Director of Medical Writing (Pharmaceutical, Hellerup)

Job summary

This role involves overseeing the preparation of clinical regulatory documents and collaborating with cross-functional teams to ensure effective communication of clinical data in a regulatory context.

Qualifications

• Relevant academic degree (preferably Master’s or higher).
• 10+ years of experience in Medical Writing within the pharmaceutical industry.
• Proven experience in leading submission preparation (NDA/BLA/MAA).
• Strong verbal and written communication skills in English.

Responsibilities

• Plan, develop, and oversee diverse clinical regulatory documents such as CSRs, Investigator Brochures, and briefing packages.
• Represent Medical Writing on cross-functional project teams, providing guidance on regulatory document requirements.
• Lead or contribute to the optimization of processes, systems, and standards related to medical writing.
• Prepare or review documents for public release, including lay language summaries.

Skills

• Ability to work with and lead global teams.
• Strong understanding of clinical trial data interpretation and communication.
• Interest in improving medical writing processes, including digital/AI solutions.

Education

• Master’s degree or higher in a relevant field.

Tools

• Familiarity with regulatory document standards and submission processes.