Senior Director, Medical Writing

Job Summary

Providing strategic and operational leadership for clinical and regulatory documentation, the full-time contract Senior Director, Medical Writing will oversee document development and ensure timely delivery of high-quality regulatory documents for global oncology development programs while working remotely.

Key responsibilities

• Lead the planning, authoring, review, and delivery of clinical and regulatory documents supporting oncology development programs
• Develop document strategies, timelines, and resource plans across multiple programs
• 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
• Extensive oncology medical writing experience is required
• Experience authoring or leading at least one successful IND or BLA submission