Join the engine of Sanofi's mission -- where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions.
The Labeling Strategist will be responsible for the labeling of a portfolio of marketed products and projects under development.
The purpose of this position is to be responsible for the preparation of corporate, US and EU labeling (prescribing information, patient information and other labeling components) for a portfolio of marketed products and projects under development, and to obtain internal company and regulatory agency approvals. Development of labeling for these products is based on study results, safety data, literature data or other information relevant to product or product class; coordination of labeling review and approval throughout the end-to-end labeling process, preparation of labeling components for submission to regulatory agencies, and participation in labeling negotiations with agencies resulting in product approvals or labeling updates.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
About You
Experience/Qualifications:
In-depth working knowledge of labeling, guidance, and agency regulatory action history is required
5 years pharmaceutical/biotechnology industry experience with a minimum of 3 years' experience in Labeling
Master's degree (Life Sciences or Health Sciences or related field preferred), OR MD, OR PharmD
Skills:
Excellent written and verbal communication skills
Negotiation skills
Demonstrated ability to solve problems and proactivity
Ability to work with multifunctional and culturally diverse teams
Organizational skills, ability to manage multiple projects at short notice.
Excellent inter-personal skills
Work with minimal oversight
Rigor, detail oriented
Fluent business English
Why Choose Us?
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
This position is for a current vacant role that we are actively hiring for.
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
#GD-SP
#LI-SP
#LI-Onsite
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Toute compensation sera determinee en fonction de l'experience demontree. Les employes peuvent etre admissibles a participer aux programmes d'avantages sociaux de l'entreprise. Des informations supplementaires sur les avantages sociaux peuvent etre trouvees ici.
Beware of fraud agents! do not pay money to get a job
MNCJobz.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.