Senior Director / Executive Director Medical Writing

Role Overview:

• Lead the PV Medical Writing function, ensuring high-quality, compliant, and timely deliverables.
• Manage and develop the PV Medical Writing team, fostering performance, engagement, and professional growth.
• Drive quality, compliance, inspection readiness, and continuous improvement initiatives, including oversight of SOPs, KPIs, audits, and regulatory inspections.

Key Responsibilities:

• Provide strategic PV medical writing expertise and subject matter leadership to clients, internal stakeholders, and project teams.
• Support business development activities, including proposals, bid defenses, and client engagements.
• Oversee departmental resources, budgets, and operational performance to ensure efficient service delivery.

Qualifications:

• Master’s degree in life sciences or healthcare, PhD preferable.
• Extensive pharmacovigilance and PV Medical Writing experience, including leadership and people management of high-performing teams.
• Deep knowledge of global pharmacovigilance regulations, with expertise in authoring and reviewing aggregate safety reports and PV procedures.

Additional Information:

• When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world.
• You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.