Please Accept our Privacy Policy
Position Summary
The REMS Business Analyst serves as the critical liaison betweenbusinessstakeholders,sponsors,and 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 inREMS,pharmaceutical, healthcare,orlife 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.
Powered by JazzHR
AO4CD2lTjR