Senior Director – Medical Writing

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

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 and ensure high-quality, compliant, 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 • Oversee 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, proposals, bid defenses, and client engagements • Oversee departmental resources, budgets, and operational performance • Review regulatory safety responses and contribute to Risk Management Plans, aggregate reports, and other pharmacovigilance deliverables • Build and maintain strong client relationships • Represent the organization externally through industry engagement, publications, presentations, and professional development activities

🎯 Requirements

• Master’s degree in life sciences or healthcare preferred; PhD preferable • Extensive pharmacovigilance and PV Medical Writing experience • Leadership and people management experience with high-performing teams • Deep knowledge of global pharmacovigilance regulations • Expertise authoring and reviewing aggregate safety reports and PV procedures • Experience supporting regulatory compliance, inspections, and pharmacovigilance system oversight • Experience with QPPV or Deputy QPPV responsibilities • Business acumen and experience supporting proposals, client engagements, and bid defense activities • Strong scientific, regulatory, and analytical capabilities • Ability to translate complex clinical and safety data into clear, high-quality regulatory and scientific documents

🏖️ Benefits

• Remote work option • Flexible work culture • Growth and professional development opportunities • Collaborative and supportive team environment • Belonging and inclusive workplace culture • Industry engagement, publications, presentations, and professional development activities