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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # REMS Operations & Implementation Lead - **Company:** MMS Inc. - **Location:** Raleigh, NC, United States (Remote available) - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Agile Methodology, Clinical Data Repository, Software Documentation, Multimedia Messaging Services, Systems Development Life Cycle, Requirements Management, Software Engineering, Information Technology - **Published:** September 23, 2026 - **Apply:** https://www.careerbuilder.com/job-details/rems-operations-implementation-lead-remote-us-raleigh-nc--438ecfed-8f54-48ce-b92e-73d3be4191af ## About the Role Applicants must be legally authorized to work in the U.S. for any employer; we cannot sponsor visas (e.g., H-1B) or offer work authorization transfers at this time., 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, and critical-thinking skills. Preferred * 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 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., Acceptance Testing, Accreditation Standards, Agile Programming Methodologies, Biology, Biotech and Pharmaceutical, Business Analysis, Business Processes, Change Management, Clinical Data, Clinical Research, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Customer Relations, Customer Satisfaction, Customer/Client Research, Employee Retention, Environmental Sciences, Healthcare, IT Requirements, LinkedIn, Medical Equipment, Multitasking, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Process Flow, Process Improvement, Project Execution, Project Tracking, Project/Program Coordination, Quality Assurance, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Requirements Management, Requirements Validation/Verification, Risk Analysis, Risk Management, Software Development Lifecycle (SDLC), Team Player, Technical Delivery, Time Management, Use Cases, User Documentation, Website Management, Wireless Multimedia Messaging Service, Writing Skills ## Description The REMS Business Analyst serves as the critical liaison between business stakeholders, sponsors, and IT teams to ensure the successful delivery of Risk Evaluation and Mitigation Strategy (REMS) programs and supporting REMS solutions. This role is responsible for gathering, 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, and in accordance with regulatory requirements., Business Analysis & Requirements Management * 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. 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 as appropriate. * 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, 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. 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 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. ## Related Videos - [Humanizing Your Documentation](https://www.wearedevelopers.com/videos/476-humanizing-your-documentation) - [The Avengers Initiative (Practical Ethics for Software Engineers)](https://www.wearedevelopers.com/videos/2070-the-avengers-initiative-practical-ethics-for-software-engineers) - [ShapeShift: Reinventing Agile for a B2B SaaS Scale-Up](https://www.wearedevelopers.com/videos/1655-shapeshift-reinventing-agile-for-a-b2b-saas-scale-up) - [SRE Methods In an Agency Environment](https://www.wearedevelopers.com/videos/348-sre-methods-in-an-agency-environment) - [Security Pitfalls for Software Engineers](https://www.wearedevelopers.com/videos/726-security-pitfalls-for-software-engineers) - [Why Is Software Documentation Still Static – And Why Modern Browsers Deserve Better](https://www.wearedevelopers.com/videos/2054-why-is-software-documentation-still-static-and-why-modern-browsers-deserve-better) ## Related Articles - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [Mastering Remote Work: Tips for Developers](https://www.wearedevelopers.com/magazine/558-mastering-remote-work-tips-for-developers) - [Best Job Boards for Remote Work for Developers](https://www.wearedevelopers.com/magazine/290-best-job-boards-for-remote-work-for-developers) - [Best Paying Remote Jobs](https://www.wearedevelopers.com/magazine/255-best-paying-remote-jobs) - [Remote Work: Best Practices for Developers](https://www.wearedevelopers.com/magazine/315-remote-work-best-practices-for-developers) - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers)