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 the PV Medical Writing Group and has primary responsibility for ensuring that contracted PV activities are performed in line with company policies, procedures and 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.
Qualifications

Extensive pharmacovigilance and PV Medical Writing experience, including leadership and people‑management of high‑performing teams.
Deep knowledge of global pharmacovigilance regulations with expertise in authoring and reviewing aggregate safety reports and PV procedures.
Proven experience supporting regulatory compliance, inspections and pharmacovigilance system oversight, including QPPV or Deputy QPPV responsibilities.
Strong business acumen with experience supporting proposals, client engagements and bid defence activities.
Excellent scientific, regulatory and analytical capabilities, including translating complex clinical and safety data into clear, high‑quality regulatory and scientific documents.

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