REMS Operations & Implementation Lead in New York at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a REMS Operations & Implementation Lead based in the United States.

This role sits at the intersection of business analysis, technology delivery, and regulatory compliance within the life sciences sector.
You’ll serve as a key bridge between clients, sponsors, IT teams, compliance specialists, and operational stakeholders.
The position focuses on translating complex business needs into clear requirements that enable compliant and effective REMS solutions.
You’ll coordinate multiple initiatives, helping ensure technology implementations and REMS websites are delivered accurately and on schedule.
Your work will directly support regulatory programs designed to manage medication risks and protect patients.
The environment is collaborative and cross-functional, with significant exposure to clients and diverse technical and business teams.
This is an opportunity for a detail-oriented professional to make a meaningful impact on regulated healthcare technology and program delivery.

• Partner with clients, sponsors, and internal stakeholders to gather, analyze, document, and validate business requirements for REMS programs and supporting technology solutions.
• Translate business needs into clear and actionable technical and functional requirements for IT and development teams.
• Create and maintain requirement documentation, user stories, process flows, use cases, and functional specifications.
• Facilitate requirements workshops and review sessions, ensuring stakeholder alignment and securing approval for key project deliverables.
• Identify requirements gaps, project risks, dependencies, and opportunities to improve REMS-related processes, systems, and workflows.
• Coordinate multiple concurrent projects involving IT, compliance, operations, business stakeholders, project managers, developers, and quality assurance teams.
• Track project milestones, risks, issues, and dependencies while escalating concerns and supporting timely resolution.
• Support user acceptance testing (UAT) and help verify that implemented solutions meet business, regulatory, quality, and compliance requirements before deployment.
• Collaborate with IT teams on the implementation and enhancement of REMS websites and technology solutions.
• Participate in system validation, change management, and implementation activities to support compliant technology delivery.
• Monitor website updates, system enhancements, and process changes for potential regulatory or business impacts.
• Act as a central point of contact between business, IT, compliance, and operational teams, ensuring effective communication throughout project lifecycles.
• Lead stakeholder meetings, requirements sessions, and project discussions, communicating status, changes, decisions, and implementation updates to audiences at different levels.

• Demonstrated experience gathering, analyzing, documenting, and translating business requirements into detailed technical or functional requirements.
• Strong project coordination, organization, and prioritization skills, with the ability to manage multiple initiatives and competing deadlines.
• Excellent written and verbal communication skills, with confidence working across client, technical, compliance, and business stakeholder groups.
• Strong analytical, critical-thinking, and problem-solving capabilities, with the ability to identify gaps, assess risks, and develop practical solutions.
• Demonstrated ability to bridge business needs and technical execution while maintaining focus on quality, compliance, and delivery outcomes.
• Experience working collaboratively with IT, development, quality assurance, project management, and business teams.
• Experience in REMS, pharmaceutical, biotechnology, healthcare, clinical research, or life sciences environments is strongly preferred.
• Familiarity with software development lifecycle (SDLC) methodologies and technology implementation processes is desirable.
• Experience with website implementation projects is a plus.
• Knowledge of healthcare or pharmaceutical regulatory and compliance requirements is preferred.
• Strong competencies in requirements gathering, business process mapping, project coordination, cross-functional collaboration, risk identification and mitigation, and stakeholder communication.
• Ability to work independently, maintain attention to detail, and operate effectively in a regulated, fast-moving environment.
• Candidates must be legally authorized to work in the United States for any employer without current or future visa sponsorship or work authorization transfer.

• Full-time, remote position available to candidates across multiple U.S. states.
• Opportunity to work within an award-winning, data-focused clinical research environment.
• Collaborative and inclusive workplace focused on professional growth and meaningful contributions to clinical research.
• Exposure to pharmaceutical, biotechnology, medical device, regulatory, and clinical technology initiatives.
• Opportunity to work on complex REMS programs and technology solutions with direct impact on regulatory compliance and patient safety.
• Cross-functional collaboration with clients, sponsors, technology teams, compliance professionals, and operational leaders.
• The original posting does not specify a salary range or detailed benefits package; compensation and applicable benefits should be confirmed during the hiring process.
• U.S. work authorization is required, and visa sponsorship is not available for this position.