Associate Manager, Medical Review Committee-Medical Affairs Operations

Location
Tarrytown, NY, United States
Posted
Jul 06, 2019
Ref
16895BR
Required Education
Bachelors Degree
Position Type
Full time
Associate Manager Medical Affairs Operations

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

Medical Affairs at Regeneron

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases. As an important function within Regeneron, Medical Affairs serves as an important liaison between Regeneron and the scientific and healthcare community. Medical Affairs is organized in an optimally aligned matrix structure for delivery of therapeutic and functional area expertise.

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.

Job Duties:
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.


Requirements:
  • 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.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.