Senior Director – Medical Writing

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

📋 Description

• Oversee the PV Medical Writing function, guaranteeing timely, compliant, and high-quality deliverables.

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

• Lead initiatives for quality, compliance, inspection readiness, and continuous enhancement, including the supervision of SOPs, KPIs, audits, and regulatory inspections.

• Offer strategic expertise in PV medical writing and serve 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, budgets, and operational efficiency to guarantee effective service delivery.

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

• Establish and maintain robust client relationships, ensuring outstanding service and reliable partnerships.

• Represent the organization externally through industry involvement, publications, presentations, and professional development activities.

⛳️ Requirements

• Master’s degree in life sciences or healthcare.

• PhD is preferable.

• Extensive experience in pharmacovigilance and PV Medical Writing, including leadership and management of high-performing teams.

• In-depth understanding of global pharmacovigilance regulations.

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

• Proven track record in supporting regulatory compliance, inspections, and oversight of pharmacovigilance systems.

• Experience with QPPV or Deputy QPPV responsibilities.

• Strong business acumen with a background in supporting proposals, client engagements, and bid defense initiatives.

• 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 options available.

• Flexible work environment.

• Opportunities for professional growth and development.

• A collaborative and supportive team culture.

• An inclusive and belonging workplace.

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