Executive Director Medical Writing

Job Summary

Leading the PV Medical Writing function, the full-time Executive Director Medical Writing will ensure high-quality, compliant deliverables while managing and developing the medical writing team, driving quality initiatives, and providing strategic expertise to clients and stakeholders in a remote work environment.

Key responsibilities

• Lead the PV Medical Writing function to ensure timely and compliant deliverables
• Manage and develop the medical writing team, fostering performance and professional growth
• Drive quality, compliance, and continuous improvement initiatives, including oversight of SOPs and regulatory inspections

Required qualifications

• Master's degree in life sciences or healthcare; PhD preferred
• Extensive experience in pharmacovigilance and medical writing, including team leadership
• Deep knowledge of global pharmacovigilance regulations and experience with aggregate safety reports
• Proven experience with regulatory compliance and oversight, including QPPV responsibilities
• Strong business acumen with experience in proposals and client engagements