Senior Director / Executive Director Medical Writing

Ergomed; Madrid; Presencial; EUR 180.000 - 240.000; Jornada completa

Descripción de la vacante

Ergomed is seeking a Senior Director / Executive Director Medical Writing to lead the PV Medical Writing function and align contracted activities with global regulations. The role sits on the Senior Leadership Team, driving quality, compliance, and strategic leadership across projects and clients.

We value experts who can mentor teams, oversee regulatory submissions, and build strong client relationships while advancing pharmacovigilance excellence on a global scale.

Formación

• Extensive pharmacovigilance and PV Medical Writing experience, including leadership and people management.
• Deep knowledge of global pharmacovigilance regulations, with expertise in authoring/ reviewing aggregate safety reports.
• Proven experience supporting regulatory compliance, inspections, and PV system oversight.
• Strong ability to translate complex clinical and safety data into regulatory and scientific documents.
• Experience supporting proposals, client engagements, and bid defenses.
• Excellent scientific, regulatory and analytical capabilities.

Responsabilidades

• 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 SOPs, KPIs, audits, and regulatory inspections.
• Provide strategic PV medical writing 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.
• Review regulatory safety responses and contribute to Risk Management Plans, aggregate reports, and other PV deliverables.
• Build and maintain strong client relationships, ensuring exceptional service and trusted partnerships.
• Represent the organization externally through industry engagement, publications, presentations, and professional development activities.

Conocimientos

PV leadership

Regulatory knowledge

Stakeholder management

Strategic thinking

Descripción del empleo

Medicine moves forward here. So will you.

At PrimeVigilance, patient safety is not one part of the job. It is why we exist.

We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post‑marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.

That work takes curious minds, problem‑solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.

If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.

The Senior Director / Executive Director Medical Writing is a senior management position, member of the Senior Leadership Team; Acts as Head of PV Medical Writing Group and has primary responsibility to ensure the contracted PV activities are appropriately performed in line with company policies/procedures and in compliance with global regulations.

Responsibilities

• 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.
• 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.
• Review regulatory safety responses and contribute to Risk Management Plans, aggregate reports, and other key pharmacovigilance deliverables.
• Build and maintain strong client relationships, ensuring exceptional service and trusted partnerships.
• Represent the organization externally through industry engagement, publications, presentations, and professional development activities.

Preferred candidate will have

• 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.
• Proven experience supporting regulatory compliance, inspections, and pharmacovigilance system oversight, including QPPV or Deputy QPPV responsibilities.
• Strong business acumen with experience supporting proposals, client engagements, and bid defense activities.
• Excellent scientific, regulatory, and analytical capabilities, including translating complex clinical and safety data into clear, high‑quality regulatory and scientific documents.

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.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality: we hold ourselves to the standard patients deserve.
• Integrity and trust: we do the right thing, especially when it is hard.
• Drive and passion: we care about the outcome, because someone is waiting on it.
• Agility and responsiveness: we move quickly, because patients cannot wait.
• Belonging: everyone is welcome, and every voice counts.
• Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.