IDMP Senior Specialist

Merck Gruppe - MSD Sharp & Dohme • Rahway, NJ, United States • $200k - $250k / year • 3w ago

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.
Participate in the global initiative to expand internal source systems to become compliant with IDMP in the EU, as well as PQ/CMC in the US, and to enhance interoperability across these systems using ISO IDMP.
Participate in the setup of a central group to manage IDMP-related data to support Regulatory Affairs activities in the 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.
Experience with 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

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Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements: Hybrid

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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.

Requisition ID: R319127

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