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.
Senior Director – Medical Writing
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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, 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.
🎯 Requirements
• 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 defense activities. • Excellent scientific, regulatory, and analytical capabilities, including translating complex clinical and safety data into clear, high-quality regulatory and scientific documents.
🏖️ Benefits
• Flexible working hours • Professional development opportunities
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