REMS Operations & Implementation Lead

📋 Description

• Bridge between clients, sponsors, IT, compliance, and operations to deliver REMS solutions.
• Translate business needs into technical/functional requirements for IT and dev teams.
• Coordinate multiple concurrent REMS projects across stakeholders.
• Support user acceptance testing and ensure solutions meet regulatory requirements.
• Lead requirements workshops and maintain documentation and process flows.
• Monitor changes for regulatory or business impacts in REMS programs.

🎯 Requirements

• Experience gathering, analyzing, and translating business requirements into technical specs.
• Strong project coordination, organization, and prioritization skills.
• Excellent communication across client, technical, compliance, and business teams.
• Analytical, problem-solving, and risk mitigation capabilities.
• Experience in REMS/pharma/biotech/healthcare/life sciences preferred.
• Familiarity with SDLC and software implementation processes; website projects a plus.

🎁 Benefits

• Full-time, remote position across multiple U.S. states.
• Work in a data-focused clinical research environment.
• Collaborative, inclusive workplace with growth opportunities.
• Exposure to pharma/biotech/regulatory tech initiatives.
• Impact REMS programs and regulatory compliance with patient safety focus.
• Cross-functional collaboration with clients, sponsors, and teams.