Job Summary The Regulatory RIM Configuration & Managed Services Consultant is responsible for:
- Configuring, administering, and supporting Veeva Vault RIM environments across the Registrations, Submissions, Publishing, and Archive modules for client engagements.
- Delivering implementation, migration, and ongoing managed services support that keeps client RIM environments compliant, reliable, and continuously improved.
- Translating evolving regulatory and eCTD requirements into system configuration changes in partnership with the Regulatory Intelligence Practice Lead.
- Acting as the technical point of contact for client-reported issues, configuration requests, and release management activities.
Essential Functions: Vault Configuration
- Configure and maintain Vault objects: document types, fields, page layouts, picklists, and object hierarchies within Vault RIM.
- Design and configure lifecycle and workflow states, entry/exit actions, user actions, and role-based state transitions.
- Build and maintain security profiles, permission sets, and role-based access matrices within the Vault Admin console.
Data Migration & Integration:
- Support data migration and bulk record management using Vault Loader, including data mapping, transformation, and load validation.
- Configure and maintain Vault-to-Vault and third-party integrations via Vault REST/SOAP APIs and SFTP-based data exchanges (e.g., Safety, Quality, ERP systems).
RIM Module Configuration - Configure RIM Registrations: application/product hierarchies, registration and license record structures, and health authority correspondence tracking.
- Configure RIM Submissions: Submission Content Plans, eCTD lifecycle metadata, sequence structures, and document-to-section mapping.
- Configure RIM Publishing: rendition profiles, binder/output templates, and publishing configuration supporting eCTD and NeeS output.
Release & Environment Management - Manage sandbox refreshes, regression testing, and release notes review for Veeva's biannual release cycles.
- Coordinate user acceptance testing (UAT) and promotion of configuration changes from sandbox to production.
Managed Services & Support - Triage, troubleshoot, and resolve Tier 2/3 support tickets for client-managed RIM environments.
Perform periodic system health checks and proactively identify configuration or performance risks. - Document configuration specifications, business requirements, and SOPs for client-facing and internal use.
- Support end-user training and enablement on Vault RIM functionality.
Necessary Skills and Abilities: - Deep working knowledge of Veeva Vault RIM architecture across Registrations, Submissions, Publishing, and Archive modules.
- Hands-on proficiency configuring Vault objects, page layouts, lifecycles/workflows, and security/role matrices in the Vault Admin console.
- Practical experience with Vault Loader, Vault APIs (REST/SOAP), and structured data migration methodology.
- Working knowledge of eCTD structure (ICH M8) and regional submission requirements (FDA, EMA, Health Canada) as they map to RIM data models.
- Understanding of GxP computer system validation (CSV) principles as applied to configuration changes in a regulated environment.
- Strong troubleshooting and root-cause analysis skills, with the ability to manage support tickets independently.
- Ability to translate client business requirements into clear, testable system configuration specifications.
- Excellent client-facing communication skills; comfortable presenting configuration recommendations directly to client regulatory and IT stakeholders.
- Ability to manage multiple client environments and competing priorities in a consulting/services setting.
Educational Requirements: - Bachelor's degree in Life Sciences, Information Systems, Computer Science, or a related field.
Experience Requirements: - 3-5+ years of hands-on Veeva Vault RIM configuration and/or administration experience, spanning implementation and/or managed services engagements.
- Veeva Vault RIM certification (e.g., Vault Administrator, RIM Configuration, or Vault Platform Administrator) strongly preferred.
- Demonstrated experience supporting at least one full RIM implementation, migration, or major upgrade lifecycle.
- Experience with Vault release management and sandbox-to-production promotion processes.
- Prior consulting, systems integrator, or managed services experience supporting life sciences clients preferred.
This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer.
