Business Analyst, Risk Evaluation & Mitigation Strategies (REMS)

Position Summary

The REMS Business Analyst serves as the critical liaison betweenbusinessstakeholderssponsorsand IT teams to ensure the successful delivery of Risk Evaluation and Mitigation Strategy (REMS) programs and supportingREMSsolutions. This roleis responsible forgathering analyzing and translating client requirements into detailed business and functional requirements while coordinating cross-functional projects to ensure compliant REMS websites and technology solutions are delivered on time andin accordance withregulatory requirements.

Key Responsibilities

Business Analysis & Requirements Management

• Partner with clients and internal stakeholders to gather document andvalidatebusiness requirements for REMS programs and related technology solutions.

• Analyze client needs and translate them into clear actionablebusiness requirementsfor IT development teams.

• Develop andmaintainrequirement documents user stories process flows use cases and functional specifications.

• Facilitaterequirementsreview sessions and obtain approval for project deliverables.

• Identifygaps risks and opportunities for process improvement within REMS-related systems and workflows.

Project Coordination & Delivery

• Coordinate multiple concurrent projects and initiatives involving IT compliance operations and business stakeholders.

• Collaborate with project managers developers quality assurance teams and business owners to ensure project milestones and deliverables are met.

• Track project risks issues and dependencies escalating concerns asappropriate.

• Support user acceptance testing (UAT) activities and ensure solutions meet business and compliance requirements prior to deployment.

Compliance & Website Implementation

• Partner with IT teams to deliver REMS websites and technology solutions that meet regulatory client and organizational requirements.

• Ensure implemented solutions align with compliance standards businessobjectives and established quality expectations.

• Participate in validation and change management processes to support compliant system implementations.

• Monitorsystem enhancements and website updates for regulatory and business impacts.

Stakeholder & Cross-Functional Collaboration

• Serve as the primary point of contact between business teams IT compliance and operational stakeholders.

• Build strong working relationships across internal departments tofacilitateeffective communication and project execution.

• Lead meetings andrequirement gatheringsessions with diverse stakeholder groups.

• Communicate project status requirementchanges andimplementation ofupdates to stakeholders at all levels.

Qualifications

Required

• Experience gathering and documenting business requirements and translating them into technical requirements.

• Strong project coordination and organizational skills with the ability to manage multiple priorities simultaneously.

• Excellent verbal and written communication skills.

• Ability to effectively interact with clients IT teams and cross-functional business partners.

• Strong analytical problem-solving andcritical-thinkingskills.

Preferred

• Experience working inREMSpharmaceutical healthcareorlife sciencesenvironments.

• Knowledge of software development lifecycle (SDLC) methodologies.

• Familiarity with website implementation projects.

• Knowledge of regulatory and compliance requirements within the healthcare or pharmaceutical industry.

Key Competencies

• Requirements Gathering & Analysis

• Business Process Mapping

• Project Coordination

• Cross-Functional Collaboration

• Risk Identification & Mitigation

• Regulatory Compliance Awareness

• Communication & Presentation Skills

• Problem Solving

This role is ideal for a professional who can bridge the gap between business needs and technical execution while ensuring REMS technology solutions are delivered efficiently compliantly and successfully.