Duration: 7.5 months (till June 30th, 2022)
Start Date: 2021-11-15
Scheduled End: 2022-06-30
Employment Type: Contract
Experience Level: 2 – 5
Regulatory Data Governance (DG) Data Steward:
– The Regulatory Data Governance (DG) Data Steward is responsible for driving Data Governance Requests to completion for changes to Regulatory data, formats, standards and controlled vocabularies within Regulatory systems. Including full impact analysis of changes including impact on related systems and projects.
– Coordinates with Data Owners, System Owners, vendors, ITS, and Data Governance teams to investigate and analyze the request, impacts and related issues.
– Prepares analysis for Data Owners, & works together to resolve DG Request. The Data Steward is responsible to ensure implementation of the change by implementing the change directly, or in coordination with ITS.
– Monitors regulatory & industry standards for changes and updates.
– Enforces and Supports DG processes & works to ensure DG Requests are resolved, and that the details are fully documented in the DG request tracker and other reference documentation.
– Works to ensure quality, compliance, and operational efficiency.
– Supports system integrations with Regulatory systems, including providing mapping of data and terminologies between systems and resolution of data related issues between systems.
– Governs the data business rules, objects and fields, formats, definitions, and dictionaries, picklists, controlled vocabularies.
– Promotes data literacy and understanding of our data, definitions and standards with Data Owners, Regulatory Affairs, and other Sanofi organizations.
– Governs and supports business data models, data flows and data lineage mapping for Sanofi's Regulatory data.
– Investigates industry and regulatory standards & requirements related to data formats and controlled vocabularies.
– Works to ensure Regulatory data formats & dictionaries stay current and compliant.
– With Business Data Owners defines & documents data model, data formats, and data related business rules.
– Maintains Regulatory Information Management (RIM) dictionaries in system. Documents DG recommendations and decisions for DG Requests, and maintains DG documentation.
– Maintains and prepares documentation of RIM dictionary content. This documentation used for traceability, audits, and for QC of the RIM database configuration.
– Authors, maintains and reviews Data Governance Job Aides describing detailed Data Steward activities.
– High attention to detail
– Excellent documentation and communication skills are critical
– Good presentation skills
– Experience and understanding of the importance of data quality
– Self-driven, conscientious and able to work within a collaborative work environment
– Familiarity with ITS service/ticket systems
– Background in Pharmaceutical Regulatory Affairs and Quality Operations
Education – Bachelor's Degree in Science (BSc.), Pharmaceutical Regulatory
4-6 years' experience in an analyst role/function
Pharmaceutical Regulatory Affairs
Experience with Pharmaceutical Regulatory Data and standards needed
ALTEN PROEX is a Canadian Engineering and Technology Consulting Services company, and a subsidiary of ALTEN Group. Within 30 years, ALTEN has become leader in R&D, Engineering, Information Technology Services, Life Sciences and Network Services with 37,000 consultants working in more than 20 countries.
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