Specialist, Regulatory Data Stewardship (xevmpd / Idmp)

Merck & Co., Inc., Rahway, New Jersey, USA

Hyderabad, India
Hybrid
Xevmpd reporting
Idmp data activities
Evweb and 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.
  • Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products.

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 data activities
  • EVWEB and Veeva Vault RIM
  • European regulatory framework
  • data migration and enrichment

Nice-to-have

  • passion for regulatory data
  • digital technology and data-backed approaches
  • collaboration and best practices
  • intellectually curious

Key Requirements

  • Minimum 4 years’ experience
  • Bachelor’s degree in scientific or IT discipline
  • Experience in Regulatory Affairs or Regulatory Operations
  • Strong working knowledge of XEVMPD/EVPRM, ISO IDMP, SPOR
  • Good understanding of SmPC / Module 3

Work Rights

Not specified

Tailored Resume

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