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
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.
Requisition ID: R319127
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