Regulatory Affairs Coordinator

Medical, Legal and Regulatory (MLR) Coordinator Contract Department: Clinical & Medical Job Family: Medical Writing THE POSITION 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 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. MEDICAL, LEGAL AND REGULATORY (MLR) COORDINATOR 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 minutes for Committee approval and finalize & file approved minutes. Ensure all covered communications are properly vetted through the review process utilizing the online review systems (e.g., Veeva Vault PromoMats and Vault MedComms). Cascade and enforce new policies and guidelines related to the review of materials. Verify that materials are assigned to the appropriate review path. Reject incomplete submissions and materials that are not review ready. Facilitate/document discussion in live meetings. QC final document vs. approved document. Support FDA 2253 submissions, or country‑specific regulatory submissions with MLR Regulatory Reviewer/Partner. MEDICAL CONTENT SUPPORT RESPONSIBILITIES Support the development of project plans. Support upload of materials into client review and approval platforms, including annotating and anchoring references. 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 MLR review activities; 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. The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position. An individual in this position must be able to successfully perform the expectations listed above. MINIMUM KNOWLEDGE, SKILLS AND ABILITIES Education : Graduates in any Life Sciences / Biomedical field. Must demonstrate excellent ability to communicate effectively in English, both orally and in writing. Experience and/or Training : 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. Technology/Equipment : Computer proficiency in Outlook and Microsoft Office Suite (Word, Excel, PowerPoint, and other Windows applications). PREFERRED QUALIFICATIONS Education : Graduates/Postgraduates in Pharmacy or Medicine preferred. Experience and/or Training : 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 (preferred but not required). Must be quality‑oriented and demonstrate consistent attention to detail. Must have the ability to follow established processes and procedures and flexibility to adopt new practices and priorities as required. Positive Attitude and Energy – exhibits an upbeat attitude, a genuine interest in others and a sense of humor. Energizes others and heightens morale through attitude. Communication Skills – possesses the ability to develop and articulate ideas and information that generate understanding and create a climate that motivates and encourages others to participate. Innovator – transforms creative ideas into original solutions that positively impact the company’s performance. Highly Principled – proves to be a professional of unquestionable integrity, credibility and character who demonstrates high moral and ethical behavior. PHYSICAL/MENTAL DEMANDS AND WORKING ENVIRONMENT 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. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by an employee with a disability, unless such accommodation would cause an undue hardship for EVERSANA. If reasonable accommodation is needed to perform the essential functions of your job position, please contact Human Resources. BENEFITS AND COMPENSATION EVERSANA is committed to providing competitive salaries and benefits for all employees. Compensation will be determined based on relevant experience, other job‑related qualifications/skills, and geographic location. More information about EVERSANA’s benefits package can be found at eversana.com/careers. EEO STATEMENT EVERSANA is an Equal Opportunity Employer. Diversity, equity & inclusion are key to our success. All personnel have rights under federal, state, and local laws. #J-18808-Ljbffr