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Regulatory Data, Digital and AI Business Head_ All Genders

Bridgewater, New Jersey
Paris, France
Cambridge, Massachusetts
Permanent Date posted 09/07/2024
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  • Location: North America (Cambridge, Bridgewater), Paris, France

  • Job type: Permanent

  • 30% overall business travel.

About the job :

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

MAIN GOALS:

  • Get a set of digital, data and AI products or features delivered that will increase the impact of regulatory associates, support the regulatory strategy, and accelerate submission and approvals,

  • Increase access to Regulatory data broadly to GRA and Sanofi, allowing better decisions, higher system interoperability and AI at scale,

  • Increase the quality of the Regulatory data (completeness, timeliness, consistency) to ensure compliance, enable system integration and enable AI at scale,

  • Drive alignment on data standards (MDM) with other functions at Sanofi, with peers and Health Authorities (IDMP, …) to enable data in the cloud and transition from document to data submissions,

  • Enable Regulatory process and system integration at GRA and with other Sanofi functions,

  • Strengthen the dialog with the business and the end users, to better align Regulatory Data, Digital & AI strategy with the business needs as well as user feedbacks and experience,

  • Increase the user satisfaction and the quality of the user experience within and across all Regulatory systems,

  • Increase GRA user adoption of all the technologies allowing them to increase their impacts, leveraging the power of Regulatory Data, Digital and AI capabilities,

  • Ensure the Sanofi RIM backbone and all AI capabilities aligns with the regulations and related Sanofi Responsible AI (RAISE) principles,

MAIN ACTIVITIES

Strategy and roadmap

  • Get the Sanofi Regulatory Data, Digital and AI strategy and roadmap defined, aligned with GRA priorities as well as other business functions at Sanofi (Clinical, PSPV, M&S, Commercial),

Product and project delivery

  • Get the Sanofi Regulatory Data, Digital and AI projects and product roadmap executed, maximizing resources, time, and impact, leveraging Agile methodology,

  • Make all Sanofi Regulatory Data, Digital and AI products and features available to users, based on the right data and RIM software release plan, maximizing software vendor release plan with specific Sanofi needs and project delivery plans,

  • Bring the adequate support (resources, expertise, capabilities, …) into any projects from other functions (Clinical, PSPV, M&S, Commercial, …) using RIM data and software,

Business impact and governance

  • Drive, with Sanofi Digital, the governance and decision process evolving the regulatory data model and RIM features, considering user experience, compliance to regulation, alignment with the Sanofi Digital standards, the RIM software vendors standards & roadmap and impact on dependent system integrations,

  • Measure the user satisfaction and impact on GRA performance of the Digital and AI features and build the related action plans to increase it,

Compliance, security and data quality

  • Track & control the quality of the Regulatory data (completeness, timeliness, consistency) and get the appropriate remediation plans defined with the BPOs and data owners (affiliates, CMC, …)

  • Get the Sanofi Regulatory Data, Digital and AI security strategy defined and executed, allowing to protect Sanofi assets, control sensitive data and secure our commitments with Sanofi partners,

Innovation and technology watch

  • Partner with the Sanofi digital team to get a strong Sanofi Regulatory Data, Digital and AI technology roadmap, with the right vendor engagement model, capabilities, and costs,

  • Align with peers and HA in influencing the RIM software roadmap, to get the RIM vendor roadmap aligned with Sanofi priorities,

Data as a service and data submission

  • Expand the current Sanofi Regulatory Data platform as a service allowing to consume data (system integration, reporting & analytics, AI at scale…)

  • Define the Sanofi data submission strategy and related implementation roadmap (IDMP, Accumulus, …)

  • Deliver the right expertise in terms of Regulatory data, Master Data and RIM data model to all regulatory data consumers,

End user experience and support model

  • Get a Sanofi Regulatory Data, Digital and AI User experience strategy and action plan defined, to increase user adoption and efficiency in using the RIM software,

  • Provide a service to the RIM data owners in terms of data entry, data QC and remediation (mass upload, …)

  • Bring optimized Regulatory data entry and data generation models to all RIM data owners (centralized/decentralized data Mgt models, system integrations, AI generation, …)

  • Maintain the Sanofi Regulatory Data, Digital and AI user support model (resources, expertise, capabilities, …),

  • Track the Digital and AI features user adoption and build the related action plans to increase it,

About you :

Qualifications:

  • A minimum of a Bachelors Degree is required.  MBA Degree is preferred.  A minimum of 15 years of professional business experience is required.  Proven and demonstrated experience in implementing Artificial Intelligence (AI) strategies within a defined roadmap is required. 

  • Experience within a Life Sciences or Pharmaceutical business is preferred. 

  • Formal and demonstrated experience working within a regulatory environment is preferred. 

  • Current or prior experience in leading transformation initiatives is required.  Working experience with Veeva Vault is preferred. 

  • Prior experience in partnering Clinical; PSPV, M&S, and Commercial cross-functional teams is preferred.  This position may require up to 30% overall business travel.

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 and at least 14 weeks’ gender-neutral parental leave.

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.

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