REMS Operations & Implementation Lead (Remote - US)

About the role

The REMS Business Analyst plays a crucial role in ensuring the successful delivery of Risk Evaluation and Mitigation Strategy (REMS) programs and their associated technology solutions. This position requires a deep understanding of both business and technical requirements, as well as strong project coordination and stakeholder management skills.

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.

Qualifications

• 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.

Preferred Qualifications

• 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.

Key Competencies

• Requirements Gathering & Analysis
• Business Process Mapping
• Project Coordination
• Cross-Functional Collaboration
• Risk Identification & Mitigation
• Regulatory Compliance Awareness
• Communication & Presentation Skills
• Problem Solving