we cannot recieve any CVs via email. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-08-03

Ferring Pharmaceuticals A/S

Global Regulatory Affairs Managers

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Global Regulatory Affairs Managers
PharmaRelations are supporting Ferring, an innovative and fast growing company in recruiting of 2 Global Regulatory Affairs Managers, preferably senior profiles to join their Regulatory team in Ørestaden, Copenhagen. Both positions are office based with flexibility to work from home, and both are full time. The 2 positions are in 2 different CMC teams: one in Gastro&Urology and one in Reproductive Medicines and Maternal Health. For the position in Gastro&Urology the task is to ensure registration of a new innovative microbiome compound which is expected to be of huge importance as a solution for patients worldwide suffering by Clostridium Dificile. The second position is aimed to focus on ensuring registration in developing countries of a non-profit product against post-partum bleeding in collaboration with WHO as well as being responsible for a product with the same active substance approved world wide. You will become an important part of Ferring’s Global Regulatory Affairs CMC department team of 38 dedicated colleagues based in five teams in Copenhagen, Israel or Switzerland. Key responsibilities include: Responsible for regulatory submissions and approvals for worldwide market expansions and renewals In the senior position, provide regulatory CMC strategy and expertise to cross-functional teams such as the Global Regulatory Project Teams, CMC Teams, Product teams and Launch Teams In the senior position, represent Global RA in the due diligence process and provide RA CMC input Perform regulatory impact assessment of CMC changes for established products and drug substances, ensure that adequate documentation is generated, submitted and approved timely worldwide In the senior position, drive and execute Scientific Advice with national Competent Authorities Participate actively in development and optimization of departmental and working processes In the role you will work in an international environment and have interfaces with many different disciplines including other Global Regulatory disciplines, Global Pharmaceutical R&D, Manufacturing sites, Product Supply, Ferring’s affiliates and development sites around the world. Requirements: Degree in life science or pharmacy For the senior position at least minimum of 7 years’ experience from a similar global RA position where RA CMC experience is a must For the non-senior position more than 3 years of experience in global regulatory affairs, preferably within regulatory CMC activities For the Gastro&Urology position, experience with biological substances is preferred as well as experience from development projects Experienced with MAA/NDA/BLA submissions in Europe, US and Rest of the World For the senior position and especially within Gastro&Urology, experience from Scientific Advice with EMA, FDA and other Health Authorities is required, Experienced from work with variation applications for FDA, EMA and preferably also other markets For the RMMH position, additional to your RA competence, experience from QA, manufacturing site or pharmaceutical R&D will be considered valuable Fluent in written and spoken English A focused, structured dedicated person able to work independently but at the same time also a true team player Ability to proactively drive activities, take decision and deal with ambiguity Why? Ferring Pharmaceuticals is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. At Ferring International Pharma Science Centre (IPC) in Copenhagen we are nearly 600 people, primarily scientists and specialists breaking new ground to help people live better lives all around the globe. We focus our R&D efforts on peptide-based drugs and biotechnology derived medicines. As a privately owned company we benefit from the privilege to think and work with a long-term horizon. You will experience the same freedom in your search for new solutions. Your desire to innovate and explore will contribute to fulfilling our ambition of becoming the world’s leading company within reproductive medicine and maternal health. If you need help, you will find it. If you want challenges, they are right in front of you. If you are looking for freedom to find your own way, you are trusted to do so. If you want to make a mark in the world for the better, you feel just like the rest of us. Read more at www.ferring.com How? For further information do reach out to recruitment manager Lise Sønnersgaard, email lise.sonnersgaard@pharmarelations.dk or by phone + 45 60981303 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, colour, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-07-26

PharmaRelations ApS

Regulatory Affairs Specialist, Danmark

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Regulatory Affairs Specialist, Danmark
PharmaRelations søger nu en Regulatory Affairs Specialist til en konsulentopgave hos en af vores kunder i lægemiddelindustrien, med start efter sommerferien 2021. Stillingen er tidsbegrænset 12 måneder med mulighed for forlængelse. Den helt rette kandidat har arbejdet med Regulatory Affairs eller Pharmacovigilance i et par år i den farmaceutiske industri. Den rette erfaring er et stort plus, men vi lægger også stor vægt på personlige kvaliteter. Stillingen er kontorbaseret i København (kan være hjemmebaseret under Covid-19) Primære arbejdsopgaver: Sikre vedligeholdelse af tildelte, godkendte produkter gennem rettidig indlevering af variationer og andre ansøgninger, PSURs mm. indenfor den aftalte tidsperiode, samt kommunikation af godkendelser til stakeholders. For tildelte produkter, sikre rettidig forberedelse og vedligeholdelse af lokale produktresuméer, indlægssedler, emballage og andre lovgivningsmæssigt gældende dokumenter i henhold til kundens og lokale standarder samt relevante Artwork Management procedurer. Opdatere og implementere produktresuméet indenfor den korrekte tidsramme for compliance. I forbindelse med indsendelse af variationer og fornyelser m.v. levere oversættelse og QRD-kontrol af produktresuméer og indlægssedler samt sikre kvalitetssikring, herunder sproglig kontrol af disse dokumenter. Sikre input af høj kvalitet til den artwork-ansvarlige, herunder indlægssedler og alle andre komponenter. Være opdateret på relevante EU- og lokale regler og guidelines for tildelte produkter og opgaver. Stedfortræder for andre RA kollegaer i forbindelse med ferie, sygdom mm. Du kommer også til at skulle håndtere dag til dag oprettelser af hændelser i overensstemmelse med globale PV procedurer og lokale regulativer. Oprettelse og behandling af Case Safety Reports (ICSRs) indenfor den angivne tidsramme. Deltage og bidrage til audits og inspektioner. Udarbejde og opdatere SOP´er. Træning og kommunikation af sikkerheds udfordringer. Personlige kvaliteter, som den rette kandidat besidder, er høj energi og stort drive, fleksibel indstilling, selvstændig, proaktiv og præstationsorienteret. Du tilegner dig viden ekstremt hurtigt og har et stort engagement. Du er en positiv person og har fokus på forretningen. Du kommunikerer ubesværet på skrift og i tale på både dansk og engelsk. PharmaRelations tilbyder dig en inspirerende og engageret arbejdsgiver, hvor du som medarbejder får gode muligheder for at udvikle dig. PharmaRelations tilbyder dig samtidigt et selvstændigt og stimulerende arbejde i et firma med høje ambitioner, og et klart fokus på vækst og resultater. Vi tilbyder et arbejdsklima baseret på engagement og korte beslutningsveje. Høj kvalitet i leverancen til vores kunde er nøglen til vores fælles succes! Lyder det interessant? Du skal være velkommen til at sende din ansøgning og CV via hjemmesiden www.pharmarelations.dk. Ansøgninger behandles løbende, sidste frist for ansøgning er den 31. August 2021. For mere information kontakt den ansvarlige hos PharmaRelations, Louise Brinking på + 45 53 76 95 70 eller Louise.brinking@pharmarelations.dk Søg stillingen hér:

2021-07-08

Ferring Pharmaceuticals A/S

Clinical Project Data Manager

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Clinical Project Data Manager
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. We are currently partnering with Ferring an innovative company looking to recruit a Clinical Project Data Manager to join their Data Management team in Ørestaden, Copenhagen. The position is office based, full time. As a Clinical Project Data Manager, you will be responsible for driving the clinical trials forward. You will be overall responsible for your projects and be the main driver from setup to closure. As part of this you will develop and manage project plans and decide the work distribution between yourself and the off-shore data management team in India. You will become an important part of our dynamic team of 5 very experienced and highly motivated Data Managers. In addition we have a team of 11 off-shore external Data Managers based in India. We are part of Global Biometrics, meaning that we also work closely together with colleagues in Japan, China and USA. Key responsibilities include: Plan and execute the setup and data collection and handling in clinical trials Ensure the cross functional coordination and alignment of the data management related processes in clinical trials Ensure high quality in all the data management deliverables Ensure submission-ready SDTM data Participate in cross-functional improvement projects and drive innovation Requirements: Good experience in clinical databases, standards and trials Experienced in clinical trial setup, conduct and closure – you have finalised at least 1-2 projects Experienced in CDISC standards (SDTM and CT) and SAS is a must Open minded towards trying new technologies, and ways of working You are a technical savvy – probably with a technical background Danish and English fluently skills in both talking and writing Why? Ferring Pharmaceuticals is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. At Ferring International PharmaScience Center (IPC) in Copenhagen we are nearly 600 people, primarily scientists and specialists breaking new ground to help people live better lives all around the globe. We focus our R&D efforts on peptide-based drugs and biotechnology derived medicines. As a privately owned company we benefit from the privilege to think and work with a long-term horizon. You will experience the same freedom in your search for new solutions. Your desire to innovate and explore will contribute to fulfilling our ambition of becoming the world’s leading company within reproductive medicine and maternal health. If you need help, you will find it. If you want challenges, they are right in front of you. If you are looking for freedom to find your own way, you are trusted to do so. If you want to make a mark in the world for the better, you feel just like the rest of us. Read more at www.ferring.com How? For further information do reach out to recruitment manager Lise Sønnersgaard, email lise.sonnersgaard@pharmarelations.dk or by phone + 45 60981303 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, colour, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-07-02

Novartis

Medical Manager

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Medical Manager
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. We are currently partnering with Novartis - an innovative and prestigious Pharmaceutical company looking to recruit a Medical Manager who will be responsible for driving the launch preparations for new products to join their team in Denmark. The position is field based and full time. As a Medical Mgr. focused on pre-launch you will be responsible to lead the account work and planning during the pre-launch phase and involve suitable cross-functional stakeholders to deliver "state of the art" Novartis launches within the cardiovascular, renal and metabolic area. You will be the driver for account relevant medical scientific projects to meet local needs, as well as responsible for locally run studies, acting in collaboration with relevant Medical Leader, Market Access, Nordic RWE team, Sales and Marketing as well as the Nordic R&D/pipeline team. Key responsibilities include: Co-create the local launch strategy together with relevant functions Driving the launch preparations for the relevant accounts within the Therapeutic Area Leads medical scientific projects to meet local needs and acts in collaboration with Medical Leader, Market Access, Nordic RWE team, Medical information, Sales and Marketing Responsible for investigator-initiated trials as well as locally run Novartis sponsored trials Builds positive relationships with the respective accounts, such as Guideline Committees, Drug formulary Committees and National recommendation groups. Secures an in-depth understanding of our data in the context of the therapeutic area. Collects impactful insights and finds opportunities to innovate and digitalize. Requirements: Solid scientific background with a minimum of MSc Degree In-depth and holistic understanding of the health care system, stakeholder system, needs, and patient journeys. knowledge of industry, competitors, relevant market dynamics Appetite for new technologies, digital savvy Emotional intelligence, self-aware Great teammate and efficient collaborator, able to build positive relationships Concise communication & presentation skills, knows how to summarize and communicate the key points and business case to others Fluency in Danish and English Holds a driving license Why? Novartis embraces diversity, equal opportunity and inclusioin. We are committed to building diverse teams. We strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. How? For further information do reach out to Recruitment Manager Lise Sønnersgaard email lise.sonnersgaard@pharmarelations.dk or by phone +45 60981303 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-06-21

AJ Vaccines

VP Quality

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VP Quality
VP Quality PharmaRelations is the Nordic market leader within talent services for the Life Science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. We are currently partnering with AJ Vaccines to recruit a VP Quality to join the executive management and head up the Quality Team in Copenhagen, Denmark. The position is full-time, and office based in central Copenhagen. As VP Quality your objective will be to develop and ensure the overall Quality strategy, including support development of production systems - validation and quality management systems. You have full responsibility over internal and external audits, and inspections while driving the quality agenda. It is crucial to drive productivity and simplicity while improving quality performance, including readiness for inspections. The VP Quality is responsible for an organization of 140 employees with 7 direct reports. As the leading Quality person in AJ vaccines, and part of the executive management group, you ensure collaboration and cross functional Quality knowledge sharing. Collaboration and work between the different business units, understanding of and implementing quality, will be an important part of the role. Therefore, the right candidate must have and demonstrate the right mindset and understanding between Quality and Production. Success criteria: To become a success in this role it is vital to establish a strong relationship between the production sites and the businesses units. To master lead time, ensure decision making among the functional leaders and establish an environment of risk-based Quality, knowledge sharing, cross- functional thinking and team spirit. Be a strong contributor to AJ Vaccines culture journey. Key responsibilities include: Set the strategic direction of Quality at AJ Vaccines Develop, coach and support leaders Ensure, drive and facilitate the Quality agenda at all levels Foster a quality driven business and team oriented mindset Encourage performance driven behavior and processes Be a lead role in EMT on quality related issues Set clear goals – within cost-effectiveness, lead time, quality of work and new technology in QC Requirements: +10 years of proven track record in Quality management from GMP regulated industry Ms. degree within production, pharmaceutical or engineering Proven record within change and performance management Solid stakeholder management skills Strategic thinking - with a strong implementation acumen Pragmatic and solution focused Robust and agile mindset Why? AJ vaccines offer an interesting, diversified, and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern organization and a professional environment where you will have the opportunity for personal growth. How? For further information do reach out to Head of Recruitment Ida Wenger-Parving on +45 2633 4301 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, colour, ancestry, national origin, ethnic group identification, age. Religion, marital or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-06-17

BK Medical

Team Manager - Design, Risk and Usability

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Team Manager - Design, Risk and Usability
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. We are currently partnering with BK medical an innovative ultrasound medical device company looking to recruit a Team Manager for a team of usability, risk and design specialist in Copenhagen. As a Team manager you will be responsible for the development of the area within Design control, Risk management, Traceability and usability Engineering. You will lead and coach your team on a daily basis while helping out in the daily task – whether its processes, standards within usability engineering from testing, documentation, and risk management. You have solid understanding of the regulatory requirements, and upcoming MDR. You can work in a cross functional setting, in a profound engineering setting and dynamic environment, where your expertise within the capabilities of your team are crucial. You have board knowledge of R&D processes, and while taking a strategic approach you are pragmatic and hands-on. You will be the go-to -person and assist in putting structure and processes up and ensure the integration of UE in design control and risk management. Full budget responsability. Key responsibilities include: The Team manager will be a vital person within the team of four specialist within Design control, Risk, Traceability and Usability engineering. The team will be based in RD and the daily work will be in close corporation with RA, QA and Marketing You will proactively come up with ideas on how the Teams can be integrated as a value adding part of product development. You thrive with responsibility and have the courage to implement and influence processes to the better. Taking on the task as Team Manager require not only a high level of engineering and technical understanding, but also a good portion of social skills and humour, - it should not be the first time you work with complex innovative products. Requirements: Master’s or bachelor’s degree in engineering or related Solid experience within Design control, Risk and usability engineering including documentation, testing, risk management, UE file etc. Good understanding of R&D processes from medical devices. Experience with IEC62366-1:2015, FDA guidance for human factors(2016), and ISO:14971:2019 4-6 years experience from one of the areas- design, risk or usability and aspire to leadership Detail orienteered and structured Driven and positive personality Use to work in an international environment Why? BK medical has a unique technology within ultrasound and few competitors in the market. Driven by an expansive strategy BK medical is expanding into new and exciting business areas using the newest technologies – from AI, Robotics and machine learning. BK medical has a global footprint with 650 employees in USA and close to 200 employees in DK - representing the full value chain- from Development – Production and sales. How? For further information do reach out to Head of Recruitment Ida Wenger-Parving on 2633 4301 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or geneticinformation; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-06-10

Team manager QMS & IT

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Team manager QMS & IT
Team Manager for QMS & IT department Are you passionate about continuous improvement, quality systems compliance, and leading and developing a team of dedicated quality compliance specialists? We are currently partnering with Orifarm Generics looking for a talented Team Manager for QMS & IT department, who is driven by leading and developing their team as well as ensuring compliance and continuous improvement of quality systems. The position is located in Orifarm´s Head Quarters in Odense with flexibility to work from home. About the job As a Team Manager QMS & IT, you will be working with a team of 5 highly trained Quality Compliance specialists, where your responsibility will be to efficiently distribute and coordinate daily tasks, set priorities, and establish clear targets, as well as handle several hands-on operational tasks. The team has several vital duties including implementing and ensuring compliance and continuous improvement of Pharmaceutical Quality System as well as other electronic quality systems within the organization. It´s also a team´s task to follow up on the current legislation for pharma products and medical devices, as well as to supporting and sparring with other QA departments in Orifarm. About you For the success in the role as Team manager QMS & IT, it is vital that you have a good know-how and experience within QMS&IT and GMP, which is combined with solid leadership experience. We expect you are able to support your team in their daily tasks and at the same time, you are able clearly define team strategy, set targets and priorities, and delegate responsibilities within your team. You are expected to ensure the right performance of individuals and whole your team and at the same time, to efficiently coordinate with other departments in order to deliver on Orifam´s strategic targets. We expect you meet these requirements: Master’s degree in engineering or pharmaceutical, sciences 3-5 years’ experience with leadership of specialists Deep know-how and hands-on experience with QMS & IT systems Continuous improvement toolbox and mindset Process oriented and structured approach Courage to make decision and to set direction also for others Self-driven and positive personality with motivated by cooperation International and cross-functional mindset About Orifarm Starting out with a strong entrepreneurial mission, Orifarm was founded in 1994 by Birgitte and Hans Bøgh-Sørensen. The underlying explorer spirit still characterizes the company, and with high ambition, we are constantly looking for new opportunities and business areas to invest in. Our purpose of being is to create competition and provide important savings for society and to ensure better value for money for consumers. We strive to make this happen while insisting on being good colleagues, improving together, helping each other, and innovating. We operate within three main business areas: Parallel Import, Generics, and New Bizz. We are the largest parallel importer of pharmaceuticals in Europe and the largest supplier of pharmaceuticals in Denmark. We hold a strong position in Generics in the Nordics, being the largest producer of over-the-counter medicine in Denmark. Our portfolio contains well-known brands such as Pamol, Kodimagnyl, and Apovit. Within New Bizz, we aim to expand our business by exploring new opportunities within pharmaceuticals. About the process For further information do reach out to Head of Recruitment Ida Wenger-Parving on 2633 4301 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, colour, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-06-02

Medtronic

Clinical Robotics Specialist

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Clinical Robotics Specialist
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. We are currently partnering with Medtronic and their Surgical Robotics Operations Unit. They are looking to recruit four Clinical Robotics specialist/ start-up specialist to join their internal team in each of the Nordics countries. The position is home-/office based, full-time and travel must be excepted. As a Clinical Robotics Specialist/start-up specialist, you will be responsible for the oversight of successful integration of a new surgical robot into hospitals. Activities to integrate the Medtronic robot include in the assessment and change implementation to ensure adequate cleaning and sterilization reusable instruments, arranging the off-site training of surgeons and supporting staff, updating surgeon preference cards, developing an inventory plan for robotic procedures, raising awareness of robotic surgery, and helping to schedule the use of the robot, among others. Key responsibilities include: Meet with the Director of Robotic surgery, together with your manager, to support the development of Robotic program goals and metrics for the Medtronic robot In concert with the Medtronic Field Service Engineer and the hospital staff, prepare the operating room to host the Medtronic robot Train hospital staff to clean and sterilize re-usable robotic instruments Monitor the surgeon training plan, assess attendance to the Medtronic’s off-site training as scheduled, arrange for proctored cases post-training in case of need. Develop a training plan for support staff in the OR and provide in-service training Conduct regular program review meetings with stakeholders Utilize change management techniques to engage clinical stakeholders in an optimized, safe and intense use of the robot in the OR. Train and coach Hospitals’ staff to promote skill transfer and achieve self-sufficiency in operational excellence. Requirements: Clinical knowledge - preferable Operating Room knowledge Industrial knowledge – Hospitals and healthcare sector Analytical and presentation skills Stakeholder management skills: Communication, relationship building and coaching Positive with a can-do attitude Business understanding International mindset Why? Medtronic is in the process of rolling out its robotic assisted surgery solution HUGO. You can be part of the EMEA team that will make this innovative surgical robot a success. How? For further information do reach out to your local Nordic Recruitment manager in Finland, Sweden, Denmark or Norway, or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-05-27

MedTrace Pharma A/S

QA Operations

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QA Operations
At MedTrace you will be a valued member of the team and take part in our exciting journey of bringing our innovative soft and hardware solution for heart patient diagnostics to market. The technology is ground breaking and is already now drawing international accreditation. MedTrace’s technology platform is a combination of an automated hardware system that is able to produce, dose and inject 15O-water, a very short-lived radioactive version of regular water and a software solution that makes the clinician able to draw conclusions about blood flow. The technique has potential for use in other organs and for diagnostic use in other diseases. MedTrace has offices in Lyngby, Denmark and affiliates in Boston and Uppsala. The company favours cross functional teamwork and hiring employees with diverse backgrounds. The company language is English. In MedTrace, all members are valued, we are all very dedicated and ambitious in reaching our common goals. Every day presents itself with plenty of exciting tasks, but we are high spirited with a good sense of HUMOR. The atmosphere is informal, and everybody in the team is heard. Our values include trust in each other, respect for people, responsibility and dedication. To become a success at MedTrace it is important to have an entrepreneurial mindset with a pragmatic approach to manoeuvre in a young organisation. The targeted markets are Europe, the US and later on Japan. The position as QA Operations The position as QA Operationsis new at MedTrace. You will get an exciting opportunity to exercise your knowledge within quality assurance in various different technical areas such as medical device, pharmaceuticals, hardware, software, etc.. The company has been working on the development of a QMS covering both 1) medical device and 2) pharmaceutical manufacturing equipment (scope of products). The QA Operations is expected to assist the Head of QA in the further establishment of the QMS and hereunder assist the process towards certification as will be required for the regulatory clearance of the Company’s products. In addition, the QA Operations will take a lead role in daily operational compliance tasks such as: Order handling Complaint handling Non-conformities Review of batch documentation from suppliers Procedure updates CAPA work Other QMS and compliance related tasks Projects related to operations and product life cycle and maintenance The job function has a cross-organizational reach to both sales, development, service etc. but the employee is expected to be self-driven, i.e. the QA Operations is expected to take own initiatives within the scope of the job description and properly align initiatives with the Head of QA. The job as QA Operations is full-time. Your main base of operation will be at head office in Lyngby Copenhagen, and MedTrace is flexible towards working from home. Background Your background is M. Sc. in the life science field or equivalent/relevant education. Ideally you have 1-3 years of work experience with quality assurance and/or compliance as well as knowledge og GMP and medical devices. Preferably you have experience with Quality Management systems, i.e., D4Infonet. You are experienced with Standard Operating Procedures and ISO 13485 is also among your knowledge. You also have knowledge of pharmaceutical legislation and GMP. Other qualifications: Strong in collaborative thinking and capability Able to work independently Proven track record within a QA role and cross functional collaboration Speaks and writes English fluently and profound IT skills in MS Office package Good understanding of Quality Management Strong in oral as well as written communication capabilities You thrive in the innovative environment that a development stage company can offer. Personal profile You are a “doer”. The company pulse is intense, but together we can accomplish almost everything. You want to make a difference and have an impact, and you like to see your input and ideas transformed into action swiftly. As a person you can simplify things, find solutions, and work collaborative. You are a responsible person, and you excel in maintaining focus even in busy times. You are a trustworthy person, and you value to get things done to a high quality level. Application For more information, please contact Lise Sønnersgaard, Recruitment manager at PharmaRelations, telephone +45 60981303 or lise.sonnersgaard@pharmarelations.dk. We will evaluate applications on a running basis, but we need your application no later than June the 14th 2021. You can apply here:

2021-05-27

MedTrace Pharma A/S

QA Clinical Trials

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QA Clinical Trials
At MedTrace you will be a valued member of the team and take part in our exciting journey of bringing our innovative soft and hardware solution for heart patient diagnostics to market. The technology is ground breaking and is already now drawing international accreditation. MedTrace’s technology platform is a combination of an automated hardware system that is able to produce, dose and inject 15O-water, a very short-lived radioactive version of regular water and a software solution that makes the clinician able to draw conclusions about blood flow. The technique has potential for use in other organs and for diagnostic use in other diseases. MedTrace has offices in Lyngby, Denmark and affiliates in Boston and Uppsala. The company favours cross functional teamwork and hiring employees with diverse backgrounds. The company language is English. In MedTrace, all members are valued, we are all very dedicated and ambitious in reaching our common goals. Every day presents itself with plenty of exciting tasks, but we are high spirited with a good sense of HUMOR. The atmosphere is informal, and everybody in the team is heard. Our values include trust in each other, respect for people, responsibility and dedication. To become a success at MedTrace it is important to have an entrepreneurial mindset with a pragmatic approach to manoeuvre in a young organisation. The targeted markets are Europe, the US and later on Japan. The position as QA Clinical Trials The position as QA Clinical Trials is new at MedTrace. You will get an exciting opportunity to exercise your knowledge within quality assurance in various technical areas such as medical device, pharmaceuticals, hardware, software, etc. but also in your work around the collaboration with external partners who conduct clinical studies. Your role will be to be the connection between external CRO companies doing clinical trials for Medtrace and you are expected to have an eye on how the studies are performing in terms of inclusion and performance, any quality issues and how is that mirrored in the protocol and in the QA system. Your task will also be to ensure issues are described in the QMS system. You will be stepping into the design and development phase of MedTrace´s products, so being able to execute on tasks in an efficient manner is key to your success. Your main base of operation will be at head office in Lyngby Copenhagen, and MedTrace is flexible towards working from home. You must expect some travelling in accordance with site visits. Profile Your key responsibilities will be: Ensure centralized monitoring in accordance with SOPs, regulations and guidelines. Monitor and document the Company’s clinical trial activities including trial design and protocol preparation. Interact with clinical stakeholders and internal resources during clinical trial preparation and execution. Ensure that clinical trial products are properly labelled and made available to the trial sites. Review and oversee the data collection throughout the trial. Participate in the continuous improvement of the function’s procedures to secure best practices. Background Your background is M. Sc. in the life science field/Pharmacist or similar relevant education. As a minimum you have 3 years of work experience with quality assurance including experience with clinical trials. Your experience also covers knowledge of the operational aspects in the setup and monitoring of clinical sites. Other qualifications: Experience with Quality Management System(s) Knowledge of ISO 13485 Knowledge of pharmaceutical legislation and GMP Experience with clinical trial management inclusive protocols/reports Experience with supply chain management, in particular clinical trials Good understanding of medical terminology and science associated with development of medicines Strong in collaborative thinking and capability Able to work independently Speaks and writes English fluently and profound IT skills in MS Office package Strong in oral as well as written communication capabilities You thrive in the innovative environment that a development stage company can offer. Personal profile You are a “doer”. The company pulse is intense, but together we can accomplish almost everything. You want to make a difference and have an impact, and you like to see your input and ideas transformed into action swiftly. As a person you can simplify things, find solutions, and work collaborative. You are a responsible person, and you excel in maintaining focus even in busy times. You are a trustworthy person, and you value to get things done to a high quality level. Application For more information, please contact Lise Sønnersgaard, Recruitment manager at PharmaRelations, telephone +45 60981303 or lise.sonnersgaard@pharmarelations.dk. We will evaluate applications on a running basis, but we need your application no later than June the 14th 2021. You can apply here:

2021-05-17

PharmaRelations ApS

Interim Key Account Manager hormoner

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Interim Key Account Manager hormoner
PharmaRelations søger nu en Key Account Manager til en konsulentopgave hos en af vores kunder i lægemiddelindustrien, der begynder snarest muligt. Stillingen er tidsbegrænset til 12 mdr. Du får ansvaret for salget af væksthormon og kvindelige hormoner, så det er en forudsætning at du har arbejdet med en af de to områder. Målgruppen er udvalgte endokrinologer og gynækologer. Arbejdet omfatter planlægning, implementering og opfølgning af salgsaktiviteter, samt udvikling og vedligeholdelse af relationer med dine kunder. For at lykkes i denne rolle er du en person, der er drevet af en dedikeret arbejdsindsats og skaber gode relationer. Du har evnen til at tilpasse dig hver enkelt kunde og det er et must for stillingen, at du har et godt fagligt netværk inden for kundesegmentet som beskæftiger sig med behandling af hhv. væksthæmning eller kvindelige kønshormoner. Du har erfaring som sælger mod ovennævnte kundegruppe gennem en årrække og kan dokumentere gode salgsresultater. Du er selvstændig, tager et stort ansvar i dit arbejde og trives med tydelige salgsmål. Med den rigtige holdning, beslutsomhed og dedikation ser du altid frem til at gøre det yderste for at lykkes. Om dig Tidligere erfaring som Key Account Manager/produktspecialist indenfor et eller begge områder Struktureret - tager ansvar, initiativ og har evnen til at arbejde selvstændigt Evne til at arbejde strategisk og omdanne virksomhedens strategi til taktik Et godt kendskab til mekanismerne indenfor licitationer Gode sociale kvaliteter, evne til at skabe langsigtede relationer med din kundegruppe Udpræget teamplayer, lyst og vilje til at samarbejde med kollegaer Taler dansk og engelsk flydende LIF-eksamen Kørekort til personbil. PharmaRelations tilbyder dig en inspirerende og engageret arbejdsgiver, hvor du som medarbejder får gode muligheder for at udvikle dig. PharmaRelations tilbyder dig samtidigt et selvstændigt og stimulerende arbejde i et firma med høje ambitioner, og et klart fokus på vækst og resultater. Vi tilbyder et arbejdsklima baseret på engagement og korte beslutningsveje. Høj kvalitet i leverancen til vores kunde er nøglen til vores fælles succes! Lyder det interessant? Du skal være velkommen til at sende din ansøgning og CV via hjemmesiden www.pharmarelations.dk. Ansøgninger behandles løbende, sidste frist for ansøgning er den 31.05.2021. For mere information kontakt den ansvarlige hos PharmaRelations, Lise Sønnersgaard på mail lise.sonnersgaard@pharmarelations.dk eller telefon 60981303

2021-05-17

ALK

Medical Science Liaison

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Medical Science Liaison
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. We are currently partnering with ALK, a leading global research-based innovative pharmaceutical company focused on allergy prevention and vaccinations against allergies. They are looking to employ a Medical Science Liaison (MSL) to join their Danish team. The position is mixed field/office based and full time. As a MSL, you will be responsible for the oversight of the KOL collaboration (pulmonologist, allergologists, paediatricians) by planning of relevant scientific strategies and implementations. The MSL takes part in the clinical study program, development of KOL plans as well as regular KOL contact. The MSL handles proactively and constructively Medical projects including close collaboration and liaison with internal functions and Nordic office. Key responsibilities include: KOL collaboration and KOL management Being updated in the scientific field Contribute to the scientific planning and execution of new and on-going trials Scientific support and education (internal and external) Participation in the Nordic Medical group collaboration and meetings Responsible for initiation and completion of Advisory Boards Close collaboration with the commercial team (Sales and Marketing) in the Nordics Support of medical affairs in the Nordics As agreed, collaboration with HCPs, relevant authorities, patients & patient associations and business partners Requirements: As a person you are a creative, ‘out of the box-thinking’ person. You thrive working in a team but are also comfortable by doing you tasks on your own. Your drive is strong, and you are an energetic individual with experience of operating to the professional standards of a pharmaceutical company. You are business minded and skilled in working with multi-functional processes, but able to stay focused on achieving agreed key objectives. Your communication skills are strong, and aiding implementation of projects/tasks, handling of potential cross-functional implication of implementation and general motivation. You have good people skills enabling establishment of team spirit and results in line with ALK values and ALK ways of working. You are flexible and work entrepreneuric but structured. Besides, you have an open mind, are positive and possess a good sense of humour. Academic degree preferably within health care Experience from working with the pulmologists, paediatricians, or within allergologists Experience from working as MSL or Account manager on a scientific level Pharmaceutical advisor (LIF) Why? ALK is a global allergy solutions company, with a wide range of allergy treatments, products and services that meet the unique needs of allergy sufferers, their families and healthcare professionals. More than 500 million people worldwide have allergies. Many of them suffer in silence because the way ahead is too confusing. With 100 years of experience, nobody knows allergy like us, and we continuously apply our scientific knowledge and expertise to help people take control of their allergy and their life. We want to make a difference by offering solutions for everyone who is touched by allergy – through a comprehensive range of products, services and resources that offer a fast-track to a more balanced life. How? For further information do reach out to recruitment manager Lise Sønnersgaard, on lise.sonnersgaard@pharmarelations.dk /tel. 60981303 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-05-12

Orifarm

Team manager QA- LCM

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Team manager QA- LCM
Team Manager for QA - Life Cycle Management department Are you passionate about leading and developing a team of dedicated specialists and do you have solid QA and GMP background? We are currently partnering with Orifarm Generics looking for a talented Team Manager for QA-LCM department, which is a newly created team. The successful candidate is driven by leading and developing their team as well as ensuring and developing high quality of the products and processes. The position is located in Orifarm´s Head Quarters in Odense with flexibility to work from home. About the job As a Team Manager QA-LCM, your task will be to create an environment, where the team spirit thrives and establish collaborative dynamics among approx. 10 specialized academics in QA - Life Cycle Management. The team has several vital quality-related tasks including Product Quality Reviews on all products and negotiating, maintaining, and updating technical agreements with different CMO´s. The QA-LCM team is also responsible for launch related activities in close cooperation with suppliers and colleagues from other departments. In addition, the team is involved in daily QA activities such as handling of deviations, change controls, claims, and CAPA. About you In the role as Team Manager QA-LCM your task is to support an inclusive environment and foster efficient collaboration in the team of trained QA professionals. It is therefore vital that you are able to clearly describe tasks, define targets and priorities, and communicate and delegate responsibilities within your team. As a Team Manager you will work alongside the team every day and assist in daily tasks. You are expected to ensure the right performance of individuals and your team and at the same time, to efficiently coordinate with other departments in order to deliver on Orifam´s strategic targets. You will be working in close collaboration with team managers from other QA teams and will be part of the QA management group consisting of 8 persons. We expect you meet these requirements: Master’s degree in engineering or pharmaceutical, sciences 4-6 years’ experience with leadership of specialists Solid understanding and hands-on experience within QA Process oriented and structured approach Courage to make decision and to set direction also for others Self-driven and positive personality International and cross-functional mindset About Orifarm Starting out with a strong entrepreneurial mission, Orifarm was founded in 1994 by Birgitte and Hans Bøgh-Sørensen. The underlying explorer spirit still characterizes the company, and with high ambition, we are constantly looking for new opportunities and business areas to invest in. Our purpose of being is to create competition and provide important savings for society and to ensure better value for money for consumers. We strive to make this happen while insisting on being good colleagues, improving together, helping each other, and innovating. We operate within three main business areas: Parallel Import, Generics, and New Bizz. We are the largest parallel importer of pharmaceuticals in Europe and the largest supplier of pharmaceuticals in Denmark. We hold a strong position in Generics in the Nordics, being the largest producer of over-the-counter medicine in Denmark. Our portfolio contains well-known brands such as Pamol, Kodimagnyl, and Apovit. Within New Bizz, we aim to expand our business by exploring new opportunities within pharmaceuticals. About the process For further information do reach out to Head of Recruitment Ida Wenger-Parving on 2633 4301 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, colour, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-05-12

Orifarm

Teamlead QA- Release support

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Teamlead QA- Release support
Team Manager for QA – Release Support afdeling Er du en erfaren leder med sans for struktur og effektiv planlægning, som brænder for kvalitet og GMP? Vi samarbejder med Orifarm Generics og søger efter en talentfuld Team Manager til QA-Release Support afdeling, som er drevet af at lede og udvikle sit team samt sætter pris på at have et stort ansvar og er i stand til at bevare overblikket, selv når der er mange bolde i luften. Stillingen er placeret i Orifarms hovedkvarter i Odense med fleksibilitet til at arbejde hjemmefra. Om jobbet Som den nye Team manager for QA-Release Support vil du lede, drive og udvikle et engageret og selvstændigt team på ca. syv medarbejdere med højt vidensniveau indenfor kvalitet og GMP. Teamets daglige drift består i at tilsikre, i tæt samarbejde med andre afdelinger, at korrekt dokumentation er tilgængelig i forbindelse med frigivelse af vores produkter inden for håndkøbs- og receptpligtig medicin. Ydermere har teamet en væsentlig opgave i håndtering og registrering af master data i ERP-systemet Axapta, samt i at indhente dokumentation fra kontrakttagere i form af virksomhedsgodkendelser og kvalitetsdokumenter. QA-Release Support team har en afgørende rolle i forbindelse med udarbejdelse af dokumentation i relation til frigivelse af varer, afvigelseshåndtering samt sikrer vedligeholdelse af kvalitetssystemer og kvalitetshåndbogen indenfor GMP. Om dig Som Team Manager for QA-Release Support team er det din primære opgave at lede og fordele arbejdet samtidigt med, at du selv er en del af den daglige drift. Du skal også udvikle og optimere teamet samt jeres arbejdsprocesser efter Lean principper og sikre at der ikke gås på kompromis med kvaliteten. Du kommer til at samarbejde med Team Managers fra andre QA afdelinger samt have et tæt samarbejde med andre afdelinger som eksempelvis regulatorisk og indkøb. Du vil indgå i QA ledergruppen, der består af ca. 8 personer. Vi forventer, at du er/har: Faglært eller bachelor indenfor processer, produktion eller logistisk +5 års erfaring teamledelse af faglært - gerne fra reguleret branche Solide kommunikations- og formidlingsevner - primært Dansk Struktureret, proces-tænkende, udviklende og positivt mindset God til at skabe relationer ”brobygger” Stakeholder samt bred kontaktflade håndteringsevner Service-minded og lyttende tilgang ”spillende træner” IT-kendskab - gerne Axapta Om Orifarm Orifarm er den største parallelimportør af lægemidler i Europa og den største udbyder af lægemidler i Danmark. Orifarm blev grundlagt i 1994 af Birgitte og Hans Bøgh-Sørensen, og gennem vores to overordnede forretningsområder, parallelimporterede lægemidler og generika, skaber vi konkurrence og store besparelser for samfundet og forbrugerne. Entreprenørånden er stadig en stor del af virksomheden, da vi hele tiden søger efter nye muligheder og forretningsområder at investere i. Vores mission er at skabe mærkbare besparelser for samfundet via parallelimporterede og generiske lægemidler og at give forbrugerne mere sundhed for pengene. Vi bestræber os på at indfri dette mål, og insisterer samtidigt på at være gode kolleger, udvikle os sammen, hjælpes ad og lære nyt. I 2020 stod Orifarm over for sin hidtil største milepæl med et stort opkøb, inden for det generiske område. Et opkøb der bidrager kraftigt til Orifarms videre vækst og opnåelse af vores visioner. Om processen Du er altid velkommen til at kontakte Head of Recruitment Ida Wenger-Parving på tlf. 2633 4301 eller Lise Sønnersgaard Talent manager på tlf. 6098 1303, eller søge stillingen inden den 25.06.2021 direkte via vores hjemmeside www.pharmarelations.com At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, colour, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-04-28

SSI Diagnostica

Clinical Trial Manager In-vitro Diagnostik

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Clinical Trial Manager In-vitro Diagnostik
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. We are currently partnering with SSI Diagnostica and their R&D unit. They are looking to recruit a Clinical Trial Manager-IVD to join their internal R&D team in Copenhagen, Denmark. The position is office based, full-time and up to at least 30 days travel must be except. As a Clinical Trial Manager, you will be responsible for the establishment of relevant network among external hospital KOL & PI, including WHO and FIND network. Writing the clinical protocols and ensure site relevance, is of essence. You have knowledge from medical devices and are familiar with design control, verification, and validation phase. Support and share knowledge with the commercial department e.g. tender input, educational workshops for distribution partners and direct customers. You are happy to make written reports, documentation and analyze clinical data for commercial purpose. Your participation and active involvement in R&D activities and projects is very important, hence this position gives you a great opportunity to influence the R&D department and SSI Diagnostics future Key responsibilities include: Establish relevant KOL network at interested global site Facilitate workshops and educational seminars on products. Ensure Clinical trials and monitoring. Ensure the correct documentation, write report and medical writing. Ensure compliance to IVDR (EU-legislation 2017/746), ISO 13485 Participate in Post market surveillance activities Requirements: Master degree within Sciences +5 years’ experience with Clinical trial International- preferable in-vitro diagnostic Strong communication and presentation skills Stakeholder management and network skills Project leader experience Solid understanding of R&D process Solid understanding of and experience from ISO 13485, cGMP and extra valuable if you have knowledge of IVDR Positive with a can-do attitude Independent but team player Why? SSI Diagnostica, which until 2016 was part of Statens Serum Institut, has in recent years been in a build-up phase, especially in international markets. To further accelerate its growth, SSI Diagnostica have acquiring the American company CTK Biotech, which, among other things, has developed one of the world's most accurate COVID-19 antibody tests to date. With the acquisition, SSI Diagnostica strengthens its global production and distribution and gains access to a wide range of new markets around the world. Clinical studies within in-vitro diagnostics is a requirement according to IVDR and can furthermore be the gamechanger for winning the sales. SSI Diagnostica will be responsible of Clinical studies across the SSI Diagnostica Group (SSI Diagnostica and CTK Biotech). How? For further information do reach out to Head of recruitment Ida Wenger- Parving on +45 2633 4301 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-04-19

Bioneer

Business Development Manager Small Molecules

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Business Development Manager Small Molecules
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. We are currently partnering with Bioneer and their Small Molecules/Peptides Unit. They are looking to recruit a Business Development Manager to join their internal team in Hørsholm and Copenhagen, Denmark. As a Business Development Manager Small Molecules/Peptides, you will be responsible for mastering the scientific sales, the ability to effectively convert prospects to customers. You will be joining a growing organization that excels in delivering customized research service solutions primarily to the pharmaceutical industry within early drug discovery and development. You will, as part of an experienced commercial team, be working closely with colleagues in Business Development and Marketing as well as cross-functionally with highly skilled R&D colleagues. Reporting to the Chief Business Officer, you will be responsible for managing all commercial activities related to Bioneer’s small molecule and peptide business area. Importantly, you will be responsible for managing several existing long-term strategic customer partnerships and forging new ones across Bioneer business areas. Customized research services typically include physicochemical characterization and formulation of drug molecules, and performance testing of drugs in different in vitro models. Client projects often combine the capabilities and strengths of the Bioneer groups at University of Copenhagen and in Hørsholm. This is a full-time position offering the flexibility of working remotely. Two-three days per week at Bioneer should be expected split evenly between the Copenhagen and Hørsholm locations as travel permits. Key responsibilities include: Grow sales and drive BD for the Small Molecule/Peptide business area to achieve company goals Contribute to, implement, and report on Sales/Marketing plan for the business area Identify, qualify, and prospect new leads Serve as key point person and Sales/BD manager for selected strategic partners across Bioneer business areas Network and engage with existing customers, new prospects and industry networks Generate proposals in close collaboration with R&D project leaders Negotiate and close contract research service contracts Qualifications: Relevant education in pharmaceutical sciences or related areas with a good understanding of pharmaceutical drug development processes from the industry B2B Sales and/or Business Development work experience from the life science industry – ideally accustomed to working with strategic partners Proven track record in converting leads to negotiated deals and in growing sales Accustomed to working independently and in cross-functional teams - and to solicit input from key stakeholders Excellent communications skills writing, speaking and presenting in English required Strong networking and customer engagement skills Position requires both domestic and international travel (approx. 25%) Why? Bioneer is a specialty-CRO operating as a strategic research partner to biotech and pharmaceutical companies and collaborators engaged in discovery and early development of biologics and small molecule therapeutics. We offer clients access to highly skilled scientists and advanced technologies. We excel in delivering customized research service solutions for advanced disease modelling, protein manufacturing and early drug development globally, while we continuously aim to improve our research solutions at the interface between biology and other sciences. www.bioneer.dk How? For further information do reach out to Recruitment Manager Lise Sønnersgaard on +45 60981303 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, colour, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-04-19

Bioneer

Business Development Manager Recombinant Proteins

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Business Development Manager Recombinant Proteins
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. We are currently partnering with Bioneer and their Recombinant Protein Unit. They are looking to recruit a Business Development Manager to join their team in Hørsholm, Denmark. As a Business Development Manager Recombinant Proteins, you will be responsible for mastering the scientific sales, the ability to effectively convert prospects to customers. You will be joining a growing organization that excels in delivering customized research service solutions primarily to the pharmaceutical industry to which Bioneer operates as a strategic R&D partner in early drug discovery and development. You will, as part of an experienced commercial team, be working closely with colleagues in Sales and Business Development, Marketing as well as cross-functionally with highly skilled scientific colleagues. Reporting to the Chief Business Officer, you will be responsible for managing all commercial activities related to Bioneer’s recombinant proteins business area. Importantly, you will be responsible for managing several existing long-term strategic customer partnerships and forging new ones across Bioneer’s business areas. This is a full-time position offering the flexibility of working remotely. Two-three days per week at Bioneer should be expected split evenly between the Copenhagen and Hørsholm locations as travel permits. Key responsibilities include: Grow sales and drive BD for the Recombinant Protein business area to achieve company goals Contribute to, implement, and report on Sales/Marketing plan for the business area Identify, qualify, and prospect new leads Serve as key point person and Sales/BD manager for selected strategic partners across Bioneer business areas Network and engage with existing customers, new prospects and industry networks Generate proposals in close collaboration with R&D project leaders Negotiate and close contract research service contracts Qualifications: Relevant education in recombinant protein field with a good understanding of the discipline of bacterial/mammalian protein expression and production B2B Sales and/or Business Development experience – ideally accustomed to working with strategic partners Proven track record in converting leads to negotiated deals and in growing sales Work experience with recombinant protein expression and production – preferred if experience from the CRO/CMO or pharmaceutical industry Accustomed to working independently and in cross-functional teams – and to solicit input from key stakeholders Excellent communication skills writing, speaking and presenting in English required Strong networking and customer engagement skills Position requires both domestic and international travel Ability to work remotely. Minimum two days per week at Bioneer in Hørsholm (DK) to be expected Why? Bioneer is a specialty-CRO operating as a strategic research partner to biotech and pharmaceutical companies and collaborators engaged in discovery and early development of biologics and small molecule therapeutics. We offer clients access to highly skilled scientists and advanced technologies. We excel in delivering customized research service solutions for advanced disease modelling, protein manufacturing and early drug development globally, while we continuously aim to improve our research solutions at the interface between biology and other sciences. www.bioneer.dk How? For further information do reach out to Recruitment Manager Lise Sønnersgaard on +45 60981303 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, colour, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-03-25

Novartis

Medical Manager focused on pre-launch

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Medical Manager focused on pre-launch
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. We are currently partnering with Novartis - an innovative and prestigious Pharmaceutical company looking to recruit a Medical Manager who will be responsible for driving the launch preparations for new products to join their team in Denmark. The position is field based and full time job. As a Medical Mgr. focused on pre-launch you will be responsible to lead the account work and planning during the pre-launch phase and involve suitable cross-functional stakeholders to deliver "state of the art" Novartis launches within the cardiovascular, renal and metabolic area or neuroscience area. Agility to move therapeutic area based on Novartis future priorities is required. You will also be the driver for account relevant medical scientific projects to meet local needs, acting in collaboration with relevant Medical Leader, Market Access, Nordic RWE team, Medical Information, Sales and Marketing as well as the Nordic R&D/pipeline team. You will also be the driver for account relevant medical scientific projects to meet local needs, acting in collaboration with relevant Medical Leader, Market Access, Nordic RWE team, Medical Information, Sales and Marketing as well as NORPIST. Key responsibilities include: Co-create the local launch strategy together with relevant functions Driving the launch preparations for the relevant accounts within the Therapeutic Area Leads medical scientific projects to meet local needs and acts in collaboration with Medical Leader, Market Access, Nordic RWE team, Medical information, Sales and Marketing Builds positive relationships with the respective accounts, such as Guideline Committees, Drug formulary Committees and National recommendation groups. Secures an in-depth understanding of our data in the context of the therapeutic area. Collects impactful insights and finds opportunities to innovate and digitalize. Requirements: Solid scientific background with a minimum of MSc Degree In-depth and holistic understanding of the health care system, stakeholder system, needs, and patient journeys. knowledge of industry, competitors, relevant market dynamics Appetite for new technologies, digital savvy Emotional intelligence, self-aware Great teammate and efficient collaborator, able to build positive relationships concise communication & presentation skills, knows how to summarize and communicate the key points and business case to others Fluency in Danish and English Holds a driving license Why? Novartis embraces diversity, equal opportunity and inclusioin. We are committed to building diverse teams. We strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. How? For further information do reach out to Medical Talent Manager Louise Brinking on louise.brinking@pharmarelations.dk or telephone number 53769570 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-03-16

PharmaRelations ApS

Senior Regulatory Affairs konsulent indenfor medicinsk udstyr

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Senior Regulatory Affairs konsulent indenfor medicinsk udstyr
Nu er det tid til det næste trin i udviklingen af PharmaRelations i Danmark - måske også i din? Hos PharmaRelations Danmark har vi stor succes med at levere konsulentløsninger inden for det område, som vi kalder ”Regulatory Services”. Det dækker blandt andet områderne Regulatory Affairs (RA) og Quality Assurance (QA) hos en bred vifte af Life Science kunder. Vi yder fleksible løsninger på timebasis, enten som ad hoc eller på projektbasis. Siden vi åbnede afdelingen for Regulatory Services i marts 2020, har vi kun oplevet stor fremgang. I dag tæller afdelingen 4 dygtige medarbejdere og vi har behov for flere i takt med den stigende efterspørgsel. Vi leder efter dig med en iværksætterånd, der vil være med til at udvide vores område indenfor medicinsk udstyr. Du vil arbejde med kunder og projekter/produkter, hvor behovet for vejledning i form af erfaring, beslutsomhed og evnen til operationel implementering af høj kvalitet er yderst vigtigt. Du vil derfor arbejde tæt sammen med andre kollegaer, både lokalt i Danmark, men også tværfagligt med andet personale i PharmaRelations Nordic. Du har solid erfaring og kompetencer med medicinsk udstyr inden for Regulatory Affairs /Quality Assurance, og det er kun et plus hvis du også har erfaring med Pharma. Du har nu et ønske om at prøve noget nyt, at gøre en forskel for nuværende og kommende kunder. Du får mulighed for netop at bruge dine erfaringer, kombineret med din lyst til at tage ejerskab for dine egne kunder, hvor din succes er fuldstændig transparent. Hvem er du? Du er farmaceut, ingeniør eller tilsvarende, har solid erfaring med medicinsk udstyr fra rolle i en RA/QAstilling. Hvis du tillige allerede har erfaring som konsulent, så er det et stort plus! For at lykkes med rollen er det vigtigt, at du er en holdspiller med en udadvendt og udpræget rådgivende personlighed og er interesseret i at opbygge/udvikle noget nyt. Du er dygtig til at skabe og opretholde relationer og kan afholde møder på en professionel måde. Du inspirerer andre gennem engagement og passion for dit arbejde. Vi tror, at du deler vores værdier, såsom samarbejde, mod og lyst til forandring. Vi tilbyder Mulighed for bredt at bruge din nuværende erfaring og samtidig lære nyt i hverdag præget af afveksling og nye udfordringer, uden at miste fokus på din egen fortsatte udvikling. Hos os arbejder du selvstændigt, men med tæt kontakt til dine kolleger. Du vil få stor indflydelse på egen arbejdsdag, opgaveløsning og afdelingens videre udvikling. Tonen er uformel og præget af en løsningsorienteret ”can-do” attitude kombineret med godt humør. Som udgangspunkt vil du få din daglige arbejdsplads på PharmaRelations danske kontor i Virum, men der er mulighed for fleksibilitet i forhold til at arbejde hjemmefra. Stillingen indebærer mindre rejseaktivitet, primært i Sverige. Du rapporterer til den danske Head of QA/RA. Lyder det interessant? Du skal være velkommen til at sende din ansøgning og CV via hjemmesiden www.pharmarelations.dk. Ansøgninger behandles løbende. For mere information kontakt den ansvarlige hos PharmaRelations, Lisbeth Thyregod på lisbeth.thyregod@pharmarelations.dk eller telefon +45 41308660. Ansøg stillingen her: www.pharmarelations.dk Hvem er vi? PharmaRelations er markedsførende i Norden indenfor Talent Services i Life Science Industrien og har kontorer i alle 4 nordiske lande, hvilket sikrer tilstedeværelse og lokal tilknytning uanset geografi. Vi er pt. ca. 160 medarbejdere indenfor både rekruttering og konsulentydelser. Desuden løser vi større og mindre opgaver indenfor Regulatory Services (RA/QA) i vores team af interne konsulenter. PharmaRelations i Danmark og Sverige er certificeret ’Great Place to Work’. Se mere her.

2021-03-15

PharmaRelations ApS

Head of Commercial Danmark

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Head of Commercial Danmark
PharmaRelations er nordisk markedsleder inden for Talent Services til Life Science. Vi leverer et højt niveau af ekspertise gennem vores interim konsulentydelser, rekrutteringer og RA/QA Services til vores kunder. Vi skaber merværdi for vores kunder samt faglig udvikling og karrieremuligheder for vores medarbejdere. PharmaRelations’ kundebase er indenfor: Pharma, Medtech, Biotech, Animal Health, kosttilskud, foodtech og dental. Vi ekspanderer i Danmark! PharmaRelations blev grundlagt i Stockholm i 1997 og er velkendt i Norden. I 2013 åbnede vi det finske kontor i Helsinki, og i 2016 åbnede vi datterselskabet i Danmark. I januar 2018 afsluttede vi den nordiske opsætning ved at åbne vores Oslo-kontor i Norge. Hos PharmaRelations i Danmark har vi haft stor succes med at finde og levere opgaver. De første 5 år har været fantastiske, og for at imødekomme de øgede forventninger fra os selv, vores kunder og potentielle kandidater udvider vi nu endnu en gang inden for forretningsområdet Commercial Interim Services. Vi har brug for at øge kapaciteten i Danmark med mere salgskraft samt et solidt Life Science-netværk og viden inden for det kommercielle område. Vi søger derfor nu en kommerciel og business-minded ”Head of Commercial Interim, Danmark”. Om stillingen og udfordringen PharmaRelations vokser hurtigt i Danmark. På grund af de flere og øgede krav fra vores kunder, har vi brug for dig til at udvide den kommercielle forretning. Som den nye chef for det kommercielle område, vil du finde nye forretningsmuligheder og nye talenter samt levere de forventede kvalitetsløsninger til både nye og eksisterende kunder. Du får ansvaret for dine egne konsulenter og sørge for, at de leverer tjenester af høj kvalitet, samt at de udvikler sig. Du vil arbejde tværfunktionelt med kollegaer i PharmaRelations Nordic. Du rapporterer til den danske Country Manager. Stillingen er baseret i Virum, og rejser i Norden kan forekomme, når det igen bliver muligt. Hvem er du? Du har en relevant akademisk grad og solid erfaring (+10 år) fra det kommercielle område i den danske Life Science industri. Du har arbejdet med salg, marketing og har været leder. For at få succes i denne rolle er det vigtigt, at du har et stort og bredt netværk i den danske Life Science industri, gerne fra både pharma og medtech. Du har en udadvendt personlighed, erfaring fra ansættelser og en generel interesse i at drive forretning. Med andre ord skal du kunne åbne døre, skabe forretningsmuligheder og sælge vores kommercielle konsulent-tjenester! Du har fremragende mundtlige og skriftlige færdigheder på dansk såvel som engelsk, er dygtig til at skabe relationer og i stand til at arrangere og afholde møder med kunder på en professionel måde. Du er en holdspiller, der finder det vigtigt at dele dine ideer og erfaringer med dine kolleger for at udvikle virksomheden og forretningen. Du inspirerer andre gennem dit engagement og passion for dit arbejde. Interesseret? Hvis du har spørgsmål til stillingen eller vil høre mere, så kontakt Country Manager Danmark, Kim Raabymagle: kim.raabymagle@pharmarelations.dk eller telefon 5119 9197. Ansøg her:

2021-03-10

BK medical

Senior Usability Engineer

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Senior Usability Engineer
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. We are currently partnering with BK medical an innovative ultrasound medical device company looking to recruit a Senior Usability Engineer to join their internal team in Copenhagen. As a Senior Usability Engineer (UE), you will be responsible for the development of the area, and ensure the standards within usability engineering from testing, documentation, and risk management. You have solid understanding of the regulatory requirements, and upcoming MDR. You can work in a cross functional setting, in a profound engineering setting and dynamic environment, where your expertise within UE is crucial. The position requires sound hands-on experience with Usability engineering and preferable project skills from R&D. You will be the go-to -person and assist in putting structure and processes up and ensure the integration of UE in design control and risk management. You will be the owner of the UE file. Key responsibilities include: The Senior usability Engineer for BK medical will be a vital person within the team of three UX´er working in close cooperation with RA, Marketing and R&D. You will proactively come up with ideas on how UE can be integrated as a value adding part of product development. You thrive with responsibility and have the courage to implement and influence processes to the better. Taking on the task as Senior Usability engineer require not only a high level of engineering and technical understanding, but also a good portion of social skills and humour, - it should not be the first time you work with complex innovative products. Requirements: Master’s or bachelor’s degree in engineering or related Solid experience with usability engineering including documentation, testing, risk management, UE file etc. Good understanding of R&D processes from medical devices. Experience with IEC62366-1:2015, FDA guidance for human factors(2016), and ISO:14971:2019 4-6 years’ experience from similar role preferable MD Detail orienteered and structured Driven and positive personality Use to work in an international environment Why? BK medical has a unique technology within ultrasound and few competitors in the market.Driven by an expansive strategy BK medical is expanding into new and exciting business areas using the newest technologies – from AI, Robotics and machine learning. BK medical has a global footprint with 650 employees in USA and close to 200 employees in DK - representing the full value chain- from Development – Production and sales. How? For further information do reach out to Head of Recruitment Ida Wenger-Parving on 2633 4301 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-03-05

PharmaRelations ApS

Quality Assurance Associate

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Quality Assurance Associate
PharmaRelations søger nu en Quality Assurance Associate til en konsulentopgave hos en af vores kunder i lægemiddelindustrien, med opstart ASAP. Den helt rette kandidat har arbejdet med kvalitet i et par år i den farmaceutiske industri med en dokumenteret track record. Du kan også være nyuddannet, hvor du har haft et studiejob med egne ansvarsområder indenfor QA, så du har erfaring indenfor området. Du har passion for dit arbejde, er god til planlægning, struktureret samt er resultatorienteret. Den person, vi søger, skal formå at skabe tillid internt i organisationen gennem rigtigt gode kommunikationsfærdigheder og sans for kvalitet i arbejdet. Som QA Associate vil du få base på vores kundes kontor i København. Du bliver en vigtig spiller i kvalitetssikringsteamet med fokus på at sikre overholdelse af eksterne og interne krav vedrørende GxP. Du vil arbejde tæt sammen med og yde støtte til de kvalitetsansvarlige (QP/RP) i forskellige kvalitetsrelaterede spørgsmål og interagere med en bred vifte af interne og eksterne interessenter. Stillingen Oprettelse og vedligeholdelse af procedurer og undervisningsmaterialer i kvalitetsstyringssystemet (QMS) vedrørende kvalitets-/GxP-området. Håndtering af opgaver eksempelvis i forbindelse med afvigelser, CAPA'er, tilbagekaldelser, destruktion, risikostyring, selvinspektioner og distributørstyring. Profil "Quality Mindset". Master of Science in Pharmacy er et plus. Erfaring fra en position i den farmaceutiske industri, ideelt med fokus på kvalitet. Gode kommunikationsegenskaber, god til at begå dig i en organisation med mange interessenter. Flydende i dansk og engelsk, både skrift og tale. Evne til at arbejde i et team, der dækker flere lande. Med PharmaRelations som arbejdsgiver indgår du i et inspirerende og engageret konsulentteam, hvor du som medarbejder får gode muligheder for at udvikle dig. PharmaRelations tilbyder dig samtidig et selvstændigt og stimulerende arbejde i et firma med høje ambitioner, og et klart fokus på vækst og resultater. Vi tilbyder et arbejdsklima baseret på engagement og korte beslutningsveje. Høj kvalitet i leverancen til vores kunde er nøglen til vores fælles succes! Lyder det interessant? Ansøgninger behandles løbende. For mere information kontakt den ansvarlige hos PharmaRelations Louise Brinking på 53 76 95 70 eller Louise.brinking@pharmarelations.dk Du søger stillingen hér:

2021-03-01

PharmaRelations ApS

Value & Access Manager

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Value & Access Manager
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. We are currently partnering with a innovative, leading pharmaceutical company looking to recruit a Value and Access Manager to join their internal team in Ørestaden, Copenhagen. The position is home based and full time. As a Value and Access Manager, you will be responsible for the oversight of getting new launches well through HTA processes (e.g. with the Medicine Council and the Danish Drug Reimbursement Committee) Key responsibilities include: Identifying who are the main external stakeholders for a given product Active in having dialogue with payers on both National as well as Regional level Being the company personalization towards Regional/National customers Collaborate with clinical pharmacologist on Early Warning Is involved in assessing our pipeline in close collaboration with Medical colleagues Dialogue with Head quarter across Medical and Market Access, taking part of a core modelling team when requested Requirements: Knowledge of reimbursement processes and commercial principles Proven ability to develop trust based relationships with key regional stakeholders Knowledge of patient and customer trends and insights Knowledge of unmet medical needs for patients and customers Knowledge of Healthcare industry and external trends. Assessing impact of changes of the HCS Proactively creating value with customers, Healthcare providers, patients and policy makers A strong scientific background and solid experience with HTA processes in Denmark, preferrably from the 'other side of the table' Fluent in Danish and English both verbal and written Why? Our customer is facing plenty of new launches/new product indication in the coming years. Come and join them for an exciting journey. We can assure you will work with drugs that really will make an impact on people's life and improve their lives. How? For further information do reach out to Recruitment manager Lise Sønnersgaard, PharmaRelations either on telephone +45 60981303 or by e-mail lise.sonnersgaard@pharmarelations.dk. You can apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-03-01

PharmaRelations ApS

HEOR Manager

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HEOR Manager
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders. We are currently partnering with a innovative, leading pharmaceutical company looking to recruit a HEOR Manager to join their internal team in Ørestaden, København. The position is office based and full time. As a HEOR Manager, you will be responsible for the oversight of the National Strategies for HEOR, product listings, payer collaboration, Pricing strategy and development of negotiation strategies in collaboration with the Health Policy and Access Team. Key responsibilities include: Implements stategies on country level for listing and contract renewals Interprets payer research to develop explicit and implicit needs of payers Develop optimal brand pricing, market positioning and stateholder influence strategies based on in depth payer environment knowledge Develops negotiation strategies in collaboration with the Health Policy and/or Access Team Takes part in several cross functional teams and the Nordic team of Health Economists Requirements: Health Economist by education Understanding of National Health Care, regulatory environment of drug P&R and listing processes Proven deep understanding og HEOR research and methodologies Stron negotiation and analytical skills Experience as a Health Economist on the payer side would be an advantage Fluent in Dansh and English both verbal and in written A person with strong drive and passion for HEOR Why? Our customer is facing plenty of new launches/new product indication in the coming years. Come and join them for an exciting journey. We can assure you will work with drugs that really will make an impact on people's life and improve their lives. How? For further information do reach out to Recruitment manager Lise Sønnersgaard, PharmaRelations either on telephone +45 60981303 or by e-mail lise.sonnersgaard@pharmarelations.dk. You can apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.

2021-02-05

PharmaRelations AB

CMC Consultants

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CMC Consultants
PharmaRelations is a Swedish owned and leading company that provides qualified interim services and recruitment within Life Science in the Nordics. We have a passion for growing and developing people and companies. The culture of ‘PR’ is based on our values developed by our staff. There is an entrepreneurial spirit here, we have high ambitions with a clear focus on growth and results. At the same time, we have a warm and unpretentious work climate based on participation and short decision-making paths. PharmaRelations is growing and we have a great demand for consulting services. We are currently looking for a senior CMC consultant and a junior to mid-level experienced CMC consultant located in Sweden or Denmark. Your professional qualifications Senior Regulatory CMC – consultant You have a university degree in science, preferably a doctor’s degree, with 10+ years of experience from the pharmaceutical industry within CMC (Chemistry, Manufacturing & Control) for pharmaceuticals and/or biologic products and are used to planning, setting up and running your work independently. The requirements for this role is writing and reviewing module 3 sections of drug substance and drug product for IND/IMPD/MAA/BLA submissions, writing and reviewing CMC development reports consisting of e.g. process development, analytical and formulation development, managing method development and analytical validation of e.g. HPLC methods, cGE and bioassays, managing process validation activities of drug product manufacturing process, evaluating drug substance and drug product stability data and prepare justification of specification limits of drug substance and drug product and writing quality documents/SOPs. You will be participating in advisory meetings and experience from authority is therefore an advantage. You are fluent in English, both in writing and verbally. Preferably also fluent in Swedish and/or Danish. You have a passion for your work, are good at seeing the big picture and prioritizing. The person we are looking for must have the ability to establish confidence in our client and have very good communication skills. CMC Regulatory – consultant You have a university degree in science, with at least 3-5 years of experience from the pharmaceutical industry within CMC. In this role, you will be CMC responsible in product development projects and independently and in collaboration with others in the team run and coordinate projects and investigations. This can also mean compiling CMC documentation in e-CTD format and handling both Module 2 & 3 documents in close collaboration with Subject Matter Experts. You will also need to compile formulation studies and physicochemical experiments and analytics, to write and review guiding instructions and quality documentation in the field. You should therefore be able to critically review, interpret and write documents, both regulatory and scientific. You are fluent in English, both in writing and verbally. Preferably also fluent in Swedish and/or Danish. Wat do we offer you We offer a workplace were your contribution is important and visible as we all take responsibility for our own development as well as PharmaRelations. Within our company you have great opportunities to develop yourself by different tasks and assignments over time. Your application Are you who we are looking for and do you have an action-oriented personality with a passion to grow, together with colleagues in a flexible work environment? Show courage and be active to apply as applications are processed continuously. Fore more information about the assignments, please contact: Shiva Hobbi Nowzari Consultant Manager, Medical Interim Services Sweden +46 70-165 22 64, email: shiva.nowzari@pharmarelations.se or Louise Brinking Medical Talent Manager Denmark +45 5376 9570, email: louise.brinking@pharmarelations.dk Due to GDPR we cannot receive any applications by email, so please submit your CV at www.pharmarelations.se

2021-01-27

MedTrace Pharma A/S

Head of Technical Support - Global

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Head of Technical Support - Global
At MedTrace you will be a valued member of the team and take part in our exciting journey of bringing our innovative soft and hardware solution for heart patient diagnostics to market. The technology is ground-breaking and is already now drawing international accreditation. MedTrace’s technology platform is a combination of an automated hardware system that is able to produce, dose and inject 15O-water, a very short-lived radioactive version of regular water and a software solution that makes the clinician able to draw conclusions about blood flow. The technique has potential for use in other organs and for diagnostic use in other diseases. MedTrace has offices in Lyngby, Denmark and affiliates in Boston and Uppsala. The company favours cross functional teamwork and hiring employees with diverse backgrounds. The company language is English. In MedTrace, all members are valued, we are all very dedicated and ambitious in reaching our common goals. Every day presents itself with plenty of exciting tasks, but we are high spirited with a good sense of HUMOR. The atmosphere is informal, and everybody in the team is heard. Our values include trust in each other, respect for people, responsibility, and dedication. To become a success at MedTrace it is important to have an entrepreneurial mindset with a pragmatic approach to manoeuvre in a young organisation. The targeted markets are Europe, the US and later on Japan. The position as Head of Technical Service - Global The newly established position as Head of Technical Service at MedTrace, is vital for MedTrace further development and installation of its technology in hospitals on a global scale. You are eager to create and establish the new function and has previous experience from service, maintenance, and installations of technical and complex devices – preferable within hospitals or GxP industries. You get highly motivated by servicing customers, using your technical knowledge to install MedTrace´s technology while documenting and ensuring the quality. Writing guidelines and user and service manuals are part of the job, which you see as positive and productive. You will be in contact with end user within the field, and actively give inputs to various stakeholders in MedTrace, - from Business development, QA/RA to Usability Engineering etc., and you will be participating in advancing the technical solution even further by participating in the continuous product development. Hence your have a great interest in growing MedTrace together with its current and future employees. MedTrace is “on the move” and as a development stage company with a revolutionizing technology,not all procedures, manuals or processes are currently in place. You see this as a benefit, and an opportunity for you to put your fingerprint on Medtrace Technical support and implement best practices. Profile Your key responsibilities will be: Establish the customer facing part of MedTrace’s technical service. This includes but not limited to; installation, Service and support, annual maintenance and disassembly of hardware at customer sites Development of the Technical Support function, at a later stage employ team members for Technical Support function Responsible for the collaboration cross functional works from the Technical Support team Responsible for feeding back to the COO and participate in the product development team Solid experience from a Technical Support function in an entrepreneurial environment You have a very hands on engineering or technical background, and have worked with service and installations of complex equipment before, - preferable medical device or production ( GxP). Visiting hospitals or bigger plant sites is part of your past or current work experience. Travelling in Europe as well as USA and later Japan will be a key part of your job. You may expect 50-60 days per year. Other qualifications: You are experienced in cross functional collaborations and project management participation You speak and write English fluently and possess prominent IT skills in MS Office package You are strong in oral as well as written communication and possess the ability to work independently Personal profile You are a “doer”. The company pulse is intense, but together we can accomplish almost everything. You want to make a difference and have an impact, and you like to see your input and ideas transformed into action swiftly. As a person you can simplify things, find solutions, and implement changes. You are a responsible individual, with an analytical mindset, and respect the fact that you will be the face of the company when you visit customers. Application For more information, please contact Lise Sønnersgaard, Recruitment manager at PharmaRelations, telephone +45 60981303 or lise.sonnersgaard@pharmarelations.dk. We will evaluate applications on a running basis, but we need your application no later than February the 15th 2021. You can apply here:

2021-01-27

MedTrace Pharma A/S

Head of QA

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Head of QA
At MedTrace you will be a valued member of the team and take part in our exciting journey of bringing our innovative soft and hardware solution for heart patient diagnostics to market. The technology is ground breaking and is already now drawing international accreditation. MedTrace’s technology platform is a combination of an automated hardware system that is able to produce, dose and inject 15O-water, a very short-lived radioactive version of regular water and a software solution that makes the clinician able to draw conclusions about blood flow. The technique has potential for use in other organs and for diagnostic use in other diseases. MedTrace has offices in Lyngby, Denmark and affiliates in Boston and Uppsala. The company favours cross functional teamwork and hiring employees with diverse backgrounds. The company language is English. In MedTrace, all members are valued, we are all very dedicated and ambitious in reaching our common goals. Every day presents itself with plenty of exciting tasks, but we are high spirited with a good sense of HUMOR. The atmosphere is informal, and everybody in the team is heard. Our values include trust in each other, respect for people, responsibility and dedication. To become a success at MedTrace it is important to have an entrepreneurial mindset with a pragmatic approach to manoeuvre in a young organisation. The targeted markets are Europe, the US and later on Japan. The position as Head of QA The position as Head of QA is new at MedTrace. You will get an exciting opportunity to exercise your knowledge within quality assurance in various different technical areas such as medical device, pharmaceuticals, hardware, software, etc.. You will take a leading role in all aspects of the continued work with developing and establishment of the ISO 13485:2016 compliant QMS covering both medical device as well as pharmaceutical manufacturing. As Head of QA your role is to lead the QA-processes towards certification as will be required for the regulatory clearance of MedTrace’s product. You will be stepping into the design and development phase of the MedTrace´s products, so being able to execute on tasks in an efficient manner is key to your success. Your main base of operation will be at head office in Lyngby Copenhagen, and MedTrace is flexible towards working from home. You will be expected to travel as part of the job, but only on an as needed basis to which you will have a large degree of input. Profile Your key responsibilities will be: Setting up and development of the QA function including driving the development and maintenance of the QMS system Drive expectations for quality Perform QA review of design control documentation Select, qualify, and perform Quality Agreements with Suppliers Coordinate and perform Internal Audits Define and document quality procedures Refine processes for Complaint Handling, CAPA and Change ControlWork cross-functionally to ensure compliant QMS across all functions of the company Solid QA Experience from a regulated production/Industrial environment Your background can be diverse (candidate from relevant university education i.e. Cand Scient or Engineer. What is most important is your solid experience from bringing a Medical Device to the market and your experience working on a QMS and being responsible for the QA/QC function. If you also have experience with QMS from Pharmaceutical industry it would be an advantage but not a requirement You thrive in a role where you have operational tasks and you must have the personal traits and the desire to lead others in a team capacity, and have direct reports. Other qualifications: Thorough understanding of ISO 13485, IEC 62304, MDR 2017/745 and 21 CFR 820 Proven track record within a QA role and cross functional collaboration Speaks and writes English fluently and profond IT skills in MS Office package Good understanding of Quality Risk Management Strong in oral as well as written communication capabilities and the ability to work independently You thrive in the innovative environment that a development stage company can offer Personal profile You are a “doer”. The company pulse is intense, but together we can accomplish almost everything. You want to make a difference and have an impact, and you like to see your input and ideas transformed into action swiftly. As a person you can simplify things, find solutions, and implement changes. You are a responsible person, and you excell in maintaining focus even in busy times. You are a trustworthy person and you value good collaborations. Application For more information, please contact Lise Sønnersgaard, Recruitment manager at PharmaRelations, telephone +45 60981303 or lise.sonnersgaard@pharmarelations.dk. We will evaluate applications on a running basis, but we need your application no later than February the 15th 2021. You can apply here:

2021-01-25

PharmaRelations ApS

Senior Regulatory Affairs konsulent indenfor medicinsk udstyr

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Senior Regulatory Affairs konsulent indenfor medicinsk udstyr
Nu er det tid til det næste trin i udviklingen af PharmaRelations i Danmark - måske også i din? Hos PharmaRelations Danmark har vi stor succes med at levere konsulentløsninger inden for det område, som vi kalder ”Regulatory Services”. Det dækker blandt andet områderne Regulatory Affairs (RA) og Quality Assurance (QA) hos en bred vifte af Life Science kunder. Siden vi åbnede afdelingen for Regulatory Services i marts 2020, har vi kun oplevet stor fremgang. I dag tæller afdelingen 4 dygtige medarbejdere og vi har behov for flere i takt med den stigende efterspørgsel. Vi leder efter dig med en iværksætterånd, der vil være med til at udvide vores område indenfor medicinsk udstyr. Du vil arbejde med kunder og projekter/produkter, hvor behovet for vejledning i form af erfaring, beslutsomhed og evnen til operationel implementering af høj kvalitet er yderst vigtigt. Du vil derfor arbejde tæt sammen med andre kollegaer, både lokalt i Danmark, men også tværfagligt med andet personale i PharmaRelations Nordic. Du har solid erfaring og kompetencer med medicinsk udstyr inden for Regulatory Affairs /Quality Assurance, og det er kun et plus hvis du også har erfaring med Pharma. Du har nu et ønske om at prøve noget nyt, at gøre en forskel for nuværende og kommende kunder. Du får mulighed for netop at bruge dine erfaringer, kombineret med din lyst til at tage ejerskab for dine egne kunder, hvor din succes er fuldstændig transparent. Hvem er du? Du er farmaceut, ingeniør eller tilsvarende, har solid erfaring fra arbejde i en RA/QA-med-tech funktion. Hvis du tillige allerede har erfaring som konsulent, så er det et stort plus! For at lykkes med rollen er det vigtigt, at du er en holdspiller med en udadvendt og udpræget rådgivende personlighed og er interesseret i at opbygge/udvikle noget nyt. Du er dygtig til at skabe og opretholde relationer og kan afholde møder på en professionel måde. Du inspirerer andre gennem engagement og passion for dit arbejde. Vi tror, at du deler vores værdier, såsom samarbejde, mod og lyst til forandring. PharmaRelations har dansk kontor i Virum og du kan forvente mindre rejseaktivitet, primært i Sverige. Du rapporterer til den danske Head of RA/QA Services. Lyder det interessant? Du skal være velkommen til at sende din ansøgning og CV via hjemmesiden www.pharmarelations.dk Ansøgninger behandles løbende. For mere information kontakt den ansvarlige hos PharmaRelations, Lisbeth Thyregod på lisbeth.thyregod@pharmarelations.dk eller telefon +45 41308660. Ansøg stillingen her:

2021-01-21

PharmaRelations ApS

Senior Clinical Research Associate

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Senior Clinical Research Associate
PharmaRelations is a market leading recruitment company, specialising in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across the Nordics. We are specialists in adding value to our clients, with our consultancy services, recruitment of specialists, leaders and outsourcing solutions. We are currently partnering with a prestigious Pharmaceutical company looking to recruit an experienced Senior Clinical Research Associate to join their internal team in Oslo, Norway. The position is home based and full-time. As a Senior Clinical Research Associate, you will be responsible for the oversight of the clinical trials assigned and ensuring that all are conducted, recorded and reported in accordance with the protocol, SOPs, GCP and regulatory requirements. Key responsibilities include: Identifying and assessing new potential Investigators, through ongoing collaborations with internal and external stakeholders. Developing site relationships and recommending sites during the site feasibility and/or site selection process. Conducting pre-study visits and initiations. Conducting monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, company procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable. Performing Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor. While monitoring, demonstrating the ability to use data to assess risks, identify issues and make appropriate decisions. Providing training to sites while serving as a point of contact. Performing site closure activities when all required protocol visits and follow-up are completed Managing multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory. Ensures completeness and quality of data submitted from study sites. Ensures eCRF data is available. Overseeing activities of site personnel over whom there is no direct authority Motivating/influencing the site to meet study objectives, including enrolment and retention goals. Demonstrating flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication methods. Anticipating, identifying and proactively supporting site in resolving issues as they occur. Appropriately documenting and promptly escalating serious or persistent outstanding issues to management and project team. Initiating, recommending, documenting and communicating corrective actions as needed and following up to ensuring corrective/preventive actions based on root cause analysis are implemented. Involvement in Regulatory Compliance audit/inspection process, as needed. Preparing and submitting written reports, both monitoring and administrative. May support equipment calibration and tracking. May support preparation of Study Initiation Visit materials. Senior Level Expectations: Proactively identifying and resolving potential problems at both site and country level. Engaging with Clinical Trial Manager and/or line management to assist in the resolution of more complex issues. Proactively seeking to enhance communication skills with both internal (Global level) and all relevant external parties, while coaching others to do the same. Contributing significantly to study team and coaching site staff to enhance site and hub performance. Serving as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations. May assist line management with conducting monitoring authorizations and ongoing assessments. Requirements: Bachelors or Master degree required. Field of study within life sciences or equivalent. At least 5 years of monitoring experience. Demonstrate leadership skill, mentor and coach capability. Relevant prior Pharma/Biotech Sponsor employment. Experience in the drug discovery/development process. Basic to good knowledge of ICH/GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials. Knowledge and understanding of clinical research processes, regulations and methodology. Organization and time management skills. Ability to build, maintain and strengthen relationships even under pressure. Good verbal and written communication skills (both in English and Norwegian). Why? Joining a highly esteemed Pharmaceutical company and Clinical Research team, where there is room for you to excel, be valued, develop and make a difference. There is rarely an opening within the team, as the team has great leadership, a healthy work-life balance and a strong company culture. And, needless to say, competitive salaries and great benefit packages. How? For further information do reach out to Clinical Talent Manager, Claudia Jørgensen Rankine on claudia.rankine@pharmarelations.dk or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience. Apply for the position here:

2021-01-15

PharmaRelations ApS

Senior Regulatory Affairs konsulent til PharmaRelations Danmark

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Senior Regulatory Affairs konsulent til PharmaRelations Danmark
Nu er det tid til det næste trin i udviklingen af PharmaRelations i Danmark - måske også i din? Hos PharmaRelations Danmark har vi stor succes med at levere konsulentløsninger inden for det område, som vi kalder ”Regulatory Services”. Det dækker blandt andet områderne Regulatory Affairs (RA) og Quality Assurance (QA) hos en bred vifte af Life Science kunder. Siden vi åbnede afdelingen for Regulatory Services i marts 2020, har vi kun oplevet stor fremgang. I dag tæller afdelingen 4 dygtige medarbejdere og vi har behov for flere i takt med den stigende efterspørgsel. Vi leder efter dig med en iværksætterånd, der vil være med til at udvide vores RA/QA-afdeling. Du vil arbejde med kunder og projekter/produkter, hvor behovet for vejledning i form af erfaring, beslutsomhed og evnen til operationel implementering af høj kvalitet er yderst vigtigt. Du vil derfor arbejde tæt sammen med andre kollegaer, både lokalt i Danmark, men også tværfagligt med andet personale i PharmaRelations Nordic. Du har solid erfaring og kompetencer inden for Regulatory Affairs / Quality Assurance indenfor Pharma, og det er kun et plus hvis du også har erfaring med Med-tech. Du har nu et ønske om at prøve noget nyt, at gøre en forskel for nuværende og kommende kunder. Du får mulighed for netop at bruge dine erfaringer, kombineret med din lyst til at tage ejerskab for dine egne kunder, hvor din succes er fuldstændig transparent. Hvem er du? Du er farmaceut eller tilsvarende, har solid erfaring (mindst 10 år) fra arbejde i en RA/QA-funktion hos et moder- og/eller datterselskab i medicinalindustrien. Hvis du tillige allerede har erfaring som konsulent, så er det et stort plus! For at lykkes med rollen er det vigtigt, at du er en holdspiller med en udadvendt og udpræget rådgivende personlighed og er interesseret i at opbygge/udvikle noget nyt. Du er dygtig til at skabe og opretholde relationer, er en dygtig sælger og kan afholde møder på en professionel måde. Du inspirerer andre gennem engagement og passion for dit arbejde. Vi tror, at du deler vores værdier, såsom samarbejde, mod og lyst til forandring. PharmaRelations har dansk kontor i Virum og du kan forvente mindre rejseaktivitet, primært i Sverige. Du rapporterer til den danske Head of RA/QA Services. Lyder det interessant? Du skal være velkommen til at sende din ansøgning og CV via hjemmesiden www.pharmarelations.dk Ansøgninger behandles løbende. For mere information kontakt den ansvarlige hos PharmaRelations, Lisbeth Thyregod på lisbeth.thyregod@pharmarelations.dk eller telefon +45 41308660. Ansøg stillingen her:

2020

2020-12-21

Orifarm

VP Quality Compliance

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VP Quality Compliance
PharmaRelations assisterer Orifarm med en nyoprettet stilling som VP Quality Compliance Orifarm udvider i 2021 deres generiske- og receptpligtige lægemiddelportefølje betragteligt, og vil bl.a. tilføjet to produktionssites til deres organisation. Herudover bliver Orifarms europæiske tilstedeværelse udvidet med en række nye lande. Dette er en gamechanger for Orifarm, som med udvidelsen bliver en mere traditionel producerede lægemiddelvirksomhed. Det forretningsmæssige tilkøb kræver et yderligere og stærkere fokus på Quality compliance hos Orifarm. www.orifarm.com Med reference til Orifarm Groups CEO, vil VP Quality compliance sætte den strategiske retning for koncernens kvalitetsstandarder, samt drive og implementere de nødvendige værktøjer og processer i henhold til kvalitet og compliance niveauet på europæisk plan. Dette gøres i tæt samarbejde med kollegaer i de europæiske lande, lokale myndigheder og produktionsansvarlige samt andre relevante stakeholders. I denne rolle vil du få brug for din brede erfaring indenfor kvalitet og compliance fra Life Sciences branchen, med særligt fokus på GMP & GDP. Du har et særligt godt kendskab til det europæiske marked og det er ikke første gang, du har arbejdet på et strategiske niveau i en lægemiddelproducerende virksomhed. Dine ledelseskompetencer og stil er vel afprøvet, og du formår at involvere medarbejdere og relevante stakeholders. VP Quality compliance vil have 6-8 medarbejdere i direkte reference. Du skal forvente, at rollen forandrer sig over tid i takt med at Orifarm udlever sin ambitiøse vækststrategi. Orifarm er præget af en helt særlig entreprenant og forretningsorienteret kultur, som gennemsyrer virksomhedens måde at træffe beslutninger på, se nye forretningsmuligheder i markeder og agere på disse. Således bliver du en del af en ”fast pace” virksomhed, hvor missionen er at skabe mere sundhed for pengene og besparelser for samfundet og patienterne, gennem salg og produktion af parallelimporterende og generiske lægemidler. Er du den løsningsorienterede, beslutningstagende og forretningsforstående Quality compliance ansvarlig? Så er dette en virksomhed og stilling for dig! Kompetencer & Personlige Egenskaber Cand. sundhedsfaglig el. Ingeniør – gerne med forretningsmæssig overbygning HD el.lign. +7 år erfaring med Quality & compliance – fra GMP-regulerende brancher Solide kommunikations- og formidlingsevner – både dansk og engelsk Strategisk og analytisk tænkende Ambitiøs og løsningsorienteret med fokus på forretningen Relations skabende og ”brobygger” Du er altid velkommen til at kontakte Head of Recruitment Ida Wenger-Parving på tlf. 2633 4301, eller søge stillingen inden den 25.01.2021 hér:

2020-12-02

PharmaRelations ApS

Senior Quality Assurance Konsulent, Danmark

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Senior Quality Assurance Konsulent, Danmark
Senior Quality Assurance Konsulent PharmaRelations søger nu en Senior Quality Assurance Konsulent til en konsulentopgave hos en af vores kunder i lægemiddelindustrien, med tiltrædelse ASAP. Den helt rette kandidat har arbejdet med kvalitet i en årrække i den farmaceutiske industri med en dokumenteret track record. Du har passion for dit arbejde, er god til planlægning, struktureret samt er resultatorienteret. Den person, vi søger, skal formå at skabe tillid internt i organisationen gennem rigtig gode kommunikationsfærdigheder og sans for kvalitet i arbejdet. Du lade dig ikke skræmme af, at det er en virksomhed i kraftig vækst og med dertil hørende travlhed. Som Senior Quality Assurance Konsulent vil du få base på vores kundes kontor i København. Du bliver en vigtig spiller i kvalitetssikringsteamet med fokus på at sikre overholdelse af eksterne og interne krav vedrørende GxP (herunder primært fokus på GCP). Du vil arbejde tæt sammen med og yde støtte til de kvalitetsansvarlige (QP/RP) i forskellige kvalitetsrelaterede spørgsmål og interagere med en bred vifte af interne og eksterne interessenter. Stillingen Klargøring til inspektion i samarbejde med interne funktioner Overvåge GxP regulativer og guidelines. Oprettelse og vedligeholdelse af procedurer og undervisningsmaterialer i kvalitetsstyringssystemet (QMS) vedrørende kvalitetsområdet, f.eks. GCP. Opdatere og vedligeholde SOP´er. Håndtering af opgaver i forbindelse med afvigelser, CAPA'er, tilbagekaldelser, destruktion, risikostyring og selvinspektioner Identificere og bidrage til best practice og proces optimering på tværs af organisationen. Profil "Quality Mindset". Master of Science in Pharmacy er et plus. Erfaring fra lignende stilling(er) i den farmaceutiske industri. Gode kommunikationsegenskaber, god til at begå dig i en organisation med mange interessenter. Flydende i dansk og engelsk, både skrift og tale. Evne til at arbejde i et team, der dækker flere lande. Med PharmaRelations som arbejdsgiver indgår du i et inspirerende og engageret konsulentteam, hvor du som medarbejder får gode muligheder for at udvikle dig. PharmaRelations tilbyder dig samtidig et selvstændigt og stimulerende arbejde i et firma med høje ambitioner, og et klart fokus på vækst og resultater. Vi tilbyder et arbejdsklima baseret på engagement og korte beslutningsveje. Høj kvalitet i leverancen til vores kunde er nøglen til vores fælles succes! Lyder det interessant? Ansøgninger behandles løbende. For mere information kontakt den ansvarlige hos PharmaRelations Louise Brinking på 53769570 eller Louise.brinking@pharmarelations.dk Du søger stillingen hér:

2020-12-02

Macopharma

National Key Account Manager

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National Key Account Manager
Macopharma er et verdensledende innovativt firma indenfor transfusioner og transfusionsudstyr. Firmaet har eksisteret i mere end 40 år. Vores devises og transfusionsudstyr anvendes af blodbanker og hospitalsafdelinger i mere end 80 lande. På verdensplan er der ca. 2250 medarbejdere ansat. Til at styrke salget i Danmark søger PharmaRelations til Macopharmas Skandinaviske team en: National Key Account Manager Du kommer selvstændigt til at varetage salg og information i Danmark af vores produkter til blodbanker samt klinisk kemiske afdelinger på hospitalerne i Danmark. Opgaver Udbygge og fremme kunderelationer Udbygge salg og Macopharmas position på markedet Udvikle og implementere salgsstrategier og -aktiviteter på lokalt plan Selvstændigt kunne udarbejde markedsanalyser, salgsstatistikker, årsbudget, forecast, indsende dokumenter til licitationer m.m. Yde teknisk support til kunden i form af kalibrering, løsning af tekniske spørgsmål og udfordringer Kvalifikationer Relevant faglig baggrund kombineret med mindst 5 års salgserfaring (Bioanalytiker, farmaceut, biokemiker eller lignende). Erfaring fra salg til offentlige hospitaler med dokumenterede gode resultater Erfaring med udarbejdelse af markedsanalyser, salgsstatistikker, årsbudget, forecast m.m. Kommunikerer ubesværet på engelsk såvel mundtligt som skriftligt Personlige egenskaber Serviceorienteret og kundecentreret Innovativ i tankegang, tager aktivt initiativ Analytisk og strategisk tilgang Løsningsorienteret med sans for prioritering af opgaver Entreprenørisk ’mindset’ Behagelig og tillidsvækkende personlighed Stærkt drive og selvmotiverende Macopharma tilbyder En spændende, afvekslende og meget selvstændig dagligdag i et firma i vækst. Du bliver en del af det skandinaviske team, hvor teamspirit, gensidig respekt og støtte er en del af vores dagligdag. For den rette vil der være rigtig gode udviklingsmuligheder i jobbet. Løn efter kvalifikationer. Har du fået lyst til søge jobbet? Du skal være velkommen til at uploade din ansøgning og CV via vores hjemmeside www.pharmarelations.dk. Ansøgninger behandles løbende, sidste frist for ansøgning er den 15. december 2020. For mere information kontakt den ansvarlige hos PharmaRelations, Lise Sønnersgaard på mail: lise.sonnersgaard@pharmarelations.dk. Har du spørgsmål, kan du ringe til Lise på telefon 60981303. NB! CV og ansøgninger modtages ikke på e-mail.

2020-11-25

Visiopharm

Customer Success Professional

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Customer Success Professional
Visiopharm er en ledende spiller indenfor patologisk billeddiagnostik baseret på digital AI (Artificial Intelligence). Visiopharms digitale løsning anvendes af tusindvis af videnskabelige medarbejdere, patologer og specialister på hospitaler, videnskabelige institutioner og i den biofarmaceutiske industri. Til en nyoprettet stilling hos Visiopharm søger PharmaRelations en Customer Success Professional Er du klar til en spændende opgave i et hurtigt voksende team i en innovativ vækstvirksomhed indenfor billeddiagnostik? Så er det måske dig, vi søger. Til vores Clinical Sales-afdeling søger vi en kollega til at koordinere vores indsats, så kunden får en positiv oplevelse omkring leverancen og den øvrige service, vi stiller til rådighed. Du skal assistere vores salgs- og leveringsafdeling med implementering af projekter og undervisning. Din opgave bliver også at have fuldstændigt overblik over vores kontrakter og abonnementsløsninger, samt holde øje med, hvornår licenser skal fornyes med kunden. Du bliver kundens ”garant” for, at problemerne hurtigt bliver identificeret og løst i organisationen. Kvalifikationer: Projektledelseserfaring Minimum 2-3 års erfaring fra hospitalsverdenen eller healthcare-branchen fra en supportfunktion med kundekontakt Erfaring fra arbejde med service- eller supportkontrakter Du mestrer dansk, engelsk, gerne svensk eller andre europæiske sprog Din uddannelsesmæssige baggrund er ikke afgørende, men din erfaring med koordinering, opfølgning, kundeservice samt opbygning og vedligeholdelse af kunderelationer er det, som vi lægger vægt på Personlige kompetencer: Du er en stærk teamplayer med en udtalt struktureret arbejdsform. Du evner også at skabe struktur for de andre i teamet, så vores kunder får en rigtig god oplevelse af en koordineret og veltilrettelagt leverance. Din indsats skal igangsættes samtidig med, at andre parallelle aktiviteter er i gang. Hvis du er procesorienteret, løsningsorienteret og optaget af at yde en god kundeservice er det måske lige dig, vi savner. Hvis du ydermere har indsigt i patologi, så bliver vi rigtig glade. Teamet: Stillingen refererer til Senior Vice President, Global Clinical Sales, Martin Kristensson. Dine kolleger bliver hele vores Clinical Sales Team, primært i Europa. Det kan forventes, at du skal supportere andre teams fra tid til anden, fx med opbygning og implementering af processer for indsendelse af tilbud til licitationer i et nyligt etableret team. Vores team er kendt for at arbejde tæt sammen og fejre vores sejre i fællesskab. Visiopharm tilbyder: En meget spændende, nyoprettet stilling i en innovativ virksomhed i stor vækst. Stillingen har gode udviklingsmuligheder, og vi tilbyder løn efter kvalifikationer, bonus og pension. Visiopharm ligger i Hørsholm nord for København. Ansøgning: Har du fået lyst til at søge jobbet, så søg allerede i dag. Ansøgninger behandles løbende, deadline for ansøgning er onsdag den 2/12 kl. 10.00. For mere information kontakt den ansvarlige hos PharmaRelations, Lise Sønnersgaard på tlf. 60981303 eller på mail lise.sonnersgaard@pharmarelations.dk Visiopharm blev grundlagt i 2001 og er et privatejet firma. Vi arbejder internationalt med over 900 licenser og utallige brugere i mere end 40 lande. Hovedkvarteret ligger i Hørsholm med kontorer i Sverige, Storbritannien, Tyskland og USA. Du kan følge Visiopharm på LinkedIn og Twitter. For flere nyheder kan du besøge Visopharm Newsroom på hjemmesiden www.visiopharm.com/newsroom/

2020-11-17

PharmaRelations ApS

Senior Regulatory Affairs Consultant

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Senior Regulatory Affairs Consultant
Nu er det tid til det næste trin i udviklingen af PharmaRelations i Danmark - måske også i din? Hos PharmaRelations Danmark har vi stor succes med at levere konsulentløsninger inden for det område, som vi kalder ”Regulatory Services”. Det dækker blandt andet områderne Regulatory Affairs (RA) og Quality Assurance (QA) hos en bred vifte af Life Science kunder. Siden vi åbnede afdelingen for Regulatory Services i marts 2020, har vi kun oplevet stor fremgang. I dag tæller afdelingen 4 dygtige medarbejdere og vi har behov for flere i takt med den stigende efterspørgsel. Vi leder efter dig md en iværksætterånd, der vil være med til at udvide vores RA/QA-afdeling. Du vil arbejde med kunder og projekter/produkter, hvor behovet for vejledning i form af erfaring, beslutsomhed og evnen til operationel implementering af høj kvalitet er yderst vigtigt. Du vil derfor arbejde tæt sammen med andre kollegaer, både lokalt i Danmark, men også tværfagligt med andet personale i PharmaRelations Nordic. Du har solid erfaring og kompetencer inden for Regulatory Affairs / Quality Assurance indenfor Pharma, og det er kun et plus hvis du også har erfaring med Med-tech. Du har nu et ønske om at prøve noget nyt, at gøre en forskel for nuværende og kommende kunder. Du får mulighed for netop at bruge dine erfaringer, kombineret med din lyst til at tage ejerskab for dine egne kunder, hvor din succes er fuldstændig transparent. Hvis du ydermere selv kan sælge dine egne projekter og opgaver, så er det en markant fordel! Det stiller store krav til mod, nysgerrighed, åbenhed og ikke mindst købmandskab. Hvem er du? Du er farmaceut eller tilsvarende, har solid erfaring (mindst 10 år) fra arbejde i en RA/QA-funktion hos et moder- og/eller datterselskab i medicinalindustrien. Hvis du også kan agere QP og du tillige allerede har erfaring som konsulent, så er det et stort plus! For at lykkes med rollen er det vigtigt, at du er en holdspiller med en udadvendt og udpræget rådgivende personlighed og er interesseret i at opbygge/udvikle noget nyt. Du er dygtig til at skabe og opretholde relationer, er en dygtig sælger og kan afholde møder på en professionel måde. Du inspirerer andre gennem engagement og passion for dit arbejde. Vi tror, at du deler vores værdier, såsom samarbejde, mod og lyst til forandring. PharmaRelations har dansk kontor i Virum og du kan forvente mindre rejseaktivitet, primært i Sverige. Du rapporterer til den danske Head of RA/QA Services. Lyder det interessant? Du skal være velkommen til at sende din ansøgning og CV via hjemmesiden www.pharmarelations.dk Ansøgninger behandles løbende. For mere information kontakt den ansvarlige hos PharmaRelations, Lisbeth Thyregod på lisbeth.thyregod@pharmarelations.dk eller telefon +45 41308660. Ansøg stillingen her:

2020-10-28

Air Liquide

Business Developer

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Business Developer
Vil du være med til at udvikle vores medicinske gas og homecare forretning i Danmark? Vi søger en Business Developer til opbygning af nye forretningsområder indenfor homecare og medicinske gasser. Air Liquide Healthcare, en del af verdens førende gasselskab Air Liquide, er som en førende spiller på verdensmarkedet inden for home healthcare, ekspert i opfølgning af kroniske sygdomme i hjemmet og leverandør af medicinske gasser. 16.500 Air Liquide Healthcare ansatte supporterer 1.7 millioner patienter hjemme og 15.000 hospitaler og klinikker i mere end 35 lande. Air Liquide Danmark A/S er en del af den globale organisation og arbejder tæt sammen med vores søsterselskaber i de andre nordiske lande. Du vil være en del af den nordiske organisation med fokus på den danske forretning. Stillingen som Business developer er nyoprettet, og du ønsker at bruge din strategiske forretningsforståelse, til at udvikle og implementere nye koncepter til relevante samarbejdspartner og kunder indenfor medicinske gasser. Du er vant til at opbygge relationer indenfor det sundhedsfaglig felt og kan begå dig på flere forskellige taktiske, som operationelle niveauer. Du finder det motiverende at komme med ideer til forretningen, og afprøve disse blandt kunderne. Dette ser du som en del af din arbejdsstil. Således er networking, opsøgende salg, proaktive kundebesøg og afdækning af kundebehov og indsigter en del af din opgave. Du trives med at undervise og benytter dine pædagogiske evner til at formidle og træne i bruge af produkter eller services. Vi forestiller os, at du som person er grundig og struktureret samt, at du vil kunne bidrage til udbudsprocesser, og i det nordisk samarbejde. Har du kendskab til det respiratoriske område er dette en fordel. Ellers tænker vi, at du har nogle af følgende kompetencer og kvalifikationer: Kompetencer & kvalifikationer: Sundhedsfaglig uddannelse – eks. Sygeplejerske Erfaring med løsnings- eller konceptsalg – gerne 3-4 år indenfor Life Sciences Gode kommunikations og præsentations evner Netværker og relations skaber Entreprenant og tænker kreativt med fokus på forretningen Proaktivt og selvdreven Er dette noget for dig, kontakt da PharmaRelations Talent Specialist Louise Brinking mob: 5376 9570 eller Head of Recruitment Ida Wenger-Parving mob: 2633 4301. Du er også velkommen til at søge stillingen inden den 15.11.2020 direkte via vores hjemmeside www.pharmarelations.com.

2019

2019-04-26

Kyowa Kirin

Key Account Manager, Region Hovedstaden og Region Sjælland

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Key Account Manager, Region Hovedstaden og Region Sjælland
Kyowa Kirin er et globalt R&D drevet japansk firma, der arbejder indenfor terapiområderne nefrologi, onkologi, immunologi/astma urologi, endokrinologi samt CNS med pharmaceutiske produkter og biologiske antistoffer. PharmaRelations søger på vegne af Kyowa Kirin en KAM til at varetage salget af smertestillende præparater til praktiserende læger og speciallæger indenfor smertebehandling, palliativ medicin, onkologi, hæmatologi, mv. Du har en dybdegående viden indenfor smerteområdet, og en stor erfaring og viden som KAM fra lignende stillinger med salg til målgruppen. Du er af natur god til at opbygge relationer, er resultatorienteret, struktureret, fleksibel, har et højt drive og trives ved at skulle arbejde selvstændigt og udvikle salget af dine produkter. Kendetegnende for dig, er at du har en høj faglig tilgang til dit område, og at du kan dokumentere dine salgsevner. Fra tidligere job har du viden og erfaring med salgsopgaverne i forbindelse med offentlige udbud og licitationer. Du bliver ansvarlig for: Opnå budgetteret salg og overholde omkostningsbudgettet i dit distrikt Udarbejde budget og salgsforecast i dit distrikt Udarbejde en taktisk action/activity plan for distriktsaktiviteterne Sikre at marketing materiale og alle andre aktiviteter overholder dansk lovgivning, kodeks og etiske regler fra Enli Stillingen er feltbaseret og det forventes, at du kan arbejde fra din hjemadresse, ligesom det også forventes, at du har LIF-uddannelsen (DPA) og kørekort til personbil. Kyowa Kirin tilbyder en attraktiv lønpakke, fri bil, internetopkobling og telefon. Ansøgninger behandles løbende og ligeledes invitation til samtaler. Vi vil gerne modtage din ansøgning senest den 22.maj 2019. Såfremt, du har spørgsmål, er du velkommen til at skrive til Talent Manager Lise Sønnersgaard på lise.sonnersgaard@pharmarelations.dk eller ringe på telefon 60981303.