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

Virtual Vocations Inc is hiring: Senior Director Medical Writing in None
Virtual Vocations Inc · None, US, USA · Remote ·
- Job type:
- Full Time