Temp - Review Committee Specialist

Build our future together:

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.

When & where:

• Primary Location: Sleepy Hollow, NY
  

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

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.