Senior Medical Writer

Category: Clinical Development

Location:Søborg, Capital Region of Denmark, DK

• Stakeholder management to drive the writing process and facilitate decision-making - you can work both independently and as part of a cross-functional team in a changing and dynamic environment with tight deadlines.

• Take charge of document preparation and coordination - the clinical documents you prepare are intended for regulatory authorities and comprise of clinical evaluation plans, clinical evaluation reports, post market clinical follow-up plans, post market clinical follow-up reports and Q&A interactions with health authorities.

• Prepare related documents such as device clinical investigation protocols, device investigator’s brochures, summary documents, and other documents relating to the interpretation and documentation of clinical data. We cover all medical device development projects within Novo Nordisk’s product portfolio.

• Act as project or product medical writer which includes support to peer medical writers, keeping an overview of incoming tasks and track of progress across deliverables to ensure that deadlines are met.

• hold a university degree within natural or clinical/medical sciences (M.Sc., M.Sc. Pharm or equivalent) and preferably a Ph.D. and/or relevant experience.

• be a clear communicator both in written and spoken English at an accomplished professional level.

• have experience with preparing clinical evaluations and trial-related documentation for medical devices, software as medical devices, drug-device combination products, or in-vitro diagnostic products.

• have some knowledge about EU-MDR requirements whereas requirements for other big markets will be regarded an asset.