Specialist, Regulatory Data Stewardship (xevmpd / Idmp)

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

Hyderabad, India
Hybrid
Xevmpd
Idmp
Regulatory data management
The Specialist, 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 Specialist, 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 Specialist, 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
  • IDMP
  • Regulatory data management
  • Veeva Vault RIM
  • EVWEB

Nice-to-have

  • Data quality initiatives
  • Data catalogue projects
  • Data marketplace projects
  • Microsoft 365 apps
  • Power BI

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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