Novo Nordisk
Safety Medical Writing Principal Specialist
DanmarkPosted Today
Full TimeSeniorDK
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Job Description
Global Patient Safety Søborg, Denmark Are you passionate about ensuring the safety of patients using pharmaceutical products? Do you want to have a lead role in the Safety Surveillance reporting activ
Key Highlights
- Serve as lead writer for high‑complexity aggregate safety reports, Risk Management Plans (RMPs), and responses to Health Authority questions of significant strategic importance.
- Act as a key contributor to defining the safety reporting strategy across an entire product portfolio.
- Function as a trusted advisor to cross‑functional stakeholders, influencing decisions to ensure optimal safety reporting strategies.
- Act as an informal leader, strengthening medical writing capabilities and supporting skill development across Safety Medical Writing.
- A master’s degree and/or PhD in Life Sciences (e.g., Pharmacy, Medicine, Veterinary, or Biological).
Qualifications
Required Qualifications
- A master’s degree and/or PhD in Life Sciences (e.g., Pharmacy, Medicine, Veterinary, or Biological).
- Experience within pharmacovigilance and safety medical writing, including knowledge of PSURs, DSURs, RMPs, and relevant guidelines, is preferred. We also welcome candidates with transferable experience in other regulatory-guided scientific or clinical writing.
- Demonstrated ability to translate complex safety data into concise written communication, tailored to support regulatory decision-making.
- Experience in applying AI/structured authoring or other technical solutions in medical writing is considered an advantage.
- Highly collaborative, capable of leading global and cross-functional team members.
- Excellent communication skills, both written and spoken, with fluency in English.
About the Company
Novo Nordisk
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Job Details
Employment Type
Full Time
Experience Level
Senior
Location
Danmark
Posted
Today
Country
DK