Regulatory Coordinator/Writer with Background in Analytical Chemistry

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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.


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

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