Praxis Precision Medicines

remotive

CMLR Coordinator @ Praxis Precision Medicines

USARemoteFull-timePosted 1 days ago

Opens on remotive

About this role

Role Description

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

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.

Qualifications

Bachelor’s degree preferred or equivalent relevant experience 3+ years of experience supporting MLR, promotional review, regulatory operations, commercial operations, or related functions within pharmaceutical, biotech, or healthcare environments Familiarity with MLR review systems and workflow platforms such as Veeva PromoMats or similar tools Strong project management and organizational skills with exceptional attention to detail Ability to manage multiple projects and deadlines simultaneously in fast-paced environments Strong written and verbal communication skills with confidence interacting across functions and levels High degree of professionalism, discretion, and accountability Demonstrated ability to identify operational inefficiencies and drive practical solutions Comfortable working in ambiguity and adapting quickly as priorities evolve Embodies a collaborative, ownership-driven mindset aligned with Praxis’s values of Trust, Curiosity, Ownership, and Results

Requirements

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

Benefits

99% of the premium paid for medical, dental and vision plans Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize coverage Dollar-for-dollar match up to 6% on eligible 401(k) contributions Long-term stock incentives and ESPP Discretionary quarterly bonus Flexible wellness benefit Generous PTO, paid holidays, and company-wide shutdowns Join a phenomenal crew of colleagues who are smart, engaged, and inspiring

Company Description

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.

Core Values: Trust, Ownership, Curiosity, and Results

Skills

mlr operationsregulatory compliancecross-functional collaborationattention to detail

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