What are the responsibilities and job description for the IDMP Business Analyst position at Tektree Systems Inc.?
Job Details
Must Have's:
Veeva RIM, IDMP (Identification of Medicinal Products)
Candidate must understand implementation of IDMP using Veeva RIM
10 years
Regulatory/ Clinical domain
Some clients call this role a PM, but BA is the primary function
The Identification of Medicinal Products (IDMP) Business Analyst 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.
