Senior Director – Executive Director, Medical Writing

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

📋 Description

• Lead the pharmacovigilance (PV) Medical Writing function, ensuring 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 PV medical writing expertise and subject matter leadership to clients, internal stakeholders, and project teams.

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

• Oversee departmental resources, budgets, and operational performance.

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

• Establish and maintain robust client relationships.

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

⛳️ Requirements

• Master’s degree in life sciences or healthcare.

• Extensive experience in pharmacovigilance and PV Medical Writing.

• Leadership and people management experience with high-achieving teams.

• In-depth knowledge 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.

• Business acumen and experience in supporting proposals, client interactions, and bid defense initiatives.

• Exceptional scientific, regulatory, and analytical skills.

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

• PhD is preferable.

🏝️ Benefits

• Option for remote work.

• Opportunities for professional growth and development.

• Collaborative and supportive workplace environment.

• Flexible work culture.

• Exposure to a global team and international experiences.

• Opportunities for professional development activities.

• Opportunities for industry engagement, publications, and presentations.