Business Analyst - Qual, Reg, and Clinical

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.
• 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.
• Aid in implementing data governance standards through data cataloging, metadata management, data quality rules, and related governance processes.

Requirements

• 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.

Qualifications

• 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.