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Well help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go.
Join EY and help to build a better working world.
EY GDS Consulting Enterprise Risk (ER) Regulatory Compliance Senior- Business Analyst (Veeva Vault Suite)
At EY were all in to shape your future with confidence.
Well help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world.
As part of our EY-ER- Regulatory Compliance team you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish maintain and strengthen internal and external line with our commitment to quality youll consistently drive projects to completion with high quality deliverables achieve operational efficiency proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.
The opportunity
We are seeking a Senior Business Analyst with strong consulting skills and deep expertise in Veeva Vault applications to support IT implementations in regulated GxP environments. This role focuses on requirements gathering workflow design validation documentation and data migration planning for Veeva-based solutions across the pharmaceutical lifecycle.
Role Overview
As a Business Analyst you will work closely with clients and cross-functional teams to translate business needs into functional specifications lead workshops and ensure compliance with global regulatory standards. You will contribute to projects involving Veeva Vault Clinical RIM Quality and Safety suite enabling successful deployments and integrations within highly regulated environments.
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 :
Bachelors degree in computer science Information Technology Life Sciences or a related field.47 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 workflowsExperience 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 planningProficiency 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 solutionsStrong communication and presentation skillsExperience in IT project management and validation planningFamiliarity with change control deviation handling and CAPA processesProven ability to mentor junior resourcesExperience in training and cross-skilling resourcesStrong teamwork and collaboration mindsetVeeva Vault admin certificationGood-to-Have Skills & Attributes
Exposure to business development activities and client engagement strategiesExposure to regulatory compliance (FDA EMA) and audit remediation.Ability to create innovative insights and contribute to thought leadershipExperience in process optimization and operational efficiency initiativesAbility to align technology with business transformation goalsHigh attention to detail and analytical thinkingAdaptability to changing regulatory and business environmentsStrong problem-solving and decision-making abilitiesWhat we look for
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 industriesWhat working at EY offers
At EY were dedicated to helping our clients from startups to Fortune 500 companies and the work we do with them is as varied as they are.
You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus we offer :
Support coaching and feedback from some of the most engaging colleagues aroundOpportunities to develop new skills and progress your careerThe freedom and flexibility to handle your role in a way thats right for you .EY Building a better working world
EY is building a better working world by creating new value for clients people society and the planet while building trust in capital markets.
Enabled by data AI and advanced technology EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow.
EY teams work across a full spectrum of services in assurance consulting tax strategy and transactions. Fueled by sector insights a globally connected multi-disciplinary network and diverse ecosystem partners EY teams can provide services in more than 150 countries and territories.
Key Skills
Compliance Management,Risk Management,Financial Services,PCI,Banking,Cost Accounting Standards,Quality Systems,Research Experience,NIST Standards,Securities Law,SOX,ISO 27000
Employment Type : Full Time
Experience : years
Vacancy : 1