Regulatory Affairs
Experienced Medical Writer, Regulatory, Quality & Clinical Reporting, Søborg, Denmark
Opportunity summary
Pay: 651,000–956,900 DKK per year. Country: Denmark. This role is an exciting opportunity to blend scientific expertise with impactful communication, helping shape innovative healthcare solutions at a globally leading company like Novo Nordisk! Your new the role This is a permanent position in Medical Writing.
In this role, your main responsibility will be to drive the preparation of complex clinical documents and act as a project manager. More specifically, you are expected to lead tasks such as:
- - Plan, develop, and oversee high-quality regulatory and clinical documents in line with business needs and timelines.
- - Prepare key documents such as study protocols, informed consent forms, investigator’s brochures, clinical summaries, and paediatric plans.
- - Develop briefing packages and responses to health authority questions.
- - Represent Clinical Reporting in cross-functional project teams, providing guidance on document planning, requirements, and optimal data presentation.
- - Collaborate across Medical & Science, Regulatory Affairs, Clinical Operations, Biostatistics, and Pharmacovigilance to ensure accurate, complete, and scientifically sound reporting.
- We are globally oriented and you will work in close collaboration with colleagues in cross-functional teams in both Denmark and abroad.
- The position is office-based in Søborg, Denmark1 …
This is a shortened extract from the public vacancy. Follow the original posting for the complete and authoritative description.