Specialist, Regulatory Data Stewardship (xevmpd / Idmp)
Merck & Co., Inc., Rahway, New Jersey, USA
Hyderabad, India
Hybrid
Xevmpd reporting
Idmp-related 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-related data activities
EVWEB and Veeva Vault RIM
European regulatory framework
data migration and enrichment
Nice-to-have
passion for regulatory data management
digital technology and data-backed approaches
intellectually curious
empathy, creativity, digital mastery
Key Requirements
Bachelor’s degree in scientific or IT discipline
Minimum 4 years’ experience
Strong working knowledge of industry regulatory standards
Good understanding of European regulatory framework