REMS Operations & Implementation Lead

The REMS Operations & Implementation Lead position is based in the United States and involves bridging business needs with technology solutions in the life sciences sector. Key responsibilities include:

• Partnering with clients, sponsors, and internal stakeholders to gather, analyze, document, and validate business requirements.
• 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.
• Maintain 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.

Requirements include:

• 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.

Legal requirements: Candidates must be legally authorized to work in the United States for any employer without current or future visa sponsorship or work authorization transfer.