Global Medical Writing Franchise Head - Vaccines

Role Summary

The Global Medical Writing Franchise Head - Vaccines leads a global team of Medical Writers within the Vaccine Clinical Documentation group, ensuring timely delivery of high-quality clinical content and documentation. The role supports clinical development, regulatory submissions, marketing applications, and lifecycle management of the Vaccine portfolio, prepared in accordance with regulatory specifications and strategic messaging.

Responsibilities

• Lead, manage, advise, mentor and evaluate an international team of Medical Writers across regional sites to align objectives with departmental mission and evolving needs.
• Represent Medical Writing in strategic meetings and with external partners; ensure support to produce clinical and submission documents that meet Health Authority requirements and internal standards.
• Participate in the review of strategic clinical documents (e.g., protocol ID card, Common Technical Document) for quality and scientific content.
• Develop an outsourcing strategy for document production to enable cost-effective, timely delivery of quality documents.
• Manage and allocate human and financial resources for medical writing activities to achieve VCD goals.
• Support changes, training, development, and evaluation of Medical Writers.
• Contribute to process improvement and adoption of innovative technologies to increase efficiencies and reduce costs.

Qualifications

• Master's degree is the minimum education requirement; advanced degree in a scientific field is preferred.
• 7+ years of experience in the pharmaceutical industry with some team management experience.
• Experience preparing regulated documentation for health agencies in support of drug development, or equivalent experience in Regulatory Affairs or Medical Affairs; knowledge of Vaccine Clinical Development is an asset.

Skills

• Knowledge of regulatory guidelines and submission standards.
• Understanding of how other functions (biostatistics, pharmacovigilance, clinical development, regulatory) contribute to clinical documents.
• Experience collaborating with external partners (CROs, KOLs, vendors).
• Strong leadership, strategic thinking, and innovation ability; stakeholder negotiation and conflict resolution.
• Experience managing people, budgets, and change; basic finance and HR understanding.
• Global project/clinical experience with the ability to lead teams across time zones.
• Awareness of electronic document management, content reuse, and submission tools and technologies.
• Ability to collaborate across cultures and adapt to a changing business environment.
• Willingness to engage in dialogue with management, customers, and colleagues to give and receive feedback; diplomacy and networking skills.

Education

• Master's degree required; advanced degree preferred.