Sr Mgr Reg Affairs Advertising & Promo Ops
- Military veterans preferred
2024-04-07 Arcutis Biotherapeutics Inc
Other
/yr
employee
contract
Westlake Village California 91361 United States
The Senior Manager, Regulatory Affairs Advertising & Promotion Operations is responsible for providing regulatory review, process coordination, and editorial review on the Arcutis Material Review Committee (AMR).
Roles & Responsibilities
Reviewer Responsibilities include:
Understand and evaluate all perspectives (Commercial, Legal/Compliance, Medical) and provide expert regulatory guidance for select materials for relevant products and associated therapeutic areas to cross-functional teams.
Review materials in Veeva Vault and actively participate in AMR meetings.
Complete various regulatory research projects, competitive intelligence reviews, etc. as needed.
Manage product label updates to ensure materials are revised, resubmitted for AMR Review, and submitted to FDA on form 2253.
Coordinator Responsibilities include:
Serve as the lead Coordinator for Medical AMR, scheduling meetings, routing of materials, agenda management, blacklining in meetings, perform periodic review assessments.
Collaborate with Commercial AMR coordinator to ensure consistency and reviewer bandwidth.
Oversight and QC of 2253 submissions process by working with Reg Ops and vendor to ensure compliant and timely submissions.
Fulfill promotional material audit requests from FDA and other internal parties, as needed.
Editorial Responsibilities include:
Serve as backup AMR Editor for reviews and Check Changes, as needed.
Education & Licenses and Experience
Bachelor’s degree from an accredited four-year college or university.
3+ years of biotech/pharmaceutical industry experience preferred.
Competencies & Skills
3+ years of direct Promotional Committee Review process operations experience
3+ years of related experience working in cross-functional teams for related industries.
Strong understanding of the role of Ad Promo and the regulatory requirements for the promotion of prescription drugs.
Extensive experience with Veeva Vault.
Collaborative in nature, able to work within a cross-functional team to ensure compliance while meeting the needs of the commercial and medical organizations.
Excellent verbal and written communication skills are required.
Why Join Us?
Arcutis is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases and our pipeline is one of the more robust and exiting in the industry. Our vision is to revitalize the standard of care for dermatological diseases and conditions through novel therapies that simplify disease management for physicians and patients. We are focused on filling the innovation gap in medical dermatology drug development by applying our deep clinical, product development and commercial expertise in dermatology to develop best-in-class therapies against biologically validated targets. Arcutis is uniquely positioned to become the preeminent innovation-driven medical dermatology company, and we are looking for top talent to join our team. We are nimble, collaborative, and passionate about achieving our mission!
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
Equal Opportunity Employer, including disability/protected veterans
