CMLR Coordinator

Praxis Precision Medicines, Inc.Remote · Posted 24 days ago

Full-timeRemoteEst. 110,000 USD

Description

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

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.

Annualized Base Salary

$100,000—$120,000 USD

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together!

Company Overview

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

Attention: Job Scam Alert
Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com.

Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

CMLR Coordinator

Description

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