Review Committee Specialist

The Review Committee Specialist (Oncology International) will partner with key stakeholders to support the business unit's submission, review and approval of promotional assets outside the US. The role will report directly to the Director, Marketing Operations (Oncology International).

Specifically, this individual will be responsible for providing day-to-day support of Regeneron’s Medical, Legal, Regulatory (MLR) review process and related system across various geographies, including Europe, Canada and Japan.

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 Duties;

• Manage overall MLR process and related system training (e.g., Veeva PromoMats) for internal reviewers and sponsors as well as external agency partners

• Guide sponsors of promotional materials on review cycle timelines and processes from planning to submission, review and 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 all required revisions are incorporated in to all impacted materials in a timely manner

• Work with local teams to help coordinate content localization and submissions of materials to regulatory authorities as required

• Monitor performance and compliance metrics and advise on process enhancements

• Ensure all sponsors and agencies adhere to the promotional review standards

• Proactively manage all files and systems needed to support the review process

• Prepare for and actively participate in any and all quality assurance checks and /or audit.

Job Requirements;

• Experience managing a Medical, Legal, Regulatory (MLR) review committee/process

• Strong customer service ethic with demonstrated ability to interact with management, customers, vendors and partners

• 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

• English speaking (multilingual preferred - e.g. German, French, Italian, Japanese) Preferred

• Certificate in Project Management a plus

• Minimum bachelors degree

• Minimum 2-3 years experience