Executive Director of Medical Writing

Job Summary

Leading the Medical Writing function, the full-time Executive Director of Medical Writing will provide strategic and operational leadership to ensure the delivery of high-quality regulatory documentation while collaborating with cross-functional teams in a remote setting.

Key responsibilities

• Lead the strategic direction and operational capabilities of the Medical Writing function to support the development portfolio
• Oversee the planning, development, and delivery of complex regulatory and scientific documents throughout the product lifecycle
• Build and mentor a high-performing Medical Writing organization while fostering a culture of scientific excellence and continuous improvement

Required qualifications

• Advanced degree in life sciences, pharmacy, medicine, or related discipline (PhD, PharmD, MD, or equivalent preferred)
• 12+ years of progressive medical writing experience within the biotechnology or pharmaceutical industry, including significant leadership experience
• Demonstrated success in leading Medical Writing organizations supporting global clinical development and regulatory submissions
• Deep understanding of global regulatory requirements and guidance (FDA, EMA, ICH) across the product lifecycle
• Proven ability to influence cross-functional decision-making and build collaborative relationships across senior leadership teams