Senior Director / Executive Director Medical Writing

The Senior Director / Executive Director Medical Writing is a senior management position, member of the Senior Leadership Team; Acts as Head of PV Medical Writing Group and has primary responsibility to ensure the contracted PV activities are appropriately performed in line with company policies/procedures and in compliance with global regulations. 

Responsibilities

• 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 growth.
• Drive quality, compliance, inspection readiness, and continuous improvement initiatives, including oversight of SOPs, KPIs, audits, and regulatory inspections.
• Provide strategic PV medical writing expertise and subject matter leadership to clients, internal stakeholders, and project teams.
• Support business development activities, including proposals, bid defenses, and client engagements.
• Oversee departmental resources, budgets, and operational performance to ensure efficient service delivery.
• Review regulatory safety responses and contribute to Risk Management Plans, aggregate reports, and other key pharmacovigilance deliverables.
• Build and maintain strong client relationships, ensuring exceptional service and trusted partnerships.
• Represent the organization externally through industry engagement, publications, presentations, and professional development activities.