Regeneron Pharmaceuticals Associate Manager, Medical Review Committee (MRC) in Tarrytown, New York
The MRC Associate Manager will assume a lead role in overseeing and coordinating the activities of the MRC, 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 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.
The MRC Associate Manager will:
Leads the for Medical Affairs Review Committee (MRC) process
Facilitate delivery of materials to MRC.
Ensure delivery and receipt of assets to senior medical management for their review as needed.
Proactively manage all 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.
Assume a lead role 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.
Coordinate with alliance counterparts on submission status for related jobs and overall system management as needed.
Qualifications and skills:
Bachelors degree preferred. Two years of equivalent experience will be accepted in lieu of a degree.
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).
Highly detail oriented and organized with ability to deliver on deadlines while managing multiple projects effectively.
Strong customer service ethic with demonstrated ability to interact with management, customers, vendors and partners.
Outstanding communication skills, both written and verbal.
Proactive, self-motivated, and able to work well in dynamic environment.
Proficiency skills in Word, Excel, Power Point, Adobe Acrobat Professional required; Other systems including Zinc MAPS, Veeva Vault/PromoMats preferred.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
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