Business Analyst, Risk Evaluation & Mitigation Strategies (REMS) - Remote

MMS is an award-winning, data-focused clinical research organization supporting the pharmaceutical, biotech, and medical device industries with complex trial data and regulatory submission challenges. The REMS Business Analyst serves as a liaison between stakeholders, sponsors, and IT teams, gathering and translating requirements, coordinating cross-functional projects, and ensuring compliant REMS websites and technology solutions are delivered successfully.

Responsibilities:

• Partner with clients and internal stakeholders to gather, document, and validate business requirements for REMS programs and related technology solutions
• Analyze client needs and translate them into clear, actionable business requirements for IT development teams
• Develop and maintain requirement documents, user stories, process flows, use cases, and functional specifications
• Facilitate requirements review sessions and obtain approval for project deliverables
• Identify gaps, risks, and opportunities for process improvement within REMS-related systems and workflows
• 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 as appropriate
• Support user acceptance testing (UAT) activities and ensure solutions meet business and compliance requirements prior to deployment
• 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, business objectives, and established quality expectations
• Participate in validation and change management processes to support compliant system implementations
• Monitor system enhancements and website updates for regulatory and business impacts
• Serve as the primary point of contact between business teams, IT, compliance, and operational stakeholders
• Build strong working relationships across internal departments to facilitate effective communication and project execution
• Lead meetings and requirement gathering sessions with diverse stakeholder groups
• Communicate project status, requirement changes, and implementation of updates to stakeholders at all levels

Requirements:

• 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, and critical-thinking skills
• Experience working in REMS, pharmaceutical, healthcare, or life sciences environments
• Knowledge of software development lifecycle (SDLC) methodologies
• Familiarity with website implementation projects
• Knowledge of regulatory and compliance requirements within the healthcare or pharmaceutical industry