Head of Medical Writing

📋 Description

• Define and own Medical Writing strategy aligned with pipeline and regulatory milestones.
• Establish standards, processes, and governance for quality and inspection readiness.
• Partner with Regulatory Affairs to integrate Medical Writing into regulatory strategy and submissions.
• Drive platform-based document development and content reuse across programs.
• Lead internal Medical Writing team; manage vendors and cross-functional partners.
• Shape future capabilities including AI-enabled writing and Bayer collaboration.

🎯 Requirements

• PhD/PharmD/MD or advanced degree; Bachelor’s required.
• 10+ years medical writing in biopharma; cell/gene therapy preferred.
• Global regulatory writing leadership (INDs/CTAs; BLAs/MAAs).
• Deep knowledge of drug/biologics development, CTD, ICH, GxP.
• Strong leadership and cross-functional collaboration.
• Travel up to 20% (US/Canada; limited EU).