Experienced Safety Medical Writers

Category: Clinical Development

Location:Søborg, Capital Region of Denmark, DK

• Be responsible for the preparation of complex aggregate safety reports, Risk Management Plans (RMPs), and responses to Health Authority questions
• Oversee and manage processes related to safety reporting
• Collaborate with cross-functional teams, including Clinical Development and Regulatory Affairs, to ensure high-quality scientific writing and timely reporting of safety data
• Establish close partnerships and interactions with colleagues across functions and markets, gaining extensive insights into the entire Novo Nordisk value chain
• Act as an expert for junior team members, share information, and take proactive steps to excel in your role

• A master’s degree and/or Ph D in Life Sciences (e.g., Pharmacy, Medicine, Veterinary, or Biological), combined with proven experience working within pharmacovigilance and/or medical writing
• Experience in submissions of Marketing Authorisation Applications and/or in process management
• Excellent analytical competencies and experience in working with large datasets
• Expert understanding of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) and RMPs, and the guidelines and regulations that drive their preparation
• Fluency in both written and spoken English (business language) and solid experience using MS Office