Senior Medical Writer & Regulatory Project Lead

Novo Nordisk; Denmark; On-site; DKK 651,000 - 957,000; Full time

Benefits offered by this job

Incentives

Career development

Salary information

Job summary

Novo Nordisk in Søborg, Denmark, is offering a permanent Medical Writing position to drive the preparation of complex regulatory documents and to act as a project manager within cross-functional teams.

You will plan and oversee high-quality documents such as study protocols, informed consent forms, investigator's brochures, clinical summaries and pediatric plans, while coordinating with Medical & Science, Regulatory Affairs, Clinical Operations, Biostatistics, and Pharmacovigilance.

Qualifications

• Master's degree in natural sciences or equivalent; PhD advantageous.
• Experience driving complex tasks with multidisciplinary stakeholders.
• Proven ability to tailor scientific information for diverse audiences.
• Strong planning, coordination, and process-improvement mindset.

Responsibilities

• Drive preparation of complex regulatory and clinical documents aligned with timelines.
• Lead tasks: study protocols, informed consent forms, investigator's brochures, clinical summaries, pediatric plans.
• Develop briefing packages and responses to health authority questions.
• Represent Clinical Reporting in cross-functional project teams with guidance on planning and data presentation.
• Collaborate with Medical & Science, Regulatory Affairs, Clinical Operations, Biostatistics and Pharmacovigilance to ensure rigorous reporting.

Skills

Project management

Scientific communication

Stakeholder management

English proficiency

Education

Master's degree in natural sciences

PhD (preferred)

Job description

Novo Nordisk in Søborg, Denmark, is offering a permanent Medical Writing position to drive the preparation of complex regulatory documents and to act as a project manager within cross-functional teams.

You will plan and oversee high-quality documents such as study protocols, informed consent forms, investigator's brochures, clinical summaries and pediatric plans, while coordinating with Medical & Science, Regulatory Affairs, Clinical Operations, Biostatistics, and Pharmacovigilance.