Reglatory Business Analyst

Insight Global; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Insight Global is seeking a Business Analyst to collaborate with Quality, Regulatory and clinical product owners to understand data and analytics requirements in the Pharmaceutical/Biotech sector. You will craft functional and technical requirements, map stages to targets, and own data source documentation.

You will translate requirements into epics and user stories for engineering, coordinate testing cycles, and support data governance through metadata management and data catalogs.

Qualifications

• Experience with Business and data analysis in Pharmaceutical/Biotech Industry in GxP domain.
• Knowledge of 21CFR Part 11 and other GxP governing procedures.
• Collaborate with business product owners and users to understand data and analytics requirements.
• Translate business requirements into implementation-ready Epics and user stories; agile methodologies.
• Familiarity with Data Governance processes and tools such as Collibra.
• Ability to analyze data in the domain to create concise descriptive metadata.
• Proficient in Python and other data analysis tools.

Responsibilities

• Collaborate with Quality, Regulatory and clinical business product owners and end users to understand data and analytics requirements.
• Craft functional and technical requirements, stage-to-target mapping documents.
• Analyze and triage business requirements to understand scope and data sources.
• Own creation of functional requirement documents detailing metrics, KPIs, and data sources.
• Create data mapping documents and break down epics and user stories for engineering teams.
• Coordinate with project manager and reporting lead to manage scope and user feedback.
• Collaborate with dev and engineering teams on delivery of data products.
• Coordinate testing and validation teams and manage testing cycles including UAT; verify test scripts against requirements.
• Assist in implementing data governance standards through cataloguing and metadata management.

Skills

Business data analysis

GxP domain experience

Data governance

Agile / Epics & user stories

Python

Metadata management

Tools

Collibra

Job description

Job Description

We are looking for a BA to:

• 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
• Co-ordinate 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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [e-mail] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

Experience with Business and data analysis in Pharmaceutical/Biotech Industry in GxP domain. Have a great understanding of 21CFRPart 11 and other GxP governing procedures

• Strong understanding of the Regulatory, Quality and Clinical functional areas including experience with clinical operations data, clinical patient data, quality management systems data, Regulatory and labeling data and reporting
• Ability to collaborate with business product owners and users to understand data and analytics requirements
• Strong understanding of agile methodology and ability to convert business requirements into implementation ready Epics and user stories Familiarity with Data Governance processes and tool such as Collibra
• Ability to analyze data in the given domain to create concise descriptive metadata
• Skilled in use of python and other tools for managing the loading and analysis of metadata sets