Review Committee Specialist, Commercial Operations

Location
Sleepy Hollow, NY, United States
Posted
Nov 20, 2020
Ref
22019BR
Required Education
Bachelors Degree
Position Type
Full time
The Review Committee Specialist is the lead for coordinating the activities of the Regeneron Review Committee, ensuring the production of high quality, compliant materials in a timely and efficient manner. Specifically this person is responsible for tracking projects from inception through production, maintaining appropriate systems and documentation files, and coordinating any associated regulatory submissions. Additionally, this individual is 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.
  • Liaise with initiating project sponsors on project timelines and assist with project planning from submission for review through to distribution of approved materials.
  • Review projects submitted for accuracy; verify and route submissions appropriately; provide proactive guidance on submissions where needed prior to committee approval.
  • Serve as the facilitator for assigned Review Committee meetings ensuring that reviews are conducted according to all policies and procedures and that all outcomes are accurately recorded.
  • Ensure that all required revisions are incorporated in to all impacted materials in a timely manner.
  • Help to coordinate the submissions of materials to the FDA Office of Prescription Drug Promotion ("OPDP") as required.
  • Proactively manage all files and systems needed to support the 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 training.
  • Prepare for and actively participate in any and all QA checks and /or audits.
  • Help to manage all associated processes including communications with vendors, system updates and the incorporation of enhancements.
  • 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.
  • Remain abreast of changes in the marketplace and new guidances as issued.


REQUIREMENTS:
  • Bachelor's degree required
  • 3-5 Years of experience including related promotional review experience, preferably in advertising, medical education or pharmaceutical marketing.
  • Experience managing a Legal, Medical, Regulatory (LMR) review committee.
  • Strong customer service ethic with demonstrated ability to interact with management, customers, vendors and partners.
  • Experience working with/for a co-promote brand
  • Experience working across multiple therapeutic areas
  • Detail-orientated with strong problem-solving and conflict resolution skills.
  • Able to deliver on deadlines while managing multiple projects effectively.
  • Outstanding communication skills, both written and verbal.
  • Proactive, self-motivated, and able to work well in dynamic environment.
  • Familiar with the drug development and commercialization process.
  • Proficiency with Adobe Acrobat Professional, Veeva PromoMats, Veeva Vault, MS Excel, MS Word, and MS Power Point
  • Certificate in Project Management a plus.

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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