Business Analyst, AI Data & Content Generation

Title: Business Analyst, AI Data & Content Generation

We have partnered with our client in their search for an experienced Business Analyst to support the design and implementation of an AI-enabled data and content-generation solution within a regulated life-sciences environment.

This individual will serve as a critical link between business stakeholders, regulatory content owners, IT teams, solution architects, developers, and consulting partners. The Business Analyst will lead requirements gathering, process analysis, solution planning, and implementation support for a platform involving regulatory documents and content such as protocols, Clinical Study Reports, and related deliverables.

The ideal candidate brings a combination of strong business analysis capabilities, experience with regulated clinical or regulatory content, and familiarity with enterprise technology integrations. Experience integrating applications with Veeva RIM or a comparable regulatory information management platform is particularly valuable.

Responsibilities

• Lead requirements gathering sessions with regulatory, clinical, medical writing, IT, architecture, and development stakeholders.
• Translate business needs into clear functional requirements, user stories, process flows, acceptance criteria, and solution documentation.
• Partner with business users responsible for regulatory content, including protocols, Clinical Study Reports, and related regulated deliverables.
• Document current-state and future-state business processes associated with content creation, review, approval, management, and system integration.
• Identify business, process, data, integration, and compliance requirements for the AI-enabled solution.
• Facilitate workshops and working sessions involving both technical and nontechnical stakeholders.
• Support the design and implementation of integrations between the new solution and enterprise platforms such as Veeva RIM.
• Work closely with solution architects and developers to clarify requirements, resolve questions, and maintain alignment between the proposed design and business needs.
• Help define data inputs, content sources, workflows, business rules, metadata, and expected outputs for AI-assisted content generation.
• Support backlog development and refinement within an Agile or iterative delivery model.
• Coordinate business review and approval of requirements, designs, prototypes, and completed functionality.
• Develop test scenarios and support system testing, integration testing, and user acceptance testing.
• Track requirements through design, development, testing, and deployment to maintain end-to-end traceability.
• Identify requirement gaps, dependencies, risks, and decisions requiring stakeholder alignment.
• Collaborate effectively with multiple consulting firms operating in a co-development environment.
• Support implementation readiness, business communications, training, and transition activities as needed.

Skills Required

• Demonstrated experience as a Business Analyst on complex technology implementation initiatives.
• Experience gathering and documenting business, functional, data, and integration requirements.
• Experience supporting regulated business functions within pharmaceutical, biotechnology, clinical research, or a related life-sciences environment.
• Familiarity with clinical, regulatory, or medical-writing content and associated document workflows.
• Experience collaborating directly with technical developers and solution or enterprise architects.
• Understanding of integrations between enterprise applications, including requirements related to data exchange, metadata, workflows, and system dependencies.
• Ability to convert business needs into detailed user stories, acceptance criteria, use cases, process flows, and functional specifications.
• Experience supporting Agile development teams and participating in backlog refinement, sprint planning, solution reviews, and testing activities.
• Strong workshop facilitation, stakeholder management, and written communication skills.
• Ability to manage ambiguity, organize complex requirements, and drive decisions among multiple stakeholder groups.
• Ability to work effectively with internal teams, external vendors, and multiple consulting partners.

Preferred Qualifications

• Hands-on experience with Veeva RIM, Veeva Vault RIM, or comparable regulatory information management platforms.
• Previous experience supporting …