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 in a remote work environment.

Key responsibilities

• Lead the PV Medical Writing function to deliver compliant and timely outputs
• Manage and develop the writing team, promoting performance and professional growth
• Oversee quality, compliance, and continuous improvement initiatives, including audits and regulatory inspections

Required qualifications

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