Senior Director – Medical Writing

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

📋 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 development.

• Propel quality, compliance, inspection readiness, and initiatives for continuous improvement.

• Supervise Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), audits, and regulatory inspections.

• Offer strategic expertise in PV medical writing and subject matter leadership to clients, internal stakeholders, and project teams.

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

• Manage 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 involvement, publications, presentations, and professional development activities.

⛳️ Requirements

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

• Significant experience in pharmacovigilance and PV Medical Writing.

• Experience in leadership and people management with high-performing teams.

• Extensive understanding of global pharmacovigilance regulations.

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

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

• Familiarity with QPPV or Deputy QPPV responsibilities.

• Strong business acumen along with experience in supporting proposals, client interactions, and bid defense activities.

• Exceptional scientific, regulatory, and analytical skills.

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

🏝️ Benefits

• Remote work opportunities.

• Flexible working environment.

• Opportunities for growth and professional development.

• A collaborative and supportive culture.

• Chance to work with global teams.

• Engagement in industry activities, publications, presentations, and professional development initiatives.