Senior Director / Executive Director Medical Writing
HybridSarajevo, Federation of B&H, Bosnia and Herzegovina
Job Summary
Lead the PV Medical Writing function, ensuring high-quality, compliant, and timely deliverables while managing and developing the team to foster performance and professional growth. Drive quality, compliance, and inspection readiness through oversight of SOPs, KPIs, audits, and regulatory inspections. Provide strategic PV medical writing expertise to clients and stakeholders, supporting business development activities including proposals and bid defenses. Oversee departmental resources, budgets, and operational performance to ensure efficient service delivery. Review regulatory safety responses, contribute to Risk Management Plans, and build strong client relationships. Represent the organization externally through industry engagement and publications.
Required Qualifications
- Extensive pharmacovigilance and PV Medical Writing experience
- Leadership and people management of high-performing teams
- Deep knowledge of global pharmacovigilance regulations
- Expertise in authoring and reviewing aggregate safety reports and PV procedures
- Proven experience supporting regulatory compliance, inspections, and pharmacovigilance system oversight
- QPPV or Deputy QPPV responsibilities
- Strong business acumen
- Experience supporting proposals, client engagements, and bid defense activities
- Excellent scientific, regulatory, and analytical capabilities
- Translating complex clinical and safety data into clear, high-quality regulatory and scientific documents
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