Senior Director – Medical Writing

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Logo of ERGOMED

ERGOMED

1001 - 5000 employees

Founded 1997

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Lead the PV Medical Writing function • Manage and develop the PV Medical Writing team • Drive quality, compliance, inspection readiness, and continuous improvement initiatives • Provide strategic PV medical writing expertise • Support business development activities • Oversee departmental resources, budgets, and operational performance • Review regulatory safety responses

🎯 Requirements

• Extensive pharmacovigilance and PV Medical Writing experience • Deep knowledge of global pharmacovigilance regulations • Proven experience supporting regulatory compliance • Strong business acumen with experience supporting proposals • Excellent scientific, regulatory, and analytical capabilities

🏖️ Benefits

• Collaborative team environment • Professional development opportunities • Global reach and opportunity to make a difference

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