Temp - Review Committee Specialist
About The Position
The Review Committee Specialist leads coordination of Regeneron’s promotional Review Committee (Medical, Legal, and Regulatory) activities and ensures promotional review processes are compliant, timely, and efficient. The role tracks promotional materials from inception through approval, maintains supporting systems and documentation, coordinates associated regulatory submissions, and maintains and enforces operating procedures. It also facilitates high-quality committee meetings, supports continued compliance with applicable laws, policies, and procedures, and guides promotional material sponsors in submitting high-quality, compliant work. The role is based in Sleepy Hollow, New York. Regeneron states that many roles are required to be performed on-site; applicants should confirm the expectations for this role with the recruiter or hiring manager.
Requirements
- Bachelor’s degree.
- Excellent written, verbal, and interpersonal communication skills, with the ability to interact effectively with internal and external stakeholders at all levels and establish credibility with project-team professionals.
- Strong presentation and critical-thinking skills.
- Exceptional organizational and time-management skills, including the ability to manage multiple projects and priorities.
- Ability to thrive in a fast-paced, entrepreneurial organization and handle ambiguity and uncertainty.
Responsibilities
- Guide promotional material sponsors on review-cycle timelines and assist with planning from submission through approval.
- Review promotional materials for accuracy, verify and route submissions appropriately, and provide proactive guidance before Review Committee approval.
- Facilitate assigned Review Committee meetings, ensuring reviews follow policies and procedures and outcomes are accurately recorded.
- Ensure required revisions are incorporated into all impacted materials in a timely manner.
- Help coordinate submissions of materials to the FDA Office of Prescription Drug Promotion (OPDP) as required.
- Proactively manage files and systems needed to support the review process.
- Prepare for and actively participate in quality assurance checks and audits.
- Help manage associated processes, including vendor communications, system updates, and incorporating enhancements.
- Remain abreast of marketplace changes and newly issued guidances.
Benefits
- Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, a 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.
