Global Medical Writing Franchise Head - Vaccines

Sanofi • Pocono Township, PA

49d • Remote

About The Position

The Global Medical Writing Franchise Head is part of the Vaccine Clinical Documentation group and will manage a global group of Medical Writers who are assigned to the different projects/clinical trials part of the Franchise. In this role, you will be accountable for the timely delivery of high-quality clinical content and documentation, within the scope of the assigned franchise, prepared in accordance with regulatory specifications and strategic messaging to support the clinical development, marketing applications and lifecycle management of the Vaccine portfolio. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Requirements

• Master's degree is the minimum education requirement. Advanced degree in a scientific related field is preferred.
• 7+ years of experience in the pharmaceutical industry with some team management experience.
• Candidate should have experience preparing regulated documentation for health agencies in support of drug development, or equivalent experience in Regulatory Affairs or Medical Affairs.
• Knowledge of regulatory or other guidelines pertaining to document standards and submission requirements.
• Understanding of the functioning and constraints of other functions providing input to clinical documents (biostatistics, pharmacovigilance, clinical development, regulatory, etc.)
• Collaborative experience with external partners providing resources or expertise with contract research organizations (CROs), key opinion leaders (KOLs), vendors, etc.
• Strong leadership ability, coupled with strategic and innovative thinking.
• Proven ability to manage people, budgets and change; negotiate and influence others, and resolve conflict.
• Understanding of business considerations (basic finance, human resources).
• Extensive project and/or clinical experience in a global environment and the ability to lead others to complete projects.
• Awareness of electronic document management, content re-use and submission tools, trends and technologies.
• Capable of working collaboratively across different cultures and time zones.
• Ability to adapt to needs of a changing business environment (e.g., regulatory requirements, corporate structure and processes, customer focus, technological advances).
• Willingness to engage in dialogue with management, customers, and colleagues to give and receive feedback.
• Diplomacy, negotiation skills, and ability to network.

Nice To Haves

• Knowledge of Vaccine Clinical Development is an asset.

Responsibilities

• Lead, manage, advise, mentor and evaluate a culturally diverse, international team of Medical Writers located at different regional sites, ensuring alignment of objectives, goals, and understanding with the mission of the department and current needs of the changing environment, internal and external.
• Represent the Medical Writing function in different strategic meetings (e.g. Clinical and Regulatory Strategic forum (CRSF), CTD advisory board) and with external partners; ensure medical writing support to produce clinical and submission documents that meet the requirements of Health Authorities, as well as internal standards.
• Participate in the review of strategic clinical documents (e.g. protocol ID card, Common Technical Document) prepared by the team to ensure appropriate quality and scientific content.
• With the support of the Global Head of Vaccines clinical documentation, develop an outsourcing strategy for document production, focused on cost-effective delivery of timely documents of appropriate quality.
• Manage and allocate human and financial resources related to medical writing activities for the effective realization of the goals of VCD.
• Support changes, training & development, and evaluation of Medical Writers.
• Contribute to the development and implementation of process improvement and innovative technologies to bring efficiencies and cost savings.

Benefits

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees