Specialist, Regulatory Data Stewardship (xevmpd / Idmp)

Merck Sharp & Dohme Corp

Hyderabad, India
Hybrid
Xevmpd reporting
Idmp-related data activities
Veeva vault rim
The Regulatory Data Steward is responsible for the governance, quality and regulatory readiness of product registration data used for XEVMPD reporting to the European Medicines Agency (EMA) and for IDMP-related data activities

Job Summary

  • The Regulatory Data Steward is responsible for the governance, quality and regulatory readiness of product registration data used for XEVMPD reporting to the European Medicines Agency (EMA) and for IDMP-related data activities.
  • Manage and deliver XEVMPD submissions for Investigational Medicinal Products and Authorized Medicinal Products via EVWEB and/or Veeva Vault RIM.
  • Join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Matching Summary

The Regulatory Data Steward is responsible for the governance, quality and regulatory readiness of product registration data used for XEVMPD reporting to the European Medicines Agency (EMA) and for IDMP-related data activities.

Skills & Requirements

Must-have

  • XEVMPD reporting
  • IDMP-related data activities
  • Veeva Vault RIM
  • EVWEB
  • European regulatory framework

Nice-to-have

  • data quality projects
  • data catalogue initiatives
  • data marketplace initiatives
  • Power BI
  • intellectually curious

Key Requirements

  • Bachelor’s degree in scientific or IT discipline
  • Minimum 4 years' experience
  • Industry regulatory standards and initiatives experience
  • European regulatory framework understanding
  • Data migration and enrichment projects experience

Work Rights

Not specified

Tailored Resume

Cover Letter