Head of Medical Writing

🔭 Head of Medical Writing I Remote, Europe

💥 Role Summary
Responsible for leading the strategic direction, operational excellence, and growth of a global medical writing function supporting regulatory, clinical, and scientific communications activities across Europe and North America.

💢 Key Responsibilities
- Lead and mentor a team of 5 medical writers across regulatory and medical communications disciplines.
- Develop and implement medical writing strategies aligned with clinical development and business objectives.
- Oversee the delivery of regulatory documents including CSRs, protocols, investigator brochures, CTD modules, and submission dossiers.
- Partner with Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Medical Affairs leadership.
- Drive process improvements and adoption of AI-enabled writing technologies.
• Support business development activities, client presentations, and proposal development.

🧪 Key Achievements
• Built and scaled a medical writing department from 8 to 25 writers across Europe.
• Reduced document delivery timelines by 30% through process optimisation.
• Supported multiple successful EMA and FDA submissions.

Required Expertise
• Regulatory Writing
• Clinical Development
• Medical Communications
• Publication Planning
• Team Leadership
• EMA & FDA Submissions
• Vendor Management

If this sounds like you or someone you know feel free to drop me a message or an email to [click apply]