Senior Director Medical Writing

Posted yesterday

virtual vocationsDenver (CO)

Regulatory Affairs ManagersResearch and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Manager

About the role

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

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