HireDiversity

Horsham, PA, US

Manager, Regulatory Advertising & Promotion-1317121129

Description

Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.

The Manager, Regulatory Advertising and Promotion provides expert regulatory direction and oversight of advertising and promotion and marketing compliance related activities and serves as liaison to the Food and Drug Administration's (FDA) Office of Pharmaceutical Drug Promotion (OPDP, formally DDMAC) for assigned products. This individual ensures that promotional materials and activities are consistent with the respective product labeling, FDA and Johnson & Johnson regulations and guidelines. This individual, through the interpretation and application of relevant laws, regulations, guidelines, and company policies, helps ensure compliance and compliant growth of the business by providing strategic and tactical regulatory support and addressing issues/opportunities with alternatives to achieve desired outcomes. The Manager, Regulatory Advertising and Promotion provides leadership and advice regarding regulatory, promotional labeling and marketing compliance considerations in the R&D and commercial arenas.

Qualifications


A minimum of a Bachelor's degree is required. A focused degree in a health science or related field is highly preferred. An advanced degree (MS, PhD, Pharm D, JD, MBA, etc.) is desirable. A minimum of 3 years of experience working in a highly regulated industry is required. Experience in pharmaceutical and/or biotech industry is preferred. Candidates with direct experience in pharmaceutical Regulatory Affairs, Regulatory Advertising and Promotion, FDA's OPDP, or participation as a reviewer in promotion review committee meetings are highly preferred. Basic knowledge of FDA promotional practice laws, regulations, policies, guidelines and enforcement trends is required. A demonstrated track record of leading interactions with the FDA and/or OPDP is preferred. Familiarity with Web-based communications (e.g., chat or blog posting, widgets, RSS-feeds) and portable digital technologies (e.g., iPad, smart-phones) is desirable. Demonstrated ability to successfully lead project teams and train, mentor and influence behavior at multiple levels of management is required.

Excellent written and verbal communication skills are required. Strong influencing and negotiating skills that enable the creative achievement of mutual goals are required. The ability to work with management as well as with project level business colleagues from multiple functional areas is required. Strong interpersonal and technical skills are required to facilitate collaborations between Johnson and Johnson companies. This candidate will have proven experience driving progress and remaining focused under ambiguous and complex situations. In addition, this candidate will have strong consultant and leadership skills.

This position will be based in Horsham, PA and require up to 10% domestic travel.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies

Primary Location:North America-United States-Pennsylvania-Horsham
Organization: Johnson & Johnson Services Inc. (6090)
Job Function: Regulatory Affairs