Senior Director / Executive Director Medical Writing

📋 Description

• Lead the PV Medical Writing function with focus on high-quality, compliant, timely deliverables.
• Manage and develop the PV Medical Writing team for performance and growth.
• Drive quality, compliance, inspection readiness, SOPs, KPIs, audits and regulatory inspections.
• Provide strategic PV medical writing expertise 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 for efficient service delivery.

🎯 Requirements

• Extensive pharmacovigilance and PV Medical Writing experience with leadership of high-performing
• Deep knowledge of global pharmacovigilance regulations and expertise in aggregate safety reports
• Experience supporting regulatory compliance, inspections, and PV system oversight (QPPV or Deputy
• Strong business acumen with experience in proposals, client engagements, and bid defense activities.
• Excellent scientific, regulatory, and analytical capabilities; ability to translate complex data

🎁 Benefits

• Global pharmacovigilance environment with opportunities for growth and international collaboration.
• Culture focused on quality, integrity, drive, agility, and belonging.