Oncology Medical Writing Director

Job Summary

Leading the strategic and operational direction of clinical and regulatory documentation for global oncology development programs, the remote Senior Director, Medical Writing will manage the planning, authoring, and delivery of key regulatory documents while overseeing a medical writing team on a contract basis.

Key responsibilities

• Lead the planning, authoring, review, and delivery of clinical and regulatory documents for oncology programs
• Develop document strategies, timelines, and resource plans across multiple projects
• Oversee the preparation of key regulatory documents, including INDs, BLAs, and Clinical Study Reports

Required qualifications

• Advanced degree (PhD, PharmD, MD, MS, or equivalent) in a life sciences discipline
• 10+ years of medical writing experience within the biotechnology or pharmaceutical industry
• 5+ years of leadership experience managing medical writing teams at a sponsor company
• Extensive oncology medical writing experience
• Experience authoring or leading at least one successful IND or BLA submission