This position is responsible for providing regulatory review of advertising and promotional materials, and other Commercial and Medical Affairs communications, in order to ensure compliance with company policies, FDA regulations and guidelines, and other Health Agency regulations. The position also provides strategic and operational regulatory leadership concerning advertising and promotional issues to assigned project teams.
Summary of the Essential Functions of the Job
Works closely with representatives from Marketing, Legal, and Medical Affairs in the development of advertising and promotional materials.
Ensures compliance with applicable FDA and state regulations and those of other Regulatory Agencies.
Provides input into labeling, company-sponsored educational seminars, content of displays at major meetings, responses to physician inquiries, and other communications.
Ensures advertising and promotional materials are updated to be consistent with current labeling.
Delivers regulatory compliance training to members to cross-functional teams as needed.
Participates in the development of commercial compliance policies to support the commercial interests of the business.
Serves as point of contact with the FDA Office of Prescription Drug Promotion (OPDP) and directs the timely submission of all applicable approved promotional materials to the FDA and to other Regulatory Agencies, as required.
Manages the maintenance of records and databases that support communication with OPDP and other Regulatory Agencies.
Maintains awareness of the promotional regulatory environment with the FDA and understands international/global promotional issues.
Other responsibilities, as necessary.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte is an equal opportunity employer.
BS/MS or Ph.D., PharmD in a scientific discipline or equivalent experience.
Minimum of 5 years experience in pharmaceutical industry that includes direct experience in promotion and advertising and commercial compliance in a high growth, fast-paced pharmaceutical environment.
Direct experience as liaison with OPDP.
Broad knowledge of Labeling, Advertising and other applicable regulations.
Knowledgeable in both State and Federal requirements regarding commercial compliance in advertising and promotion.
Experience in oncology/accelerated approval promotion would be advantageous.
Knowledge and experience of European/International requirements for promotion of ethical pharmaceuticals would be advantageous.