Business Analyst - Quality, Regulatory and Clinical - Contract jobs in United States
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Vertex Pharmaceuticals · 6 hours ago

Business Analyst - Quality, Regulatory and Clinical - Contract

Vertex Pharmaceuticals is a leading company in the pharmaceutical industry, and they are seeking a Business Analyst for a contract role. The main responsibilities include collaborating with Quality, Regulatory and clinical business product owners to understand data requirements, crafting functional and technical documentation, and managing testing cycles for data products.

BiotechnologyHealth CareMedicalPharmaceutical
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Growth Opportunities
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H1B Sponsor Likelynote

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
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

Qualification

Business analysisData analysisGxP knowledgeAgile methodologyData governanceVeeva QMSSQLPower BIPythonCommunication skills

Required

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
Hands on knowledge with data querying, data analysis, data mining, reporting and analytics will be a plus
Excellent verbal and written communication skills
Willing to work in US EST time zone (half day or more overlap will be preferred)
Tools: Veeva QMS, DMS, Veeva RIM, Veeva EDC, Veeva Clinical, Argus, JIRA, ALM, Power BI, Snowflake, Oracle DB, SQL, Microsoft office suite
Strong foundation in metadata management concepts and data cataloging
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

Benefits

Compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
This role will be eligible for overtime pay, in accordance with federal and state requirements

Company

Vertex Pharmaceuticals

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Vertex Pharmaceuticals is focused on the discovery and development of small molecule drugs for the treatment of serious diseases.

H1B Sponsorship

Vertex Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (188)
2024 (150)
2023 (111)
2022 (164)
2021 (112)
2020 (80)

Funding

Current Stage
Public Company
Total Funding
$657.31M
Key Investors
Janssen Belgium
2024-07-10Post Ipo Secondary· $1.11M
2022-05-17Post Ipo Equity· $50M
2009-12-03Post Ipo Equity· $443M

Leadership Team

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Reshma Kewalramani
CEO and President
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Nina Devlin
Senior Vice President, Chief Communications Officer
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Company data provided by crunchbase