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- ...Experience writing user stories, functional specifications, test cases, and validation evidence. Familiarity with controlled vocabularies (SPOR, XEVMPD, IDMP preferred). Excellent communication and stakeholder-facing skills. #J-18808-Ljbffr SWITS DIGITAL Private LimitedSuggestedContract work
- JD: Responsibilities Gather and document business and functional requirements for IDMP workstream. Complete the review and approval of all business and functional requirements in ALM. Participate in the updating of the Regulatory Risk Assessments for requirements in collaboration...SuggestedRemote work
- ...Job Posting Responsibilities: Gather and document business and functional requirements for IDMP workstream. Complete the review and approval of all business and functional requirements in ALM. Participate in the updating of the Regulatory Risk Assessments...Suggested
- ...business implications of RIM Suites (e.g., Veeva Vault) Experience of the organizational impact of other significant regulations (e.g., IDMP, EU CTR) Experience in clinical processes, operations and technology (e.g., Veeva, Oracle, Medidata) and the organizational impact...SuggestedLocal areaFlexible hours
- ...reporting. Assist in aligning R&D master data (Product, Study, Molecule, Substance) across Clinical, Safety, and Regulatory systems. 4. IDMP, xEVMPD & Structured Data Across R&D Guide IDMP/SPOR/xEVMPD readiness and implement structured data models that align Regulatory,...SuggestedFull timeTemporary workLocal area
- ...Analyze Veeva releases and roadmap critical features for future adoption. Contribute to structured data submission readiness (gradual IDMP implementation in multiple regions, such as PMS enrichment for Europe). Design enterprise change management frameworks and...Suggested