Principal Specialist, Safety Medical Writing

Novo Nordisk

Safety Medical Writing Principal Specialist leading complex safety reporting activities at Novo Nordisk. Ensuring patient safety through high-quality documentation in a collaborative global environment.

Posted 7/2/2026full-timeSøborg • 🇩🇰 DenmarkLead💰 DKK 847,000 - DKK 1,245,100 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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
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
You thrive in a fast- paced, complex environment and navigate uncertainty with confidence
You are proactive, self-driven, and well organised, with strong planning and prioritisation skills
Curious and improvement-oriented, you enjoy innovating and do not shy away from challenging the status quo
You value working in a global setting and actively contribute to a team culture built on empathy, strong collaboration, having fun, and taking care of each other.

Benefits

Comp & perks

Continuous learning
Career development
Benefits tailored to your life and career stage

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Aggregate Safety ReportsPSURsDSURsRegulatory GuidelinesData Translation

Soft Skills

CollaborationProactiveOrganizational SkillsCuriosityEmpathy

Certifications

Master’s DegreePhD in Life Sciences