Regulatory Affairs Coordinator

Company Description At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us! Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA. Job Description 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 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: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: 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 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. Note: a disability accommodation policy statement has been included in the original description; for the refined version, references to ADA accommodation language are kept as plain text where appropriate. 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. 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 Qualifications MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. 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 Excellent customer service skills. Technology/Equipment :Computer proficiency in Outlook and Microsoft Office Suite (Word, Excel, PowerPoint, and other Window 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 the 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 her/his 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: The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position. 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. #J-18808-Ljbffr