Director of Medical Writing

Job Summary

Providing strategic and operational leadership, the full-time Director of Medical Writing will manage the planning, development, and delivery of high-quality clinical and regulatory documents in a fully remote environment.

Key responsibilities

• Direct and author complex regulatory document preparation, including INDs, NDAs, and clinical protocols
• Develop and execute the Medical Writing functional strategy aligned with corporate objectives and maintain high-quality document delivery standards
• Lead strategic planning for medical writing deliverables across development programs and ensure compliance with global regulatory requirements

Required qualifications

• Bachelor's degree in Life Sciences or related discipline; advanced degree (PhD, PharmD, MD, or Master's) preferred
• Minimum of 12 years of experience in the biopharmaceutical industry, with at least 10 years in medical writing
• At least 3 years of people leadership or functional management experience
• Demonstrated success with complex global regulatory submissions, including INDs, NDAs, and BLAs
• Extensive knowledge of global regulatory requirements and guidelines, including FDA, EMA, ICH, and GCP