About this role
About the Role The MLR Coordinator manages end-to-end Medical, Legal and Regulatory review for a dedicated client, ensuring promotional and non-promotional content is accurate and compliant with internal policies and external regulations. This role provides administrative and program-management support across the MLR process and collaborates with medical, regulatory, and content teams. What You'll Do
- Manages the end-to-end MLR process for a dedicated client.
- Responsible for scheduling, setting the agenda, and leading Review Committee meetings.
- Records live discussion notes for comments discussed in Veeva Vault Scribe meeting minutes; circulates draft minutes for Committee approval and finalizes and files approved minutes.
- Ensures all communications are properly vetted through the review process using online systems (Veeva Vault PromoMats and Vault MedComms).
- Cascades and enforces new policies and guidelines related to review of materials.
- Verifies materials are assigned to the appropriate review path; rejects incomplete submissions and materials not review-ready; facilitates and documents discussion in live meetings.
- Performs QC of Final Document vs. Approved Document.
- Supports FDA 2253 submissions, or country-specific regulatory submissions with MLR Regulatory Reviewer/Partner.
- Medical Content Support: supports development of project plans; supports medical content development; assists uploading materials to client review/approval platforms, including annotating and anchoring references.
- Medical Affairs and Medical Information Project Management Support: assists leadership in developing and managing project plans for key initiatives.
- Demonstrates commitment to diversity, equity and inclusion by modeling inclusive behaviors and managing bias.
- All other duties as assigned.
- ADA accommodation: EVERSANA provides reasonable accommodation per the Americans with Disabilities Act (ADA) and applicable laws upon request. What We're Looking For
- Education: 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 Veeva Vault PromoMats / MedComms.
- Experience in Scientific Writing / Scientific Reviewing / MLR.
- Project management, time management, and meeting management.
- Excellent customer service skills.
- Technology: Proficiency in Outlook and Microsoft Office Suite (Word, Excel, PowerPoint, and other Windows applications). Nice to Have
- Education: Graduates/Postgraduates in Pharmacy or Medicine preferred.