Business Systems Analyst with Healthcare / Life Sciences

Job Title: Business Systems Analyst (BSA) – Healthcare / Life Sciences

Domain: Healthcare / Pharmaceuticals / Life Sciences (Mandatory)

Job Summary

The successful candidate should have extensive experience in business analysis, requirements gathering, Agile methodologies, and healthcare compliance standards such as GxP, FDA 21 CFR Part 11, GAMP 5, and HIPAA.

Key Responsibilities

Business Analysis & Requirements Management

• Collaborate with business stakeholders to gather, analyze, and document business requirements.
• Conduct stakeholder interviews, workshops, and discovery sessions.
• Analyze existing business processes and identify improvement opportunities.
• Prepare Business Requirement Documents (BRDs), Functional Requirement Documents (FRDs), user stories, use cases, process flows, and acceptance criteria.
• Support backlog refinement and requirement prioritization with Product Owners.

Required Qualifications

• 7+ years of experience as a Business Systems Analyst (BSA) or Business Analyst.
• 3+ years of Healthcare, Pharmaceuticals, Biotechnology, Medical Devices, or Life Sciences experience (Mandatory).
• Strong expertise in requirements gathering, business process analysis, and functional documentation.
• Experience creating:
• BRDs
• FRDs
• User Stories
• Use Cases
• Process Flows
• Functional Specifications
• Experience working in Agile/Scrum environments.
• Strong SDLC knowledge.
• Hands-on experience with:
• Jira
• Azure DevOps
• Confluence
• Experience coordinating SIT and UAT.
• Excellent communication, stakeholder management, and analytical skills.

Healthcare / Life Sciences Experience (Mandatory)

Candidates must have experience with one or more of the following:

• Healthcare
• Pharmaceuticals
• Biotechnology
• Medical Devices
• Clinical Research
• Life Sciences

Must have knowledge of:

• GxP
• FDA 21 CFR Part 11
• GAMP 5
• HIPAA
• Data Integrity
• Computer System Validation (CSV)

Preferred Skills

• Experience with:
• EHR
• LIMS
• ELN
• MES
• ERP
• CRM
• Quality Management Systems (QMS)
• Knowledge of HL7 and FHIR.
• SQL for data analysis and validation.
• API integrations.
• Cloud enterprise applications.
• Digital Transformation projects.
• Power BI or Tableau.
• Business Analysis certifications (CBAP, CCBA, PMI-PBA).
• CSPO or CSM certification is a plus.

Education

• Bachelor''s degree in Computer Science, Information Systems, Healthcare Informatics, Business Administration, Engineering, or a related field.
• Master''s degree preferred.