Clinical Project Manager Medical Writing

3 days ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

About the Position

We are seeking a highly skilled and experienced Regulatory Document Specialist to join our team in Clinical Reporting. As a key member of our function, you will be responsible for driving the preparation of complex clinical documents and acting as project manager.

Main Responsibilities

  • Lead tasks such as planning, development, and oversight of regulatory documents, including study protocols, informed consent forms, investigator's brochures, PIPs, clinical summaries, paediatric plans, briefing packages, and responses to health agency questions according to business needs.
  • Represent Clinical Reporting on cross-functional project teams and provide guidance on regulatory document requirements and optimal data presentation.
  • Work collaboratively with other job functions across Development (notably Biostatistics, Pharmacovigilance, Medical & Science, Regulatory Affairs, Clinical Operations) to ensure all source information and data are appropriately reported in terms of accuracy, completeness, and scientific interpretation - all in accordance with project timelines.

Qualifications

  • A Master's degree within natural sciences (M.Sc., M.Sc. Pharm., or equivalent), preferably supplemented with a PhD and ≥5 years of relevant experience as a medical writer in the pharmaceutical industry.
  • A track-record of driving your own complex tasks from start to end, navigating many different stakeholders, and being an expert in communicating scientific information.
  • The ability to improve processes and promote the sharing of better practices.
  • An expert understanding of clinical development, regulatory processes & requirements, and clinical documents.
  • Full proficiency in spoken and written English.

About Us

Clinical Reporting covers all clinical drug development projects across therapy areas. Our main focus is to use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials, and our main task is to communicate clinical data in a clear and concise manner.



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