Quick Overview
Seniority
Mid Senior
Work mode
Hybrid
Location
Foster City, CA, United States
Posted
21 hours ago
ScrumAgileContinuous ImprovementStakeholder Management
Job Description
Role Summary
- We are seeking a Business Analyst with hands-on Veeva Vault RIM experience to support our client's Regulatory Affairs technology and process initiatives.
- The role partners with Regulatory Operations, IT, and cross-functional stakeholders to gather requirements, define solutions, and support the delivery, enhancement, and adoption of Veeva Vault RIM capabilities.
Key Responsibilities
- Partner with Regulatory Affairs and Regulatory Operations stakeholders to elicit, document, and validate business requirements for Veeva Vault RIM (Registrations, Submissions, Submissions Archive, Publishing, Submissions Content Plans)
- Translate business needs into clear functional requirements, user stories, acceptance criteria, process flows, and use cases
- Perform gap/fit analysis and recommend configuration vs. customization options within Vault RIM
- Work closely with technical teams, Veeva consultants, and system integrators to support configuration, enhancements, and releases
- Support Veeva's quarterly/general release cycles, including impact assessment, regression and user acceptance testing (UAT), and release communications
- Develop test scenarios and scripts, coordinate UAT, and track defects through resolution
- Support data migration, data mapping, and data quality activities related to RIM initiatives
- Assist with integrations between Vault RIM and other systems (e.g., Vault QualityDocs, Vault Safety, document management, publishing tools, Master Data/IDMP-related sources)
- Create and maintain documentation including SOPs, work instructions, training materials, and validation deliverables in line with GxP and CSV requirements
- Provide end-user support, training, and change management assistance to drive adoption
- Track project status, risks, and issues; communicate progress to stakeholders
- Contribute to continuous improvement of regulatory processes and system capabilities
Required Qualifications
- Bachelor's degree in Life Sciences, Information Systems, Computer Science, or a related field
- 6–8 years of experience as a Business Analyst, with at least 3+ years in the life sciences / pharma / biotech industry
- Hands-on experience with Veeva Vault RIM (Registrations, Submissions, Submissions Publishing, or Archive modules)
- Strong understanding of Regulatory Affairs processes, including global submissions, health authority commitments, and product registration lifecycle
- Experience writing user stories, BRDs/FRDs, and process maps
- Experience with UAT planning and execution in a validated (GxP, 21 CFR Part 11) environment
- Familiarity with SDLC and Agile/Scrum or hybrid delivery methodologies
- Excellent written and verbal communication, facilitation, and stakeholder management skills
- Ability to work independently and manage multiple priorities in a fast-paced environment
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