Senior Director – Medical Writing

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

📋 Description

• Oversee the PV Medical Writing function, ensuring deliverables are of high quality, compliant, and produced in a timely manner.

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

• Lead initiatives focused on quality, compliance, inspection readiness, and continuous improvement.

• Supervise SOPs, KPIs, audits, and regulatory inspections.

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

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

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

• 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 preferable.

• Extensive experience in pharmacovigilance and PV Medical Writing.

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

• In-depth understanding of global pharmacovigilance regulations.

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

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

• Experience with QPPV or Deputy QPPV responsibilities.

• Strong business acumen.

• Experience in supporting proposals, client engagements, and bid defense activities.

• Excellent scientific, regulatory, and analytical skills.

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

🏝️ Benefits

• Remote work options available.

• Flexible working environment.

• Opportunities for growth and professional development.

• A collaborative and supportive team culture.

• Engaging professional development activities.

• Chance to work on projects that have a global impact and meaningful purpose.