Regulatory Data Governance (DG) Data Steward

at  Sanofi

SOFT SKILLS:

• Ability to embrace new activities with demonstrated continuous improvement mindset
• Collaborative team player with orientation towards building and maintaining effective relationships, strong culture awareness
• Ability to operate with agility in a dynamic global environment, with multifunctional and multicultural teams
• Ability to propose solutions and proactivity with good organisational skills
• Ability to maintain discretion and confidentiality about sensitive data
• Strive to meet short deadlines and shifting priorities

Technical skills:

• MS Office- Outlook, Excel, Word, PowerPoint & SharePoint
• Veeva Vault is desirable but not essential

Education:

• BSc. in Life Sciences or Regulatory Affairs (or equivalent)

Languages:

• Strong English skills (verbal and written), ability to exchange fluently in a global environment

• Prepare analysis and coordinate with Data Owners, System Owners, vendors, and ITS to investigate and analyse DG Requests, including impacts and related issues resolution
• Ensure implementation of the change directly, or in coordination with ITS
• Enforce and support DG processes & works to ensure DG Requests are resolved, and that the details and decisions are fully documented in the DG request tracker and other reference documentation
• Support system integrations with Regulatory systems, including providing mapping of data between systems and resolution of data related issues between systems
• Govern the data business rules, objects and fields, formats, definitions, and dictionaries, picklists, controlled vocabularies
• With Business Data Owners define & document data model, data formats, and data related business rules
• Maintain Regulatory Information Management (RIM) dictionaries in system, maintain and prepare dictionary content
• Author, maintain and review Data Governance Job Aides describing detailed Data Steward activities
• Promote data literacy and understanding of our data, definitions and standards with Data Owners, Regulatory Affairs, and other Sanofi organizations
• Investigate industry and regulatory standards & requirements related to changes and updates, also data formats and controlled vocabularies