Senior Director / Executive Director Medical Writing
ERGOMEDRemotely
pharmacovigilanceregulatory complianceinspectionssopskpisauditsqppvpv medical writing
Job Description
📋 Description
- Lead the PV Medical Writing function, ensuring high-quality, compliant, and timely deliverables.
- Manage and develop the PV Medical Writing team, fostering performance, engagement, and professional
- Drive quality, compliance, inspection readiness, and continuous improvement initiatives, including
- Provide strategic PV medical writing expertise and subject matter leadership to clients, internal
- Support business development activities, including proposals, bid defenses, and client engagements.
- Oversee departmental resources, budgets, and operational performance to ensure efficient service
🎯 Requirements
- Master’s degree in life sciences or healthcare, PhD preferable
- Extensive pharmacovigilance and PV Medical Writing experience, including leadership and people
- Deep knowledge of global pharmacovigilance regulations, with expertise in authoring and reviewing
- Proven experience supporting regulatory compliance, inspections, and pharmacovigilance system
- Strong business acumen with experience supporting proposals, client engagements, and bid defense
- Excellent scientific, regulatory, and analytical capabilities, including translating complex
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