Senior Medical Writer & Regulatory Project Lead

Cari; Søborg; Remoto; DKK 651.000 - 957.000; Tempo pieno

Descrizione del lavoro

Novo Nordisk in Søborg, Denmark, offers a permanent Medical Writing role focused on driving complex clinical documents and serving as a project manager. You will lead regulatory and clinical document planning, preparing protocols, consent forms, brochures, and summaries, while guiding cross-functional teams to ensure scientifically sound reporting.

You will collaborate with regulatory, clinical operations, biostatistics, and pharmacovigilance colleagues, applying your MSD to ensure timely,

Competenze

• Master’s degree within natural sciences (MSc., MSc. Pharm. or equivalent), preferably with a PhD and/or relevant industry experience.
• Track record of driving complex tasks from start to end with multidisciplinary stakeholders.
• High level of expertise in communicating scientific information tailored to diverse objectives.
• Ability to improve processes and promote sharing of best practices.
• Good understanding of clinical development, regulatory processes and clinical documents.
• Full proficiency in spoken and written English.

Mansioni

• Plan, develop, and oversee high-quality regulatory and clinical documents aligned 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, guiding document planning and data presentation.
• Collaborate with Medical & Science, Regulatory Affairs, Clinical Operations, Biostatistics, and Pharmacovigilance to ensure accurate reporting.

Conoscenze

Scientific communication

Project management

Stakeholder management

Process improvement

Clinical development knowledge

English proficiency

Formazione

Master’s degree in natural sciences

PhD (beneficial)

Descrizione del lavoro

Novo Nordisk in Søborg, Denmark, offers a permanent Medical Writing role focused on driving complex clinical documents and serving as a project manager. You will lead regulatory and clinical document planning, preparing protocols, consent forms, brochures, and summaries, while guiding cross-functional teams to ensure scientifically sound reporting.

You will collaborate with regulatory, clinical operations, biostatistics, and pharmacovigilance colleagues, applying your MSD to ensure timely,