Identify true business needs using a consulting mindset, distinguishing between “need” and “want.”
Gather, analyze, and refine business and functional requirements through stakeholder interviews, workshops, and documentation reviews.
Produce clear, complete, and unambiguous requirements documentation, including functional requirements, user stories, process flows, and acceptance criteria.
Own and maintain requirements traceability matrices (RTMs) to ensure all requirements are fully tested.
Partner with QA, Technology Quality Management, and delivery teams to validate requirements, acceptance criteria, and test scenarios.
Support the definition of User Acceptance Test (UAT) criteria and scenarios and participate in UAT preparation, dry runs, and execution as needed.
Facilitate and co-chair workshops, interviews, and working sessions with cross-functional SMEs and stakeholders.
Drive collaborative agreement, prioritization, and decision-making across business and technology teams.
Communicate effectively with senior stakeholders, sponsors, and functional leaders to align on scope and outcomes.
Act as the primary translator between business stakeholders and engineering teams, ensuring shared understanding of requirements and solution intent.
Serve as the voice of the customer within Scrum or delivery teams when a business SME is not embedded.
Assist in identifying technical capabilities and solution approaches that align with desired business outcomes.
Partner with UX and Human Factors Engineering (HFE) specialists to ensure requirements support intuitive, user-centered solution design.
Apply Business Analysis best practices to continuously improve processes, standards, templates, and ways of working.
Identify opportunities to streamline workflows and improve efficiency while maintaining quality and compliance.
Contribute to the maturity of Business Analysis practices across initiatives and programs.
Requirements
Strong consulting skills, including root cause analysis and the ability to distinguish between true needs and stated wants.
Excellent verbal and written communication skills, with the ability to translate complex discussions into structured documentation.
Proven ability to negotiate, influence, and build consensus with senior stakeholders.
Strong requirements documentation and analytical skills.
Ability to learn new domains quickly and share knowledge effectively across teams.
Ability to work effectively in fast-paced, cross-functional, and globally distributed environments.
Comfortable balancing multiple initiatives and priorities simultaneously.
Experience with generative AI is preferential, including; requirements drafting and refinement, process analysis and optimisation, workshop acceleration, test case support and backlog grooming assistance.
Strong understanding of clinical trials and variations across Phases I–IV.
Solid grounding in Business Analysis best practices and consulting behaviors.
Familiarity with Computer System Validation (CSV), SDLC methodologies, and 21 CFR Part 11 concepts.
Experience working within regulated environments such as pharmaceutical, biotech, or CRO organizations.
Experience supporting project delivery within established Project Lifecycle (PLC) frameworks.
Bachelor’s degree in life sciences, computer science, or relevant discipline required. MSc/MBA/advanced degree preferred.