TEMP - Review Committee Specialist, Commercial Operations

Location
Sleepy Hollow, New York, United States of America
Posted
Jul 16, 2021
Ref
24476BR
Required Education
Bachelors Degree
Position Type
Full time
This is a temporary contract assignment estimated to be 6-9 months in length. This role can be a remote role.

The Review Committee Specialist role is the lead for coordinating Regeneron's promotional Review Committee (Medical, Legal, and Regulatory) activities and for ensuring the promotional review processes are conducted both in a highly compliant manner and in a timely and efficient manner. This role is responsible for tracking promotional materials from inception through approval, maintaining appropriate systems and documentation files, and coordinating any associated regulatory submissions. Additionally, this role is tasked with maintaining and enforcing associated operating procedures, managing high-quality committee meetings, ensuring continued compliance with all laws, policies and procedures, and providing guidance to promotional material sponsors on submission of high-quality and compliant work. Liaise with initiating promotional material sponsors on timelines and assist with planning from submission for review through to distribution of approved materials. Review promotional materials submitted for accuracy; verify and route submissions appropriately; provide proactive guidance on submissions where needed prior to Review 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. 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. Remain abreast of changes in the marketplace and new guidance as issued.

Requirements:
  • Bachelor's degree and 3-5 Years of experience including related promotional review experience, preferably in advertising, medical education or pharmaceutical marketing. Experience managing a Medical, Legal, Regulatory (MLR) 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.