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.
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.
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
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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.