• Job Description

  Req#: R319127

  Job Description

  Do you have a passion for driving business excellence in the pharmaceutical industry? We're seeking a talented IDMP (Identification of Medicinal Products) Business Analyst to play a key role in ensuring compliance with Article 57 of EU Regulation 1235/2010 (XEVMPD/IDMP) within Regulatory Affairs Operations (RRO) – EMEA.

  Key Responsibilities:

  • Coordinate activities to ensure IDMP readiness and compliance with European regulatory requirements
  • Contribute to the definition of future state IDMP processes and enhance XEVMPD solutions within the company
  • Collaborate on global initiatives to expand internal source systems and improve interoperability using ISO IDMP as a common language
  • Participation to the global initiative to expand internal source systems, to become compliant with IDMP in the EU, as well as PQ/CMC in the US. Another objective is to expand the interoperability across these systems, using ISO IDMP as a common language
  • Participation to the setup of a central group to manage IDMP-related data to support Regulatory Affairs activities in scope of the Application Form /PLM , IDMP/SPOR, and other EMA systems

  Qualifications and Requirements:

  • Strong understanding of regulatory affairs in the pharmaceutical industry, specifically in relation to IDMP and XEVMPD requirements
  • Master data management experience
  • Understanding of governance and project management
  • Veeva or similar complex RIM Implementation
  • Experience in coordinating cross-functional projects and initiatives
  • Excellent communication and interpersonal skills

  This is an exciting opportunity to drive impactful change and advance regulatory compliance in a dynamic and collaborative environment.

  Closing date for applications: 15th November 2024

  Current Employees apply HERE

  Current Contingent Workers apply HERE

  Search Firm Representatives Please Read Carefully
  Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

  Employee Status:

  Regular

  Relocation:

  VISA Sponsorship:

  Travel Requirements:

  Flexible Work Arrangements:

  Hybrid

  Shift:

  Valid Driving License:

  Hazardous Material(s):

  Job Posting End Date:

  11/15/2024

  *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

• About the company

  Merck & Co., Inc.,

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