Regulatory Coordinator/Writer with Background in Analytical Chemistry

Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger

Bagsværd

Do you have great coordination skills, writing skills and a background in analytical chemistry? Do you feel at home in an ever-changing and high-paced environment with multiple stakeholders? Are you positive, energetic, flexible, and a team player? Then you may be our new colleague. Apply today! The Position We are currently looking for a regulatory coordinator/writer to join the Analytical Support Team which consists of 8 chemists, 2 laboratory technicians, 1 training supporter and 1 manager. The team is responsible for support to chemical analysis, both internally in the department and globally on IFPs QC sites which we help with method-related questions and complex problem solving, as well as training in new analytical methods. Furthermore, the team is responsible for documentation of chemical analytical methods on marketed drug products in the diabetes and obesity area - and for ensuring compliance to pharmacopoeias and external requirements. Our new colleague will be responsible for coordinating tasks from regulatory affairs, Global Contract Manufacturing (GCM) etc. into the team/department and will also be preparing some of this documentation himself/herself. Your main stakeholders will be colleagues in the department, IFP Manufacturing Development, Regulatory Affairs, QA, GCM and IFPs QC sites across the world. A few yearly traveling days might be expected. Qualifications To be considered for this position, you have:
  • A scientific academic degree such as cand. pharm., cand. scient., chemical engineer or similar, and preferably experience from a GMP regulated laboratory.
  • Experience with regulatory documentation and working experience as an analytical chemist on techniques such as HPLC/UPLC is an advantage.
  • Experience with coordination of larger tasks involving multiple stakeholders.
  • Great collaboration skills and enjoy technical writing and preparation of documents, and you thrive in a changing environment with ambitious deadlines.
  • Strong communication skills both in spoken and written English, and you are able to or interested in learning to communicate in Danish.
  • You have a positive mind-set and can keep it in all situations. Furthermore, we expect that you can work independently, are highly motivated and that your positive mind-set will impact your cooperation with the team and external colleagues. About the Department The Analytical Competence Centre is a department in Injectable Finished Products (IFP) Manufacturing Development and consists of 65 employees organised in four teams. We have a central support function in relation to chemical analysis of Novo Nordisk injectable finished products under development, as well as our marketed products – for diabetes and obesity. The department is responsible for validation of analytical methods before clinical phase 3 and for the following transfer of the analytical methods to our QC laboratories across the world. We also support submission of documentation for health authorities globally – and it is among other things the preparation and coordination of these tasks into our team/department that our new colleague will be responsible for. Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. Contact For further information, please contact Kamilla Jørgensen on +45 3075 3560. Deadline 7 May 2023. We will review and interview candidates continually, as we receive the applications. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


    Information og data

    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Bagsværd.

    Jobbet er oprettet på vores service den 13.2.2023, men kan have været deaktiveret og genaktiveret igen.

    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • Øvrige
    • Bagsværd

    Lignende jobs

    • Øvrige i Frederiksberg C

      Fri kontakt
      Se https://www.digitaldisruptionmedia.com/jobs/piccolinepiccolo-sges-snarest
      • Øvrige
      • Frederiksberg C
      Få mere info
    • Restaurant Manager, Restaurant Ansvar at Scandic S...

      Fri kontakt
      Job Description. If you are ambitious, goal-oriented and not afraid to clear habitual thinking off the table, then we believe that you are our new Restaurant Manager for Restaurant Ansvar, Scandic Spectrum. We know that you take responsibility and have peace of mind with the full overview.
      • Øvrige
      • København
      Få mere info
    • Restaurant Manager til Restaurant Ansvar, Scandic ...

      Fri kontakt
      Er du ambitiøs, målrettet og ikke bange for at rydde vanetænkning af bordet, så tror vi på, at du er vores nye Restaurant Manager til Restaurant Ansvar, Scandic Spectrum. Vi ved, at du ta’r ansvar og har ro i maven med det fulde overblik. Du er god til at organisere, købe ind, lede og dele din viden.
      • Øvrige
      • København
      Få mere info
    • Conference Host, fuldtid, Scandic Sluseholmen

      Fri kontakt
      Griber du mulighederne, har overblik og er god til at guide vores gæster, så tror vi på, at du er vores nye Conference Host på Scandic Slusenholmen. Vi ved, at du brænder for at gøre en forskel og har fokus på detaljerne. Og vi ved, at du får tingene til at ske og gerne sætter overliggeren lidt højere for at skabe en succes.
      • Øvrige
      • København
      Få mere info

    Statistik over udbudte jobs som øvrige i Bagsværd

    Herunder ser du udviklingen i udbudte øvrige i Bagsværd over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal øvrige.

    Se flere statistikker her:
    Statistik over udbudte øvrige i Bagsværd over tid

    Dato Alle jobs som øvrige
    6. november 2024 57
    5. november 2024 57
    4. november 2024 53
    3. november 2024 58
    2. november 2024 57
    1. november 2024 56
    31. oktober 2024 64
    30. oktober 2024 50
    29. oktober 2024 49
    28. oktober 2024 47
    27. oktober 2024 53
    26. oktober 2024 53
    25. oktober 2024 54
    24. oktober 2024 51
    23. oktober 2024 51
    22. oktober 2024 49
    21. oktober 2024 50
    20. oktober 2024 55
    19. oktober 2024 55
    18. oktober 2024 53
    17. oktober 2024 49
    16. oktober 2024 51
    15. oktober 2024 58
    14. oktober 2024 58
    13. oktober 2024 67
    12. oktober 2024 67
    11. oktober 2024 64
    10. oktober 2024 63
    9. oktober 2024 62
    8. oktober 2024 59
    7. oktober 2024 60