Role Summary -
The IDMP Data Steward is responsible for ensuring the accuracy, completeness, consistency, and regulatory compliance of Product Master Data aligned to ISO IDMP standards (ISO 11615, 11616, 11238, 11239, 11240). The role acts as the operational custodian of regulated product data across MDM and source systems, supporting global regulatory submissions and ongoing data governance.
Key Responsibilities -
IDMP Product Data Stewardship
• Own and maintain IDMP-compliant Product Master Data across regulated medicinal product domains (MP, PhPID, substance, packaging, dosage form, route, units of measurement).
• Perform data creation, enrichment, validation, remediation, and lifecycle management in the MDM platform.
• Ensure alignment of product data with SPOR (RMS, OMS, PMS, SMS) reference data.
Data Quality & Compliance
• Execute data quality checks, profiling, matching, and issue resolution to meet regulatory-grade data quality standards.
• Monitor and resolve data discrepancies across upstream and downstream systems
• Support audit readiness by maintaining traceability, completeness, and controlled change history for IDMP data.
Regulatory & Submission Support
• Support preparation of IDMP message files and data packages for regulatory submissions and third party gateways (e.g., EMA, FDA).
• Collaborate with Regulatory Operations and RIM teams to ensure submission ready, validated product data.
Cross Functional Collaboration
• Act as the bridge between business, regulatory, and IT teams for IDMP data topics.
• Support data mapping, data migration, and onboarding of new source systems into the IDMP MDM landscape
Required Skills & Experience -
• Strong understanding of ISO IDMP standards and regulated product master data.
• Hands on experience in MDM / Product Information Management (PIM) environments.
• Familiarity with SPOR data domains and regulatory data governance concepts.
Technical
• Experience working with MDM tools
• Ability to analyze, validate, and troubleshoot complex product data across multiple systems.
• Exposure to RIM systems and regulatory submission processes.
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