Veeva Vault RIM SME / Lead Consultant

Job Description: Veeva Vault RIM SME / Lead Consultant

Job Details

• Job Title: Veeva Vault RIM Lead / SME

• Location: Cambridge, ME

• Duration: 6 months

• Experience Required: 10+ years

• Primary Skills: Veeva Vault Platform, Veeva CRM

Role Description

• Lead the implementation, configuration, and support of the Veeva Vault RIM Suite, including:

  • Registrations

  • Submissions

  • Submissions Archive

  • RegulatoryOne

• Collaborate with Regulatory Affairs, Clinical, Quality, and IT teams to gather business requirements and translate them into scalable Veeva RIM solutions.

• Manage the end-to-end lifecycle of global regulatory submissions, registrations, renewals, variations, and health authority correspondence within Veeva Vault RIM.

• Configure and maintain Veeva objects, document types, lifecycles, workflows, security roles, metadata, and reporting capabilities.

• Lead regulatory data migration from legacy systems to Veeva Vault RIM, ensuring data accuracy, completeness, and compliance.

• Support integrations between Veeva RIM and enterprise platforms, including:

  • Veeva Quality

  • Veeva Safety

  • Veeva Clinical

  • SAP and other ERP systems

  • Documentum

  • Other regulatory repositories

• Develop and execute system validation deliverables, including:

  • User Requirements Specification (URS)

  • Functional Specification (FS)

  • Requirements Traceability Matrix (RTM)

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Testing documentation

• Ensure compliance with GxP, FDA 21 CFR Part 11, EMA guidelines, and global regulatory requirements.

• Analyze regulatory operations processes and recommend automation, standardization, and continuous improvement initiatives.

• Provide production support, troubleshoot issues, manage releases, and deliver user training.

• Ensure adherence to Service Level Agreements (SLAs) and regulatory governance standards.

• Act as a Subject Matter Expert (SME) for Veeva RIM, advising stakeholders on best practices, regulatory data management, system enhancements, and future roadmap initiatives.

Essential Technical Skills

• Veeva Vault RIM implementation and configuration.

• Veeva Vault Registrations and Submissions.

• Veeva Submissions Archive and RegulatoryOne.

• Regulatory Affairs and global regulatory submission management.

• Regulatory registrations, renewals, variations, and health authority correspondence.

• Veeva Vault objects, document types, lifecycles, workflows, and metadata configuration.

• Security roles, access controls, and reporting.

• Regulatory data migration and data quality management.

• Enterprise system integration and interface support.

• Veeva Quality, Safety, and Clinical integrations.

• SAP, ERP systems, and Documentum integration.

• GxP compliance and FDA 21 CFR Part 11.

• System validation, URS, FS, RTM, IQ/OQ/PQ, and testing.

• Production support, release management, troubleshooting, and user training.

• Regulatory process automation and continuous improvement.

Desirable Skills

• Veeva Vault Platform.

• Veeva CRM.

• Regulatory data management.

• Pharmaceutical and life sciences regulatory systems.

• Global regulatory compliance and governance.

• Stakeholder management and cross-functional collaboration.