Associate Director, Promotional Regulatory Affairs

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 Associate Director, Promotional Regulatory Affairs is responsible for providing regulatory review of advertising and promotional materials, and other Commercial and Medical Affairs communications, 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.

Essential Functions of the Job (Key responsibilities)

* Works closely with representatives from Marketing, Legal, and Medical Affairs in the development of compliant, compelling, and competitive advertising and promotional materials.

* Represents Promotional Regulatory Affairs on the Scientific Material Review and Approval Team to review and approve scientific and other non-promotional material

* Provides strategic input into regional labeling, corporate communications, and clinical study development plans as needed.

* Ensures advertising and promotional materials are updated to be consistent with revised labeling.

* Delivers regulatory compliance training to members of 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.

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 3 years' experience in pharmaceutical industry that includes direct experience in review of advertising and promotional material in a high growth, fast-paced pharmaceutical environment.

* Direct experience as liaison with OPDP is preferred.

* Knowledge of Labeling, Advertising and other applicable regulation and guidance.

* Experience in Dermatology therapeutic area, or other highly competitive therapeutic areas, is preferred.

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.

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