Senior Director of Medical Writing

Job Summary

To support a growing biopharmaceutical company, the full-time Senior Director of Medical Writing will lead the development of clinical and regulatory documents, manage timelines and vendor relationships, and ensure compliance with health authority guidelines in a fully remote setting.

Key Responsibilities

• Author and oversee the development of clinical study protocols, reports, and related documents from concept to submission-ready status
• Lead medical writing for regulatory submissions, including IND applications and briefing documents, ensuring adherence to regulatory standards
• Manage document review processes and collaborate with cross-functional teams to resolve conflicting comments and ensure clarity in all communications

Required Qualifications

• Bachelor's degree in a life science; advanced scientific or medical degree preferred
• 10+ years of regulatory medical writing experience in the biotechnology or pharmaceutical industry
• Proven lead-author experience on clinical documents such as protocols and study reports
• Strong understanding of health authority regulations, ICH guidelines, and medical writing standards
• Experience managing document timelines and collaborating with cross-functional teams