What are the responsibilities and job description for the Identification of Medical Products (IDMP) Specialist position at Trigent Software?
Title : Identification of Medicinal Products (IDMP) Specialist
Location : Chicago, IL
Duration : 12 Months (Possible Extension / FTE)
Summary :
The Identification of Medicinal Products (IDMP) Specialist will hold an essential position in managing and leading the European rollout of the ISO Identification IDMP's standard within our Company. You will join a team advancing the strategic, project, and operational efforts related to regulatory data submitted to European authorities, encompassing IDMP / SPOR (European implementation of ISO IDMP), DADI (the substitute for the PDF electronic Application Form), and familiarity with XEVMPD (Extended EudraVigilance Medicinal Product Dictionary, or Article 57) is crucial for effectively transitioning to IDMP from both strategic and tactical viewpoints. You are also anticipated to address several non-EU related subjects.
Responsibilities :
- IDMP Strategy Development : Assist in formulating and implementing the IDMP strategy within the organization.
- Data Management : Ensure accurate uploading and maintenance of IDMP data into relevant tools and systems.
- Project Coordination : Collaborate with cross-functional teams to implement IDMP-related projects, adhering to the System Development Life Cycle (SDLC) principles.
- Regulatory Compliance : Manage and lead the European rollout of the ISO IDMP standard, ensuring compliance with regulatory requirements.
- Stakeholder Engagement : Work with internal and external stakeholders to clarify and incorporate their needs into the IDMP strategy.
- Data Governance : Lead the Data Governance committee to enhance internal data and systems in accordance with ISO IDMP standards.
- Operational Support : Support the establishment and configuration of IDMP Maintenance and Submission Tools, and assist in executing operational tasks.
- Communication : Report progress and updates to senior management and the IDMP team lead.
Required qualifications to be successful in this role :
This role is essential for ensuring that the organization meets regulatory standards and effectively manages medicinal product data.
