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- 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
- ...Develop and enforce user access governance across all RIM modules: Submissions, Submissions Archive, Registrations including xEVMPD/IDMP Manage lifecycle state security and record level access controls within Vault RIM Design and implement security models for managing...SuggestedWeekly payTemporary workRemote workFlexible hours
- ...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
- ...training for data producers/consumers* Ensure practices reflect relevant regulatory and industry standards (GxP, 21 CFR part 11, ICH, IDMP, WHO Drug Dictionary) and maintain up-to-date knowledge of nomenclature and data standards* Preserve confidentiality and adhere to...SuggestedLocal area
- ...management practices, and experience working with regulatory stakeholders. Familiarity with regulatory standards and frameworks such as IDMP, SPOR, eCTD, or structured regulatory content management. Understanding of enterprise data architectures, system integrations, and...SuggestedWork at officeLocal areaWork from homeWorldwideFlexible hours
$125k - $300k
...Veeva Regulatory." You will speak at key conferences such as Veeva Summit and DIA to shape the industry's conversation around RIM AI, IDMP, eCTD, and data governance. Be the voice of the customer for our Product and Engineering teams. You tell them what the industry...SuggestedRemote jobWork at officeLocal areaWork from homeFlexible hours- ...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
- ...translate requirements into solutions Preferred technical and professional experience Experience with advanced RIM capabilities: XEVMPD/IDMP concepts Knowledge of global regulatory standards and formats: eCTD, IDMP Experience with data migration and large‑scale RIM...SuggestedWorldwide
- ...Life Science) Location: Princeton, NJ Experience : 6+ Gather and document business and functional requirements for IDMP Wave 2a. Complete the review and approval of all business and functional requirements in ALM. Participate in the updating of...Suggested
- ...landscapes Defining and executing Grünenthal’s regulatory data strategy to ensure compliance with evolving global regulations (e.g. IDMP, ESMP, eCTD 4.0) Leading vendor selection, performance management, and external partnerships for GRA digital solutions and operations...SuggestedPermanent employmentFull timeContract workWork at office
