Senior Director / Executive Director Medical Writing
Core
Lead the Pharmacovigilance (PV) Medical Writing function, ensuring high-quality, compliant, and timely deliverables for global regulatory safety reporting.
Role type
Senior Director / Executive Director, PV Medical Writing
Builds
Regulatory safety responses, Risk Management Plans, aggregate reports, and PV procedures
Domain
Life Sciences / Pharmacovigilance / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance leadership, Global PV regulations expertise, Aggregate safety report authoring, Regulatory compliance oversight, Business development support, Budget and resource management, Scientific data translation
Preferred skills
QPPV or Deputy QPPV responsibilities, Proposal and bid defense experience, Inspection readiness, Strategic stakeholder engagement
Technologies
None stated
Responsibilities
Lead the PV Medical Writing function, Manage and develop the PV Medical Writing team, Drive quality and compliance initiatives, Provide strategic PV expertise to clients, Support business development activities, Oversee departmental resources and budgets, Review regulatory safety responses, Build and maintain client relationships, Represent the organization externally
Seniority
Senior Director, Strategic Leadership & People Management
