Head, Global Labeling Innovation and Transformation
Bridgewater, New Jersey, Frankfurt am Main, Germany, São Paulo, Brazil
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Position Overview & Key responsibilities
The Head, Global Labeling Innovation & Transformation, is accountable for leading the team responsible for preparing Sanofi for Labeling of the Future in term of processes, technology, skills, and, perhaps most important, mindset.
Specific responsibilities include:
E2E Labeling Transformation
Accountable for ensuring deliverables from the various Transformation workstreams according to agreed-upon timelines
Provide monthly progress updates to the GRA Leadership Team
Initiate and lead related discussions at GRA Council meetings when decisions/endorsements are required
Promote a symbiotic way of working with the GRA Labeling Strategy and Labeling Operational Excellence groups
Define governance and identify/create continuous synergies between the 3 pillars
Align on common KPIs (e.g., those related to compliance and efficiency of process by xxx%...)
Digital Innovation Strategy
Develop and drive the strategy for implementation of Structured Content Labeling (including interface with Veeva Vault, One Translate, and other systems as applicable)
Pursue the development of Drug Label Explorer (DLE) with and its Veeva Vault interface
Innovation within GRA
Lead discussions with the GRA CMC and GRA Submissions teams on cross-fertilization between the 3 groups, harmonization of processes, and efficiency gains
Drive the discussion with GRA Regulatory Operations on processes and tools to support and accelerate innovation within GRA (e.g., Structured Content Labeling, DLE, One Translate, Veeva Vault, etc.)
Innovation beyond GRA
Lead engagement with PV on ways of working and a common transformation roadmap
Share Global Labeling’s vision with Manufacturing and Supply (M&S) and define a harmonized artwork process
Partner with M&S (project lead) and Digital to define and implement Sanofi’s enterprise-level ePI ambitions
Implement a resource model that supports Global Labeling’s innovation ambitions
Resourcing strategy (including Internal Service Hub)
At least 10 years’ experience in the biopharmaceutical industry, preferably in Regulatory Affairs with a firm understanding of end-to-end (E2E) global labeling processes
Firm understanding of the regulatory environment, drug research & development and maintenance processes and requirements
Experience in implementing process and system innovations, including digital solutions
Project leadership experience in a regulated environment
Recognized expert in leading matrixed teams
Demonstrated ability to independently lead regulatory teams and successfully implement strategies
Bachelor’s degree, preferably in the life sciences; advanced science degree preferred
People management and successful talent development track record
Strong project planning and performance tracking experience
Skills & Abilities
Working knowledge of pharmaceutical regulations and requirements
Knowledge and operational expertise of the labeling environment and regulations
Strong interpersonal skills to motivate the team and effectively liaise with internal and external partners and stakeholders
Record of successfully overseeing and implementing major process transformations, or similar global project oversight experience, including developing strong business cases for such projects
Creative and innovative thinker who envisions solutions beyond traditional approaches
Ability to effectively communicate with other functional leaders and Health Authorities
Strong organizational skills and ability to manage heavy workload under pressure
Ability to effectively work with multifunctional and multicultural teams in a matrixed organization
Ability to effectively interact, influence and negotiate with internal and external senior-level clients
Strong strategic thinker with a demonstrated ability to work transversally to achieve critical business and functional area objectives according to established deadlines
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.