Medical, Legal and Regulatory; MLR Coordinator

Position Overview

The Medical, Legal and Regulatory (MLR) Coordinator is responsible for managing all MLR processes for a dedicated client. The role ensures that administrative and program management support operates effectively and complies with all internal and external policies and regulations, including accurate, compliant advertising, promotional and non‑promotional content.

• Manage the end‑to‑end MLR process.
• Schedule, set agendas and lead Review Committee meetings; add live discussion notes for comments in Veeva Vault.
• Scribe meeting minutes, circulate draft minutes for Committee approval, finalize and file approved minutes.
• Ensure all communications are properly vetted through the review process using systems such as Veeva Vault Promo Mats and Vault Med Comms.
• Enforce new policies and guidelines related to material review.
• Verify that materials are assigned to the appropriate review path, reject incomplete submissions, and document discussion in live meetings.
• Perform QC of final versus approved documents.
• Support FDA 2253 submissions or country‑specific regulatory submissions in partnership with MLR Regulatory Reviewer/Partner.
• Support development of project plans and medical content development team.
• Support upload of materials into client review and approval platforms, including annotating and anchoring references.
• Assist Medical Affairs and Medical Information leadership in developing and managing project plans for key initiatives.
• Model inclusive behaviors and proactively manage bias.
• Complete all duties as assigned.

• 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 metrics associated with the MLR Review process.
• Customer Services
  :
  Maintain and improve customer services associated with MLR review activities.
• Time Management
  :
  Complete MLR coordination responsibilities in a timely manner.

• Education
  :
  Graduate of a Life Sciences or Biomedical field.
• Excellent oral and written communication skills in English.
• At least 2 years of experience in a healthcare agency or pharmaceutical company.
• Experience with Veeva Vault Promo Mats / Med Comms.
• Experience in Scientific Writing, Scientific Reviewing or MLR.
• Project management, time management, and meeting management skills.
• Excellent customer service skills.
• Computer proficiency in Outlook and Microsoft Office Suite (Word, Excel, PowerPoint and other Windows applications).

• Education
  :
  Graduate or postgraduate in Pharmacy or Medicine.
• Working knowledge of global healthcare compliance statutes and laws.
• Ability to perform assignments independently, requiring extensive experience, skill, and knowledge.
• Advanced computer skills including presentation, word processing, and spreadsheet software.
• Proven ability to manage multiple tasks, set priorities and meet deadlines.
• Experience managing cross‑functional projects.
• Familiarity with U.S. drug/device advertising and promotion laws and industry best practices.
• Knowledge of medical terminology (preferred but not required).
• Quality‑oriented with consistent attention to detail.
• Ability to follow established processes and adapt to new practices and priorities as required.
• Positive attitude and energy; strong communication and interpersonal skills; innovative problem‑solving; high moral and ethical standards.

Office work requires frequent reaching, grasping, standing and/or sitting for long periods (up to 90% of the shift). Requires walking, talking and hearing; occasional lifting of up to 25 pounds. Work environment is moderately quiet with frequent interruptions and multiple demands.

Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, EVERSANA provides reasonable accommodation when requested by a qualified applicant with a disability unless such accommodation would cause an undue hardship.