Overview
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) to properly transition to IDMP from strategic and tactical perspectives. You are also expected to cover several non-EU related topics.
Responsibilities
* XEVMPD
o Participate, as required, in the internal activities associated with the use of XEVMPD data in the EMEA
o Apply knowledge of the data requirements and processes to the transition to IDMP
* IDMP
o Contribute to the development of the IDMP strategy in our Company. Work 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 company
o Contribute to various projects to implement the IDMP strategy in our Company
o Work with the Business System Owner and IT counterparts in line with the System Development Life Cycle principles
o Contribute to the setup and configuration of the IDMP Maintenance and Submission Tool, ensure proper upload of IDMP data into the tool, define maintenance and submission processes with key stakeholders, and support the roll-out of operational activities
o Lead 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 cases
o Contribute to the evolution of the internal Regulatory Data Hub to ensure alignment with ISO IDMP concepts in line with the IDMP developments
o Ensure synergies with IDMP-related topics including XEMVPD and the Digital Application Dataset Integration
o Monitor non-EU IDMP-related activities
o Report to the XEVMPD-IDMP Team Lead and Senior Management on the progress of the IDMP program and projects
* External Activities
o As opportunities arise, represent our Company in European Industry Trade Association committees and meeting groups associated with IDMP. Take on leadership roles within 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 required
* Comprehensive experience in Regulatory Affairs or Regulatory Operations
* Practical knowledge and experience with ISO IDMP or IDMP/SPOR
* Good understanding of System Development Life Cycle methodology and the requirements for the validation of information management systems
* Demonstrated understanding of drug development and execution of regulatory program strategies within the countries and how this impacts regulatory information management strategies
* Experience as a leader on cross-functional teams and the ability to influence and motivate team members and Senior Management leading to high quality and on-time delivery of project objectives
* Demonstrated situational leadership and creative problem solving within organizations and teams
* Ability to prioritize own work across several ongoing projects
* Ability to lead by influence and work effectively in matrix organizational structures
* Ability to understand details but keep the overall "big picture" view of projects
Required Skills
* Accountability
* Adaptability
* Business Processes
* Change Management
* Clinical Trial Agreements (CTA)
* Clinical Trials
* Communication
* Cross-Cultural Awareness
* Data Management
* Employee Training Programs
* FDA Regulations
* Global Health
* Internal Processes
* Management Process
* Mentorship
* Pharmacovigilance
* Policy Implementation
* Project Management
* Regulatory Affairs Management
* Regulatory Compliance
* Regulatory Labeling
* Regulatory Submissions
* Stakeholder Management
Preferred Skills
Current Employees apply HERE
Current Contingent Workers apply HERE
Other Information
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: 11/10/2025
*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.
#J-18808-Ljbffr