Lead, Regulatory Data

Job Title: Lead, Regulatory Data

Location: Cambridge, MA, Morristown, NJ

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. 

The Lead, Regulatory Data  is a strong project leader and expert business analyst who can combine consulting, information quality excellence and digital expertise with pharmaceutical and biotechnology regulatory knowledge to drive strategic projects.   

This position will prioritize acquisition projects and be part of the acquistion data migration core team acting as the Migration Lead representing the business.  The Migration Lead role is the business owner for the regulatory data migration at an operational level and ensures the migration goal is planned and executed effectively and in line with Sanofi business rules. Alerts or issues are escalated as appropriate.

This role will be responsible for developing solutions and managing projects to meet current and future data needs including the investigation and analysis of complex regulatory data / document issues.  Based on the investigation and analysis this position will identify root-causes of problems and recommends corrective action as needed.

This management role may oversee onshore, nearshore and offshore, permanent or contractor resources and builds effective partnerships across the Sanofi organization.   This position requires a strong understanding of regulatory data, its business use, Regulatory Information Management (RIM) system data models and the ability to analyze complex sets of data and their relationships, perceiving patterns.    Strong leadership, strategic approach to problem solving, and project management skills are needed for this role along with the ability to collaborate effectively with all users and stakeholders of Sanofi regulatory data.  This role reports to the Sr. Director of Data Readiness and Quality.

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 Responsibilities:

Primary areas of responsibility include:

• The Lead, Regulatory Data role provides leadership, strategy, management oversight, guidance, mentoring and planning for resources, budget and timelines with relation to strategic projects with a focus on migrations as a result of an acquisition.  

• The Lead, Regulatory Data will serve as Migration Lead for specific M&A initiatives as well as maintain oversight over the M&A ways of working to ensure continuous improvemement.  In some instances, the Lead, Regulatory Data may serve as the User Project Lead (UPL), a PUMA role supporting the technical data and content migration.

Migration lead:

• This role will lead and manage at the operational level the business portion of the migration team for acquisitions and ensure the business requirements are met including ensuring business continuity as part of the strategy and planning of migrations.  

• Act as business plan owner for pre-scoping and scoping phase of migration, including the development and management of pre-scoping and scoping phase 

• Identifies data and documentation to be migrated to Sanofi Vault RIM or other systems as appropriate, including the location of the relevant data and documents.

• Leads/facilitates meetings between Sanofi and legacy business SMEs, identifying migration scope and goals via scoping exercises with legacy company.  Liaises with business leads and represents them during Project meetings

• Collaborates with Digital to identify and build Project Team for migration

• Supports the planning and execution of migration as part of the larger project team

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