Medical Legal & Regulatory Coordinator

🕒 July 2

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Cristcot

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2008

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

💰 $10.5M Venture Round - Cristcot on 2025-06

Healthcare • Manufacturing • Pharmaceuticals

Cristcot is a pharmaceutical development and research company specializing in innovative drug formulations and unobtrusive drug-device combination technologies designed to improve patient adherence, reduce treatment burden, and integrate therapies into daily life. Founded in 2008 and headquartered in Austin, Texas, Cristcot provides clinical research design and execution, novel formulation and delivery engineering, specialized assay development, and regulatory strategy support; its lead investigational therapy has completed a pivotal Phase 3 study. The company focuses on solving overlooked barriers in disease management by creating intuitive, cost-effective solutions that enable more effective and confident care.

📋 Description

•Oversee and manage MLR review and approval submissions for Marketing, Medical Affairs, and Corporate Communications materials. •Partner with Medical Affairs teams to ensure appropriate submission ownership and coordination of review materials. •Coordinate MLR review meetings and ensure timely routing of materials to designated reviewers. •Maintain and manage the Master MLR Review Schedule across all business functions. •Develop, maintain, and communicate a weekly MLR 'Hot Sheet' highlighting all active and upcoming review activities requiring approval. •Track review status, approvals, reviewer comments, revision cycles, and final disposition of materials. •Collaborate with agencies, content creators, and internal library resources to ensure supporting references, journal articles, and documentation are appropriately maintained within Zotero and related content repositories. •Partner with leadership to identify workflow efficiencies and recommend process improvements to enhance review timelines and stakeholder experience. •Ensure proper version control and archival of approved materials and supporting documentation. •Maintain audit-ready records for all promotional review activities and approvals. •Manage tracking systems for FDA submissions, OPDP correspondence, advisory comments, approval records, version histories and compliance documentation •Generate and distribute MLR metrics, dashboards, and reporting to support business and compliance objectives. •Conduct training sessions for internal teams, external agencies, and business partners on promotional compliance requirements and MLR best practices.

🎯 Requirements

•Bachelor’s degree in Life Sciences, Business, Marketing, Communications, Healthcare Administration, or a related field. •3–7+ years of experience supporting MLR/PRC operations, promotional review, regulatory operations, compliance, or pharmaceutical marketing processes. •Working knowledge of FDA promotional regulations, OPDP requirements, and pharmaceutical industry compliance standards. •Experience with promotional review systems such as Veeva PromoMats, Vodori, or similar platforms. •Strong project management, organizational, and coordination skills. •Excellent attention to detail and documentation management capabilities. •Ability to manage multiple projects simultaneously in a fast-paced environment. •Strong communication, collaboration, and stakeholder management skills. •Experience supporting Medical Affairs, Commercial, and Corporate Communications review processes preferred. •Knowledge of content management systems, reference libraries, and citation management tools such as Zotero preferred. •Experience developing compliance metrics, dashboards, and reporting preferred. •Familiarity with audit readiness and inspection support activities preferred. •Project management certification or formal process improvement training is a plus. •Ability to support meetings across multiple U.S. time zones. •May require occasional travel for team meetings, launch activities, or training.

🏖️ Benefits

•Flexible working hours