Senior Director – Medical Writing

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

📋 Description

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

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

• Champion initiatives related to quality, compliance, inspection readiness, and ongoing improvements.

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

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

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

• Oversee departmental resources, budgeting, and operational efficacy.

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

• Establish and sustain strong client relationships.

• Represent the organization in external settings through industry involvement, publications, presentations, and professional development initiatives.

⛳️ Requirements

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

• Significant experience in pharmacovigilance and PV Medical Writing.

• Proven leadership and people management skills within high-performing teams.

• Comprehensive understanding of global pharmacovigilance regulations.

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

• Experience in ensuring 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 efforts.

• Exceptional scientific, regulatory, and analytical skills.

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

🏝️ Benefits

• Remote work opportunities.

• Flexible work environment.

• Opportunities for growth and professional development.

• A collaborative and supportive culture.

• A workplace that fosters belonging and inclusivity.

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