Senior Director Medical Writing

Job Summary

Leading the PV Medical Writing function, the full-time Senior Director Medical Writing will ensure high-quality, compliant deliverables while managing and developing the 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, ensuring timely and compliant deliverables
• Manage and develop the PV Medical Writing team to foster performance and engagement
• 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 PV Medical Writing, including leadership of high-performing teams
• Deep knowledge of global pharmacovigilance regulations and expertise in safety report authoring
• Proven experience with regulatory compliance and pharmacovigilance system oversight
• Strong business acumen with experience in proposals and client engagements