Job Title: Business Analyst – Life Sciences (Product Development)
Experience Required: 2-3 years
Location: Hyderabad-Onsite
Employment Type: Full-time
Job Summary
We are looking for a Business Analyst to lead requirements discovery, documentation, and product alignment for our clinical platform. You will work closely with product owners, domain experts, developers, QA, and cross-functional clinical teams (Clinical Operations, Data Management, Biostatistics, and Regulatory) to understand business processes and translate stakeholder needs into clear, testable requirements and user stories that drive high-quality product delivery.
Key Responsibilities
- Engage with stakeholders, product managers, and SMEs to elicit, analyse, and document business and functional requirements.
- Create and maintain BRDs/FRDs, user stories, use cases, process flows, wireframe notes (as needed), and acceptance criteria.
- Perform gap analysis, impact analysis, and support requirements prioritization with stakeholders.
- Partner with Engineering, QA, and UI/UX teams throughout the product development lifecycle to clarify requirements and resolve ambiguities.
- Support sprint planning, backlog grooming, and feature refinement in Agile/Scrum environments.
- Validate delivered features against requirements; support UAT planning, test case review, execution, defect triage, and closure.
- Ensure requirements align with applicable industry standards and regulatory expectations (e.g., GxP, 21 CFR Part 11, ICH-GCP; as relevant to product).
- Conduct requirements risk analysis (functional, compliance, data integrity, patient safety, security, operational) and document mitigations; escalate high-risk items early.
- Perform impact and change-risk assessments for new features/enhancements, including downstream effects on workflows, integrations, validation, and releases.
- Analyze customer challenges in pharma/biotech/clinical research and translate insights into product enhancements and roadmap inputs.
- Develop as-is/to-be process maps and recommend process improvements aligned with product and user goals.
- Support analysis of KPIs/metrics, reporting requirements, and usability improvements to drive adoption and efficiency.
- Prepare product demos, functional walkthroughs, release notes inputs, and training/UAT support materials.
- Maintain documentation hygiene: timely updates, version control, traceability, and proactive stakeholder communication.
Required Skills & Qualifications
- Bachelor’s degree in Life Sciences, MBBS, Pharmacy, Biotechnology, or related field; MBA or equivalent is a plus.
- At least 1 year of experience as a Business Analyst in product development within the life sciences domain.
- Hands-on experience writing user stories + acceptance criteria and managing backlogs (Jira/ADO).
- Excellent documentation skills: BRD/FRD/SRS, workflows, RTM (Requirements Traceability Metics), UAT documents.
- Strong understanding of pharma R&D, clinical workflows, regulatory processes, or related functional areas.
- Experience in documenting compliance-related requirements (21 CFR Part 11,HIPAA, GxP, etc.).
- Proficiency in tools such as Azure DevOps, Visio, or similar.
- Ability to create detailed functional specifications and user stories.
- Strong analytical, documentation, and problem-solving skills.
- Excellent communication and stakeholder management abilities.
Skills: rtm,jira,brd/frd/srs,life sciences,cfr,product development,ado,uat coordination
