Job Description

The Identification of Medicinal Products (IDMP) Business Analyst will play a key role in the management and leadership of the European implementation of the ISO Identification IDMP’s standard in our Company. You will be part of a team progressing the strategic, project and operational activities in relation with regulatory data submitted to European authorities, including IDMP/SPOR (European implementation of ISO IDMP), DADI (replacement of the PDF electronic Application Form) and knowledge of XEVMPD ((Extended EudraVigilance Medicinal Product Dictionary, or Article 57) is necessary to properly transition to IDMP from strategic and tactical perspectives. You are also expected to cover several non-EU related topics.

 

Primary Activities include but are not limited to:

XEVMPD Participate, as required, to the internal activities associated with the use of XEVMPD data in the EMEAApply the knowledge of the data requirements and process to the transition to IDMPIDMP Contribute to the development of the IDMP strategy in our Company.  Working with peers across the Company to explain the strategy and integrate the needs and requirements from partner functions across Regulatory and other parts of the companyContribute to the various projects to implement the IDMP strategy in our CompanyWorking with the Business System Owner and IT counterparts and in line with the System Development Life Cycle principlesContribute to the setup and configuration of the IDMP Maintenance and Submission Tool, ensure the proper upload of IDMP data into the tool, define maintenance and submission processes with key stakeholders, and support the roll-out of operational activitiesLead the Data Governance body where cross-functional stakeholders contribute to evolve internal data and systems to converge in line with ISO IDMP and other internal use casesContribute to the evolution of the internal Regulatory Data Hub to ensure alignment with ISO IDMP concepts in line with the IDMP developmentsEnsure synergies with IDMP related topics including XEMVPD and the Digital Application Dataset Integration.Monitor non-EU IDMP-related activitiesReport to the XEVMPD-IDMP Team Lead and Senior Management on the progress of the IDMP program and projectsExternal Activities As the opportunity arises, represent our Company in European Industry Trade Association committees and meeting groups associated with IDMP. Taking on leadership roles within the Trade Association committees and represent the industry in meetings and negotiations with health authorities and other stakeholders

 

Qualifications, Skills & Experience:

Bachelor’s degree in a science or information technology discipline requiredComprehensive experience in Regulatory Affairs or Regulatory OperationsPractical knowledge and experience with ISO IDMP or IDMP/SPORGood understanding of System Development Life Cycle methodology and the requirements for the validation of information management systemsDemonstrated understanding of drug development and execution of regulatory program strategies within the countries and how this impacts regulatory information management strategiesExperience as a leader on cross functional teams been able to influence and motivate team members and Senior Management leading to high quality and on-time delivery of project objectivesDemonstrated situational leadership and creative problem solving within organizations and teamsAbility to prioritize their own work across several ongoing projectsAbility to lead by influence and work effectively in matrix organisational structuresAbility to understand details but keep overall "big picture" view of projects

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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):

Required Skills:

Adaptability, Change Management, Communication, Cross-Cultural Awareness, Data Management, Employee Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking, Systems Development Lifecycle (SDLC), Vendor Management

 Preferred Skills:

Job Posting End Date:

09/8/2025

*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:R361643