RC-REGULATORY COMPLIANCE-Veeva BA-Senior

4 - 7 years

11 - 15 Lacs

bengaluru

Posted:7 hours ago| Platform:

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Skills Required

business transformation analytical consulting workflow life sciences continuous improvement rfp operations information technology auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Your key responsibilities

Gather, analyze, and document business requirements for Veeva Vault implementations (Clinical, RIM, Quality, Safety suite).
Lead workshops for requirements gathering, as-is/to-be process analysis, workflow design, and data mapping between legacy and Veeva systems.
Develop data migration strategies, including field mapping, transformation rules, and validation of migrated data.
Collaborate with technical teams to ensure accurate translation of requirements into Veeva configurations.
Support creation of validation documentation (e.g., URS, FRS, IQ/OQ/PQ) and ensure compliance with GxP and CSV/CSA guidelines.
Facilitate requirement traceability and manage UAT planning and execution using tools like qTest, ALM, and JIRA.
Build dashboards and reports to track progress, risks, and testing outcomes.
Act as a liaison between business and technology teams, driving clarity and alignment on deliverables.
Support business development initiatives, including assisting senior leadership with client pursuits and RFP responses.

Qualifications

Bachelor s degree in computer science, Information Technology, Life Sciences or a related field.
4-7 years of experience as a Business Analyst in IT projects within regulated environments.
Hands-on experience with Veeva Vault applications (Clinical, RIM, Quality, Safety) with demonstrated expertise in related business processes and workflows
Experience working in Agile/Scrum environments, contributing to iterative development and continuous improvement.
Solid understanding of GxP compliance, CSV/CSA methodologies, and 21 CFR Part 11 requirements in validated environments.
Strong analytical and problem-solving abilities, with excellent communication, client interaction, and documentation skills.

Must-Have Skills & Attributes

Proven experience in requirements gathering and documentation using tools like JIRA, Confluence, ALM, Lucid, Visio, Mural, etc.
Familiarity with Veeva Vault configuration concepts (objects, lifecycles, workflows, security roles).
Strong understanding of GAMP 5 methodology, System Development Life Cycle (SDLC), and validation planning
Proficiency in testing and validation tools such as qTest and ALM, with strong dashboarding and reporting capabilities.
Ability to collaborate with cross-functional teams (QA, IT, Manufacturing, Labs, Safety, Regulatory)
Experience in client-facing roles, managing expectations and delivering solutions
Strong communication and presentation skills
Experience in IT project management and validation planning
Familiarity with change control, deviation handling, and CAPA processes
Proven ability to mentor junior resources
Experience in training and cross-skilling resources
Strong teamwork and collaboration mindset
Veeva Vault admin certification

Good-to-Have Skills & Attributes

Exposure to business development activities and client engagement strategies
Exposure to regulatory compliance (FDA, EMA) and audit remediation.
Ability to create innovative insights and contribute to thought leadership
Experience in process optimization and operational efficiency initiatives
Ability to align technology with business transformation goals
High attention to detail and analytical thinking
Adaptability to changing regulatory and business environments
Strong problem-solving and decision-making abilities

A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

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