Senior Director / Executive Director Medical Writing

Lead the PV Medical Writing function, ensuring high-quality, compliant, and timely deliverables while managing and developing the team for performance and 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.