IDMP Senior Specialist
IDMP Senior Specialist
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Job Description
Job Description
Do you have a passion for driving business excellence in the pharmaceutical industry Were 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
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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability Audits Compliance Communication Detail-Oriented Drug Regulatory Affairs Employee Training Programs Global Communications Management Process Pharmaceutical Regulatory Affairs Pharmacovigilance Process Improvements Project Management Regulatory Affairs Compliance Regulatory Affairs Management Regulatory Compliance Regulatory Operations Regulatory Strategy Development Regulatory SubmissionsPreferred Skills:
Job Posting End Date:
09/8/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Senior IC
Employment Type
Full-Time
