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2021

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

2021-04-28

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.

2021-04-26

PharmaRelations ApS

Quality Assurance Specialist

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Quality Assurance Specialist
For vores kunde søger vi en Quality assurance Specialist med start snarest. 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. Vi har et fuldt ansvar for end-to-end processer: Fra designkontrol til endelig frigivelse og håndtering af reklamationer. Du vil blive en del af et dynamisk team, der fokuserer på at udvikle kvalitetsstyringssystemet til en dynamisk organisation. Tonen i gruppen er uformel. Profil Dette er en stilling som QA Specialist indenfor kvalitetskontrol og QC Laboratory Management. Du får en fantastisk mulighed for at kombinere din viden om kvalitet inden for forskellige tekniske områder som biokemi, kemi, software, hardware og elektronik. Dine nøgleområder vil være: 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 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, helst i en USDA eller FDA/ISO 13485 medicinsk udstyr reguleret industri. Erfaring med QC-laboratorium og forståelse af princippet i ISO 17025:2015. 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, Medical Talent Manager 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.

2021-04-19

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.

2020-09-25

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 november 2020. Stillingen er tidsbegrænset 12 måneder til udgangen af oktober 2021 og er et barselsvikariat. 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) og dækker det danske marked. 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 12. oktober 2020. For mere information kontakt den ansvarlige hos PharmaRelations, Louise Brinking på + 45 53 76 95 70 eller Louise.brinking@pharmarelations.dk Søg stillingen hér:

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.