Executive Director of Medical Writing

Job Summary

Providing strategic leadership for the medical writing function, the full-time Executive Director of Medical Writing will manage the planning, development, and delivery of clinical and regulatory documents while collaborating with various departments to ensure compliance and operational excellence in a remote setting.

Key responsibilities:

• Lead the medical writing team to establish departmental goals and oversee the development of clinical and regulatory documents
• Direct cross-functional collaboration to ensure consistency in scientific messaging and alignment on document strategy
• Implement standards and processes to enhance document quality, efficiency, and compliance with regulatory requirements

Required qualifications:

• Advanced scientific degree (PhD, PharmD, MD, or equivalent)
• 15+ years of experience in medical writing within the pharmaceutical or biotechnology industry, including leadership experience
• Demonstrated success in preparing major regulatory submissions (INDs, NDAs, MAAs)
• Strong knowledge of drug development processes, with a preference for oncology experience
• Proven ability to lead cross-functional teams and manage competing priorities effectively