Medical Legal and Regulatory Coordinator

🕒 June 30

🌪️ Kansas – Remote

🌪️ Kansas – Remote

⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

🧑‍💼 Attorney / Lawyer

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EVERSANA

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

💼 Consulting

🏥 Healthcare

⚕️ Healthcare Insurance

Consulting • Healthcare • Healthcare Insurance

EVERSANA is a comprehensive service provider focused on integrated commercial solutions for the life sciences industry. The company offers a wide range of services including advisory and management consulting, regulatory consulting, patient services, market access strategies, pricing and revenue management, medical affairs, and digital transformation. EVERSANA is known for its expertise in drug commercialization, enabling companies to effectively launch and manage pharmaceutical products. With a platform powered by data and analytics, EVERSANA addresses challenges related to drug pricing, market access, patient adherence, and product delivery, helping companies optimize their commercial strategies and enhance patient outcomes. The company emphasizes innovation and has been recognized for its use of AI and data analytics within the life sciences sector.

📋 Description

• Manages the end-to-end MLR process. • Responsible for scheduling, setting the agenda, and leading Review Committee meetings. • Add live discussion notes for comments discussed in Veeva Vault Scribe meeting minutes, circulate draft meeting minutes for Committee approval and finalize and file approved minutes • Ensure all covered communications are properly vetted through the review process utilizing the online review system (e.g., Veeva Vault PromoMats and Vault MedComms) • Cascade and enforce any new policies and guidelines related to review of materials. • Verifies that materials are assigned to the appropriate review path. • Rejects incomplete submissions and materials that are not review ready. • Facilitates/documents discussion in live meetings. • QCs Final Document vs. Approved Document • Supports FDA 2253 submissions, or country specific regulatory submissions with MLR Regulatory Reviewer/Partner • Support the development of project plans • Support medical content development team • Support upload of materials into clients’ review and approval platforms, including supporting annotating, anchoring references, etc. • Support Medical Affairs and Medical Information leadership in developing and managing project plans for key initiatives

🎯 Requirements

• Graduates in any Life Sciences / Biomedical field. • At least 2 years of experience in a healthcare agency or pharmaceutical company • Experience with use of Veeva Vault PromoMats / MedComms • Experience in Scientific Writing / Scientific Reviewing / MLR Project management • Time management • Meeting management • Excellent customer service skills. • Computer proficiency in Outlook and Microsoft Office Suite (Word, Excel, PowerPoint, and other Window applications).

🏖️ Benefits

• Medical, Legal and Regulatory (MLR) Coordinator Contract • flexible work arrangements • reasonable accommodation for employees with disabilities