Senior Business Analyst - Life Science

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Role: Senior Business Analyst (Life Science)

Experience Level: 4 to 7 years

Work location:Bangalore

What you’ll do:  

As a Senior Business Analyst (Life Sciences) in HCLS, you'll be the bridge between complex life sciences business needs and innovative technology solutions. You'll lead requirements gathering, process mapping, and data analysis for projects across the life sciences value chain (e.g., R&D, Clinical Trials, Manufacturing, Commercialization, Regulatory Affairs). Your expertise in life sciences operations, regulatory compliance (e.g., FDA, EMA, GxP), and industry trends will drive the design and implementation of impactful solutions, ensuring alignment with business objectives and delivering measurable value to our clients. You'll mentor junior analysts and champion best practices within the team. 

Role & Responsibilities:

As a Senior Business Analyst specializing in the Healthcare & Life Sciences (HCLS) domain, with a focus on Life Sciences operations, you will play a pivotal role in understanding, analyzing, and translating complex business needs into actionable technology solutions. You will act as a key liaison between business stakeholders, technical teams, and project management, ensuring successful delivery of initiatives that enhance efficiency, compliance, and innovation within the life sciences landscape.

Requirements Elicitation & Analysis:

• Lead and facilitate workshops, interviews, and brainstorming sessions with diverse stakeholders (e.g., R&D scientists, clinical operations, manufacturing, regulatory affairs, commercial teams) to elicit, document, and prioritize detailed business requirements.

• Analyze current state processes, identify pain points, and propose future state solutions, leveraging deep understanding of life sciences operations (e.g., drug discovery, clinical trial management, manufacturing processes, supply chain, pharmacovigilance, commercial launch).

• Translate high-level business needs into clear, concise, and unambiguous functional and non-functional requirements, user stories, use cases, and process flows (BPMN).

Solution Design & Strategy:

• Collaborate with architects, developers, and product owners to design and validate technical solutions that meet business requirements and align with organizational strategy and industry best practices.

• Evaluate potential solutions, including commercial off-the-shelf (COTS) products (e.g., LIMS, CTMS, EDMS, QMS, CRM) and custom development, performing gap analyses and recommending optimal approaches.

• Contribute to the development of business cases, ROI analyses, and project roadmaps.

Life Sciences Domain Expertise & Compliance:

• Apply in-depth knowledge of life sciences regulations (e.g., FDA, EMA, GxP - GLP, GCP, GMP, GDP, GVP, 21 CFR Part 11, ICH guidelines) to ensure all solutions are compliant and mitigate risks.

• Understand and articulate the impact of industry trends such as precision medicine, digital therapeutics, RWE (Real-World Evidence), AI/ML in drug discovery, patient engagement, and supply chain optimization on life sciences operations.

• Provide subject matter expertise on various life sciences segments (e.g., Pharmaceuticals, Biotechnology, Medical Devices, Diagnostics, CROs).

Stakeholder Management & Communication:

• Serve as the primary point of contact for business stakeholders, managing expectations, resolving conflicts, and ensuring alignment throughout the project lifecycle.

• Communicate complex technical concepts to non-technical audiences and business implications to technical teams effectively.

• Prepare and deliver presentations, reports, and documentation to various levels of management and project teams.

Testing & Quality Assurance Support:

• Define acceptance criteria and support the creation of test plans and test cases.

• Participate in user acceptance testing (UAT) and defect triage, ensuring solutions meet business requirements and quality standards.

Documentation & Artifacts:

• Create and maintain comprehensive documentation, including Business Requirements Documents (BRDs), Functional Specification Documents (FSDs), process maps, data flow diagrams, and user manuals.

Must Have Skills:

• Requirements Expertise: Elicitation, documentation, prioritization (JIRA, Azure DevOps, Confluence).

• Process Modeling: Current/future state, optimization (BPMN, Visio, Lucidchart).

• Data Analysis: Advanced SQL, Data Visualization (Tableau, Power BI, Qlik Sense).

• Life Sciences Domain Knowledge: Strong understanding of at least two areas: R&D (e.g., drug discovery, preclinical), Clinical Trials (e.g., CTMS, EDC), Manufacturing (e.g., MES, LIMS), Regulatory Affairs (e.g., EDMS, RIM), Commercial (e.g., CRM, SFE), or Pharmacovigilance.

• Regulatory Compliance: GxP (GLP, GCP, GMP), 21 CFR Part 11, ICH guidelines, FDA/EMA regulations.

• Technical Acumen: API concepts, system integration patterns, database fundamentals, understanding of cloud platforms (AWS, Azure, GCP).

• Testing Support: Acceptance criteria definition, UAT coordination, test case review.

• Documentation: Comprehensive project artifacts (BRDs, FSDs, SOPs).