We are seeking a Manager, Medical Review Committee to join our team. Working with the Medical Review Committee staff, the MRC Manager will drive and coordinate the activities of the MRC in the US and at times, internationally as needed, ensuring the production of high quality, compliant materials in a timely and efficient manner. Specifically this person will be responsible for tracking projects from inception through production, maintaining appropriate systems and documentation files, and coordinating any associated regulatory submissions. Additionally this individual, working with the MRC Global Manager, will be tasked with maintaining and enforcing associated operating procedures, managing high-level committee meetings, ensuring continued compliance with all laws, policies and procedures, and providing guidance to material sponsors on submission of high-quality and compliant work.

As a Manager, Medical Review Committee member, a typical day may include the following:

• Lead the Medical Affairs Review Committee (MRC) process for assigned Regeneron assets and act as the business process owner for US MRC
• Lead projects related to MRC process and associated system and facilitate delivery materials to the MRC

Working with the Global MRC Manager:

• Coordinate initial and ongoing training for MRC process and system and manage user access and assigned training, including changes, updates and upgrades to the system in collaboration with the system owner and system owner committee
• Manage license requests and license numbers
• Assists with updates and distribution of guidance documents for MRC processes
• Assists with preparing quarterly and annual update of KPIs
• Proactively manage files and systems needed to support the MRC review process including the maintenance of a central repository for all final copies complete with necessary signatures and supporting references
• Partners with MRC Global Manager in the planning and execution of any associated meetings and trainings
• Prepare for and actively participate in any and all QA checks and /or audits
• Assist in the maintenance of the Regeneron Reference Libraries working with project sponsors and the system vendor to ensure that said libraries are kept current and free of duplicates
• Liaise with initiating project sponsors on project timelines, and assist with project planning from submission for review through to distribution of approved materials

This role may be for you if:

• Outstanding communication skills, both written and verbal
• Proactive, self-motivated, and able to work well in dynamic environment
• Highly detail oriented and organized with ability to deliver on deadlines while managing multiple projects effectively

To be considered for this role, you must have a minium of a BS/ BA degree or advance degree preferred and 5 years of experience working with a Medical Affairs Review Committee (MRC) or other type of materials review committee (including Clinical Review Committees, Marketing Materials Review Committees, Regulatory Review Committees). We are seeking Strong customer service ethic with demonstrated ability to interact with management, customers, vendors and partners. Proficiency skills in Word, Excel, Power Point, Adobe Acrobat Professional required; Other systems including Zinc MAPS, Veeva Vault/PromoMats preferred.