Regulatory RIM Business Analyst & Managed Services Consultant

Summary

Slipstream Life Sciences provides IT support, managed solutions, and strategic consulting services for emerging pharmaceutical and biotechnology organizations. The Regulatory RIM Business Analyst & Managed Services Consultant configures, administers, and supports Veeva Vault RIM environments across Registrations, Submissions, Publishing, and Archive, while delivering implementation, migration, release management, and ongoing managed services support.

Responsibilities

• 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
• 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
• 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)
• 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
• 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
• 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

Skills

• 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
• Bachelor's degree in Life Sciences, Information Systems, Computer Science, or a related field
• 3-5+ years of hands-on Veeva Vault RIM configuration and/or administration experience, spanning implementation and/or managed services engagements
• 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
• Veeva Vault RIM certification (e.g., Vault Administrator, RIM Configuration, or Vault Platform Administrator) strongly preferred
• Prior consulting, systems integrator, or managed services experience supporting life sciences clients preferred

Qualifications

Must Haves

• 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
• Bachelor's degree in Life Sciences, Information Systems, Computer Science, or a related field
• 3-5+ years of hands-on Veeva Vault RIM configuration and/or administration experience, spanning implementation and/or managed services engagements
• 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

Nice to Haves

• Veeva Vault RIM certification (e.g., Vault Administrator, RIM Configuration, or Vault Platform Administrator) strongly preferred
• Prior consulting, systems integrator, or managed services experience supporting life sciences clients preferred