Senior Director, Medical Writing

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