CMLR Coordinator

The Opportunity

Praxis is seeking a highly organized, detail-oriented, and proactive CMLR Coordinator to drive efficient, compliant review and approval processes for promotional and medical materials across the organization. This role sits at the center of cross-functional collaboration, partnering closely with Commercial, Medical Affairs, Regulatory, Legal, Compliance, and external agencies to ensure materials move quickly, accurately, and responsibly through the Medical, Legal, and Regulatory (MLR) review process.

This role is critical to enabling speed without sacrificing quality or compliance. The right person thrives in fast-moving environments, communicates clearly, anticipates obstacles before they become problems, and brings a strong ownership mindset to operational execution. You are not simply managing workflows — you are helping teams operate more effectively and ensuring patients, providers, and stakeholders receive accurate and compliant information.

This is an excellent opportunity for someone who enjoys building structure, improving processes, and working cross-functionally in a mission-driven biotech environment. The ideal candidate combines deep knowledge of MLR operations with strong business judgment, systems thinking, and the ability to influence across functions without direct authority.

Primary Responsibilities

• Coordinate end-to-end MLR review workflows for promotional, educational, and corporate materials across multiple functions and stakeholders
• Manage review timelines, approvals, version control, documentation, and routing within MLR systems and platforms
• Partner with Commercial, Medical, Regulatory, Legal, and Compliance teams to ensure timely and compliant review processes
• Facilitate MLR meetings, capture feedback, track action items, and drive alignment toward final approvals
• Identify workflow bottlenecks and recommend process improvements that increase efficiency, transparency, and accountability
• Ensure accurate maintenance of review records, archives, and audit-ready documentation in accordance with company policies and regulatory requirements
• Support training and onboarding for internal stakeholders and agency partners on MLR processes, systems, and best practices
• Serve as a reliable operational partner who proactively communicates risks, status updates, and timeline changes

Qualifications and Key Success Factors

• Coordinate end-to-end MLR review workflows for promotional, educational, and corporate materials across multiple functions and stakeholders
• Manage review timelines, approvals, version control, documentation, and routing within MLR systems and platforms
• Partner with Commercial, Medical, Regulatory, Legal, and Compliance teams to ensure timely and compliant review processes
• Facilitate MLR meetings, capture feedback, track action items, and drive alignment toward final approvals
• Identify workflow bottlenecks and recommend process improvements that increase efficiency, transparency, and accountability
• Ensure accurate maintenance of review records, archives, and audit-ready documentation in accordance with company policies and regulatory requirements
• Support training and onboarding for internal stakeholders and agency partners on MLR processes, systems, and best practices
• Serve as a reliable operational partner who proactively communicates risks, status updates, and timeline changes

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.