Senior Director – Medical Writing

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Lead the pharmacovigilance (PV) Medical Writing function to ensure the delivery of high-quality, compliant, and timely outputs.

• Manage and nurture the PV Medical Writing team, promoting performance, engagement, and professional advancement.

• Initiate and drive quality, compliance, inspection readiness, and continuous improvement initiatives.

• Supervise standard operating procedures (SOPs), key performance indicators (KPIs), audits, and regulatory inspections.

• Offer strategic expertise in PV medical writing and serve as a subject matter leader for clients, internal stakeholders, and project teams.

• Assist in business development efforts, including proposals, bid defenses, and client interactions.

• Manage departmental resources, budgets, and evaluate operational performance.

• Review regulatory safety responses and contribute to Risk Management Plans, aggregate reports, and other pharmacovigilance deliverables.

• Establish and maintain robust client relationships.

• Represent the organization externally through industry engagement, publications, presentations, and professional development activities.

⛳️ Requirements

• A Master’s degree in life sciences or healthcare is preferred; a PhD is highly desirable.

• Substantial experience in pharmacovigilance and PV Medical Writing.

• Proven leadership and people management experience with high-performing teams.

• Comprehensive understanding of global pharmacovigilance regulations.

• Expertise in authoring and reviewing aggregate safety reports and PV procedures.

• Experience in supporting regulatory compliance, inspections, and oversight of pharmacovigilance systems.

• Familiarity with QPPV or Deputy QPPV responsibilities.

• Strong business acumen and experience in supporting proposals, client engagements, and bid defense activities.

• Excellent scientific, regulatory, and analytical skills.

• Capability to convert complex clinical and safety data into clear, high-quality regulatory and scientific documents.

🏝️ Benefits

• Option for remote work.

• A flexible work culture.

• Opportunities for growth and professional development.

• A collaborative and supportive team environment.

• A workplace culture that promotes belonging and inclusivity.

• Opportunities for industry engagement, publications, presentations, and professional development activities.