Position: Regulatory Business Analyst
Location: Hybrid – Boston, MA
Duration: 3+ Month Contract
Business analyst supporting Regulatory, Quality, and Clinical functions in a GxP environment. Gathers and documents functional and technical requirements, builds data mapping and stage-to-target documentation, breaks down epics and user stories for engineering teams, and coordinates validation and user acceptance testing. Requires working knowledge of 21 CFR Part 11 and GxP governing procedures, plus hands-on experience with Veeva (RIM, QMS, DMS, EDC, Clinical), Argus, JIRA, Power BI, Snowflake, and SQL.
Responsibilities
- Collaborate with Quality, Regulatory, and Clinical business product owners and end users to understand data and analytics requirements.
- Craft functional requirements, technical requirements, and stage-to-target mapping documentation.
- Analyze and triage business requirements to understand scope, dependencies, and data sources.
- Own the creation of functional requirements documents detailing metrics, KPIs, business rules, and related data sources as needed by functional teams.
- Create data mapping documents and break down epics into implementation-ready user stories for engineering teams.
- Collaborate with the overall Project Manager and reporting workstream lead to manage scope, priorities, and user feedback.
- Collaborate with development and engineering teams on the delivery of data products.
- Coordinate with testing and validation teams and manage testing cycles, including User Acceptance Testing (UAT).
- Verify test scripts against documented business and functional requirements.
- Assist in implementing data governance standards through data cataloging, metadata management, data quality rules, and related governance processes.
Skills and Experience- Experience with business and data analysis within the Pharmaceutical/Biotech industry and GxP environments.
- Strong understanding of 21 CFR Part 11 and other applicable GxP governing procedures and compliance requirements.
- Strong understanding of Regulatory, Quality, and Clinical functional areas, including clinical operations data, clinical patient data, Quality Management System (QMS) data, Regulatory and labeling data, and reporting.
- Ability to collaborate effectively with business product owners, subject matter experts, and end users to understand data and analytics requirements.
- Strong understanding of Agile methodology and the ability to translate business requirements into implementation-ready epics, user stories, and acceptance criteria.
- Tools: Veeva QMS, DMS, Veeva RIM, Veeva EDC, Veeva Clinical, Argus, JIRA, ALM, Power BI, Snowflake, Oracle DB, SQL, Microsoft office suite
- Hands-on knowledge of data querying, data analysis, data mining, reporting, and analytics is a plus.
- Excellent verbal and written communication skills.
- Willingness to work in the US EST time zone, with half-day or greater overlap preferred.
Data Governance & Metadata- Strong foundation in metadata management concepts and data cataloging.
- Familiarity with data governance processes and tools such as Collibra.
- Ability to analyze data within the relevant business domain and create concise, descriptive metadata.
- Skilled in Python and other tools for managing, loading, transforming, and analyzing metadata datasets.