Idmp Associate Director, Reg. Affairs

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 EMEA.
  • Apply the knowledge of the data requirements and process to the transition to IDMP.

• IDMP
  • 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 company.
  • Contribute to the various projects to implement the IDMP strategy in our Company.
  • Working with the Business System Owner and IT counterparts and in line with the System Development Life Cycle principles.
  • Contribute 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 activities.
  • 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.
  • Contribute to the evolution of the internal Regulatory Data Hub to ensure alignment with ISO IDMP concepts in line with the IDMP developments.
  • Ensure synergies with IDMP related topics including XEMVPD and the Digital Application Dataset Integration.
  • Monitor non-EU IDMP-related activities.
  • Report to the XEVMPD-IDMP Team Lead and Senior Management on the progress of the IDMP program and projects.

• External 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 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 been able 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 their own work across several ongoing projects.
• Ability to lead by influence and work effectively in matrix organizational structures.
• Ability to understand details but keep overall "big picture" view of projects.

Desired Experience and Skills

• Good knowledge of XEVMPD/Article 57, possibly with experience in implementing or supporting reporting tools and processes
• Expertise in project management methodologies and associated toolsets.
• Advanced degree preferred (engineering or scientific discipline, MBA).

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R276012