Job Overview: We are seeking a Sr. Business Analyst to serve as the bridge between business stakeholders and technical teams by translating Clinical, Quality, and Regulatory requirements into clear, actionable data specifications. This role will partner closely with business users, data engineers, and validation teams to develop complete functional requirements, source-to-target mappings, and data flow documentation that enable efficient solution delivery. The ideal candidate has a strong analytical and data-focused mindset, experience working within regulated life sciences environments, and the ability to convert complex business needs into technically ready requirements that accelerate engineering execution.
Job Responsibilities:
- Collaborate with Quality, Regulatory and clinical business product owners and end users to understand data and analytics requirements
- Craft functional requirements, technical requirements, stage to target mapping documentation
- Analyze and triage the business requirements to understand scope and data sources
- Own the creation of functional requirement document detailing the metrics, KPIs and related data sources as needed by the functional team
- Create data mapping documents and break down epics and user stories for engineering teams
- Collaborate with the overall project manager and reporting workstream lead to manage scope and user feedback
- Collaborate with dev and engineering teams on delivery of data products
- Coordinate with testing and validation teams and manage testing cycles including user acceptance testing. Verify test scripts against the requirements captured
- Assist in implementing data governance standards through data cataloguing, meta data management, defining quality rules, etc.
Job Requirements:
- Bachelor's degree in Business, Computer Science, Life Sciences, Information Systems, or a related discipline
- 5+ years of experience in business and data analysis within the pharmaceutical/biotech industry supporting GxP environments
- Strong knowledge of GxP regulations, including 21 CFR Part 11, with experience supporting Regulatory, Quality, Clinical, and Pharmacovigilance data domains, including clinical operations, patient, QMS, labeling, and reporting data
- Proven ability to partner with business stakeholders to gather, analyze, and translate business and data requirements into implementation-ready Epics, user stories, and technical specifications using Agile methodologies
- Experience with data analysis, SQL querying, reporting, metadata management, data cataloging, and data governance, including familiarity with tools such as Snowflake, Oracle, Power BI, Collibra, and Python
- Hands-on experience with life sciences platforms and project tools, including Veeva Vault applications (QMS, DMS, RIM, EDC, Clinical), Argus, JIRA, ALM, and the Microsoft Office Suite
- Excellent written and verbal communication, analytical, and cross-functional collaboration skills, with the ability to work effectively in a global environment