Senior Director – Medical Writing

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

📋 Description

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

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

• Champion quality, compliance, readiness for inspections, 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 serve as a subject matter expert to clients, internal stakeholders, and project teams.

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

• Oversee departmental resources, budget management, 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

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

• Significant experience in pharmacovigilance and PV Medical Writing.

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

• In-depth understanding of global pharmacovigilance regulations.

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

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

• Experience with QPPV or Deputy QPPV responsibilities.

• Strong business acumen and experience in supporting proposals, client interactions, and bid defense efforts.

• Excellent scientific, regulatory, and analytical skills.

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

🏝️ Benefits

• Option for remote work.

• Opportunities for professional growth.

• Flexible work culture.

• Collaborative and supportive team environment.

• Professional development activities.

• Exposure to a global team and international experiences.