Head of Medical Writing

Head of Medical Writing (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 apply.

#J-18808-Ljbffr