Veeva Vault Business Analyst

About the job Job Title: Veeva Vault BSALocation: Chicago, ILKey Responsibilities: Gather, analyze, and document business requirements for Veeva Vault implementations and enhancements.Work closely with stakeholders (Quality, Regulatory, Clinical, IT teams) to define system configurations and workflows.Translate business needs into functional and technical requirements.Act as a bridge between business users and technical teams for system development and enhancements.Support system validation, UAT (User Acceptance Testing), and ensure compliance with GxP, CFR Part 11, and regulatory requirements.Develop and maintain system documentation, including SOPs, work instructions, and training materials.Provide ongoing production support, troubleshooting issues, and managing change requests. Required Skills & Experience: Hands-on experience with one or more of the Veeva Vault applications: QualityDocs, eTMF, RIM, PromoMats, or Clinical.Strong experience gathering requirements, writing functional specifications, and supporting system configuration.Ability to manage full lifecycle Veeva Vault projects in regulated industries.Familiarity with GxP, 21 CFR Part 11, FDA, and EMA regulations related to document and data management.Understanding of SaaS platforms, cloud solutions, APIs, integrations, and data migration strategies.Validation & Testing: Experience in CSV (Computer System Validation), UAT, and test case Ability to work with business teams, IT, vendors, and regulatory authorities effectively.Experience in Agile / Scrum / Waterfall methodologies, Jira, Confluence, and Veeva Vault Configuration tools.

Gather, analyze, and document business requirements for Veeva Vault implementations and enhancements. Work closely with stakeholders (Quality, Regulatory, Clinical, IT teams) to define system configurations and workflows. Translate business needs into functional and technical requirements. Act as a bridge between business users and technical teams for system development and enhancements. Support system validation, UAT (User Acceptance Testing), and ensure compliance with GxP, CFR Part 11, and regulatory requirements. Develop and maintain system documentation, including SOPs, work instructions, and training materials. Provide ongoing production support, troubleshooting issues, and managing change requests. Hands-on experience with one or more of the Veeva Vault applications: QualityDocs, eTMF, RIM, PromoMats, or Clinical. Strong experience gathering requirements, writing functional specifications, and supporting system configuration. Ability to manage full lifecycle Veeva Vault projects in regulated industries. Familiarity with GxP, 21 CFR Part 11, FDA, and EMA regulations related to document and data management. Understanding of SaaS platforms, cloud solutions, APIs, integrations, and data migration strategies.Validation & Testing: Experience in CSV (Computer System Validation), UAT, and test case Ability to work with business teams, IT, vendors, and regulatory authorities effectively. Experience in Agile / Scrum / Waterfall methodologies, Jira, Confluence, and Veeva Vault Configuration tools.