Specialist, Regulatory Data Stewardship (xevmpd / Idmp)
Merck & Co., Inc., Rahway, New Jersey, USA
Hyderabad, , India
Hybrid
Xevmpd submissions management
Idmp data governance
Evweb and veeva vault rim proficiency
Join a global healthcare biopharma company with a 130-year legacy dedicated to advancing global health through innovative medicines and vaccines
Job Summary
Join a global healthcare biopharma company with a 130-year legacy dedicated to advancing global health through innovative medicines and vaccines.
As a Regulatory Data Steward, you will ensure the quality and regulatory readiness of product registration data impacting life-saving products and compliance with EMA requirements.
The role offers the opportunity to work in a digitally driven environment focused on data, analytics, and insights to support regulatory submissions and business decision-making.
Matching Summary
Join a global healthcare biopharma company with a 130-year legacy dedicated to advancing global health through innovative medicines and vaccines.
Skills & Requirements
Must-have
XEVMPD submissions management
IDMP data governance
EVWEB and Veeva Vault RIM proficiency
Regulatory data quality and compliance
European Medicines Agency reporting
Data migration and enrichment
Nice-to-have
Power BI familiarity
Cross-functional project experience
Effective communication and collaboration
Autonomous and methodical work style
Experience with SharePoint and Microsoft 365 apps
Problem-solving and prioritization skills
Key Requirements
Bachelor’s degree in scientific or IT discipline
Minimum 4 years regulatory affairs or operations experience
Strong knowledge of XEVMPD, IDMP, SPOR, and RIM systems
Understanding of European regulatory framework including SmPC and Module 3
Experience with EVWEB and Veeva Vault RIM
Experience in data migration and enrichment projects