Medical, Legal and Regulatory (MLR) Coordinator

Medical, Legal and Regulatory (MLR) Coordinator

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.

Essential duties and responsibilities include managing the end-to-end MLR process, scheduling, setting the agenda, and leading Review Committee meetings, adding live discussion notes for comments discussed in Veeva Vault, scribing meeting minutes, circulating draft meeting minutes for Committee approval and finalizing and filing approved minutes, ensuring all covered communications are properly vetted through the review process utilizing the online review system, cascading and enforcing any new policies and guidelines related to review of materials, verifying that materials are assigned to the appropriate review path, rejecting incomplete submissions and materials that are not review ready, facilitating/documenting discussion in live meetings, QCing final document vs. approved document, and supporting FDA 2253 submissions, or country specific regulatory submissions with MLR Regulatory Reviewer/Partner.

Medical content support responsibilities include supporting the development of project plans, supporting medical content development team, supporting upload of materials into clients' review and approval platforms, including supporting annotating, anchoring references, etc.

Medical affairs and medical information project management support includes supporting Medical Affairs and Medical Information leadership in developing and managing project plans for key initiatives, demonstrating a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias, and all other duties as assigned.

Expectations of the job include travel, hours, metrics, customer services, and time management.

Minimum knowledge, skills and abilities include graduates in any Life Sciences / Biomedical field, 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, and computer proficiency in Outlook and Microsoft Office Suite (Word, Excel, PowerPoint, and other Window applications).

Preferred qualifications include graduates/postgraduates in Pharmacy or Medicine, working knowledge of or familiarity with global healthcare compliance statutes and laws, ability to perform assignments with a high degree of independence requiring extensive experience, skill, and knowledge, excellent computer skills including competency in presentation, word processing and spreadsheet software, utilizing MS Office Suite, proven ability to manage multiple tasks, set priorities and meet deadlines, ability to manage cross-functional projects, familiar with laws and regulations regarding US drug / device advertising and promotion, including industry best practices, knowledge of medical terminology, quality-oriented and demonstrate consistent attention to detail, ability to follow established processes and procedures and the flexibility to adopt new practices and priorities as required, positive attitude and energy, communication skills, innovator, and highly principled.

Physical/mental demands and working environment include office, while performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands.