Temp - Review Committee Specialist
Regeneron Pharmaceuticals
Summary
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.
Job description
Discover your role:
- Guide promotional material sponsors on review cycle timelines and assist with planning from submission for review through to approval.
- 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 guidances as issued.
This role requires:
- Minimal educational requirements: Bachelor’s Degree
- Have excellent written, verbal, and interpersonal communication skills and the ability to effectively interact with all levels both internal and external to the company in order to establish credibility with professionals on the project teams.
- Have strong presentation and critical thinking skills.
- Handle multiple projects and priorities with exceptional organizational and time management skills (both project and self)
- Thrive in fast paced entrepreneurial organizations; expert in dealing with ambiguity and uncertainty
Requirements
- Bachelor’s Degree
- Excellent written, verbal, and interpersonal communication skills
- Ability to effectively interact with all levels both internal and external to the company
- Strong presentation and critical thinking skills
- Handle multiple projects and priorities with exceptional organizational and time management skills
- Thrive in fast paced entrepreneurial organizations; expert in dealing with ambiguity and uncertainty
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.