Global Medical Writing Franchise Head - Vaccines

Role Summary

Global Medical Writing Franchise Head - Vaccines oversees a global team of Medical Writers across multiple projects/clinical trials within the Vaccine Clinical Documentation group, ensuring timely delivery of high-quality clinical content and documentation aligned with regulatory specifications and strategic messaging to support development, submissions, and lifecycle management of the Vaccine portfolio.

Responsibilities

• Lead, manage, advise, mentor and evaluate a culturally diverse, international team of Medical Writers at different regional sites, aligning objectives with department mission and changing needs.
• Represent the Medical Writing function 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 review of strategic clinical documents (e.g., protocol ID cards, Common Technical Document) for quality and scientific content.
• With the Global Head of Vaccines clinical documentation, develop an outsourcing strategy for document production focused on 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 innovative technologies to drive efficiencies and cost savings.

Qualifications

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

Skills

• Knowledge of regulatory guidelines and submission requirements.
• Understanding of collaboration with biostatistics, pharmacovigilance, clinical development, regulatory, and other input functions.
• Experience working with CROs, KOLs, vendors, and external partners.
• Strong leadership, strategic and innovative thinking; ability to manage people, budgets, and change; negotiation and conflict resolution skills; basic business understanding.
• Extensive global project experience and ability to lead teams across time zones.
• Familiarity with electronic document management, content re-use, and submission tools.
• Ability to adapt to changing regulatory, corporate, and technological environments; strong communication and feedback skills.

Education

• Master's degree required; advanced degree in a scientific field preferred.

Additional Requirements

• Ability to collaborate across cultures and time zones; willingness to engage with management and stakeholders to give and receive feedback.