at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
The Senior Director, Promotional Regulatory Affairs position is responsible for providing strategic and operational leadership concerning Regulatory Affairs advertising and promotional issues across Incyte marketed products. The position reports to the Division VP, Global Regulatory Affairs and serve as head of the Promotional Regulatory Affairs group. The Senior Director leads a team, as well as personally take part in, providing regulatory review of advertising and promotional materials and other communications in order to ensure compliance with company policies, FDA regulations and guidances, and other Health Agency regulations.
Essential Functions of the Job (Key responsibilities)
Lead the Promotional Regulatory Affairs (PRA) function with overall oversight and accountability for PRA for Incyte marketed pharmaceutical products.
Manage direct reports and recruits, develops and retains high performing Promotional Regulatory Affairs professionals.
Expertly aware of the promotional regulatory environment with the FDA and understands international/global promotional issues.
Pursue knowledge of trends and changes in the regulation of pharmaceutical marketing to support the Incyte Commercial Organization.
Provide strategic analysis and interpretation of the regulatory framework governing the promotion of prescription drugs and biologics.
Work closely with representatives from Marketing, Legal, and Medical Affairs in the development of advertising and promotional materials and compliance policies to support the commercial interests of the business.
Ensure compliance with applicable FDA and state regulations and those of other Regulatory Agencies.
Provide input into labeling, company-sponsored medical educational materials, content of displays at major meetings, responses to physician inquiries, and other communications.
Ensure advertising and promotional materials are updated to be consistent with current labeling.
Deliver regulatory compliance training to members of Medical Affairs and Sales and Marketing, as needed.
Serve as the primary contact, leading and facilitating communications 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.
Manage the maintenance of records and databases that support communication with OPDP and other Regulatory Agencies.
Oversee processes and procedures relevant to the creation, review and approval of advertising, promotional and labeling materials for Incyte.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BS/MS or Ph.D., PharmD in a scientific discipline or equivalent experience.
Minimum of 10-15 years of experience in pharmaceutical regulatory affairs with at least 10 years of direct experience in promotion and advertising and commercial compliance in a high growth, fast-paced pharmaceutical environment. Direct experience with product launches and in the oncology therapeutic area preferred.
Direct experience as liaison with OPDP.
Broad knowledge of both State and Federal requirements regarding commercial compliance in advertising and promotion.
Knowledge and experience of European/International requirements for promotion of ethical pharmaceuticals would be advantageous.
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 Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy
Learn more at:
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful... For full info follow application link.
We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.