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Diverse Lynx

Business Analyst - Regulatory Information Management Systems (RIMS)

Diverse Lynx, San Jose, California, United States, 95199

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Job Title: Business Analyst - Regulatory Information Management Systems (RIMS)Location: San Jose, CADuration: ContractRole Description:Serve as the primary liaison between regulatory and IT teams, responsible for gathering, documenting, and validating business requirements related to RIMS enhancements and integrations. Oversee system validation, coordinate User Acceptance Testing (UAT), and maintain compliance documentation. Manage vendor relationships and ensure offshore teams meet SLAs and KPIs. Ensure adherence to regulatory frameworks such as GxP, 21 CFR Part 11, and IDMP. Participate in audits and inspections by providing thorough system documentation and traceability. Lead project planning, monitoring, status reporting, and support change management and training initiatives.Key Competencies: Digital Enterprise Integration Regulatory compliance and validation Vendor and stakeholder management Agile and hybrid project methodologiesDiverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.