Medical, Legal and Regulatory (MLR) Coordinator
EVERSANA
Summary
The Medical, Legal and Regulatory (MLR) review is an essential process in healthcare marketing to make sure advertising, promotional and non-promotional content is accurate, compliant, and ready to be published. The MLR process must rigorously control and execute review, approval and document filing actions. As part of the MLR team, the Medical, Legal and Regulatory (MLR) Coordinator is responsible for managing all the MLR processes for a dedicated client. The Medical, Legal and Regulatory (MLR) Coordinator ensures that all administrative and program management support for the client’s MLR process operates effectively and in full compliance with all internal and external policies and regulations.
Job description
Essential Duties and Responsibilities
- 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
Medical Content Support Responsibilities
- 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.
Medical Affairs and Medical Information Project Management Support
- Support Medical Affairs and Medical Information leadership in developing and managing project plans for key initiatives
- Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.
- All other duties as assigned.
Expectations of the Job
- Travel: In general, this position does not travel.
- Hours: Able to work full-time and be flexible with work scheduling as required by clients and management.
- Metrics: Maintain and contribute toward process improvement which positively impacts metrics associated with activities of the MLR Review process; metrics are subject to change annually or more often as deemed necessary.
- Customer Services: Maintain and improve customer services associated with the activity of the MLR review.
- Time Management: Complete MLR coordination responsibilities in a timely manner.
Requirements
- Graduates in any Life Sciences / Biomedical field.
- Must demonstrate excellent ability to communicate effectively in English, both orally and in writing.
- 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).
Company overview
EVERSANA is a leading independent provider of global services to the life sciences industry, founded in 2014 and headquartered in Milwaukee, Wisconsin. The company specializes in comprehensive commercialization solutions that span the entire product lifecycle, from clinical development through market launch and beyond. EVERSANA's integrated services include regulatory consulting, market access strategies, global pricing, patient analytics, revenue management, and distribution logistics. The company serves over 650 organizations worldwide, including innovative startups and established pharmaceutical companies, supporting more than 160 brands across 80+ countries. With its EVERSANA COMPLETE Commercialization model, the company provides end-to-end outsourcing solutions that help life sciences companies navigate complex global markets, optimize therapy launches, and deliver sustainable value to patients, prescribers, and payers. EVERSANA operates as an extension of client teams, offering expertise in therapeutic areas including oncology, cardiology, neurology, rare diseases, and women's health.