Ad Promo Regulatory Advisor

Company: Pyramid Consulting, Inc
Location: New Brunswick
Posted on: June 22, 2022

Job Description:

- Provide regulatory advice and risk assessment on advertising/promotional materials, sales training materials, and external communications for marketed products, as assigned- Assure full regulatory compliance of all promotions with approved labeling, FDA guidance documents, and OPDP advisory comments- Maintain up-to-date knowledge of laws, regulations and policies enforced by the Federal and State governments as they relate to advertising and promotion of pharmaceuticals- Ensure timely and accurate submission of promotional materials to OPDP on Form 2253- Work with management to ensure that changes in US Prescribing Information are reflected in current promotions and advertising
Requirements- Bachelors Life Science degree required, advanced degree preferred (MS,PhD, PharmD, or JD)- Candidate should have a minimum of 5-6 years of regulatory promotional review experience- Candidate should have experience providing strategic direction to interdisciplinary teams on promotional materials for marketed products and strong interest in FDA advertising and promotional practice regulations, including guidances- Broad "hands on" related pharmaceutical experience or actual FDA regulatory experience- Demonstrated ability to manage various projects, solve problems, deliver on commitments, and work with multidisciplinary teams.- Strong leadership and organizational skills with demonstrated success in driving optimal business results in a complex matrix organization required.

Keywords: Pyramid Consulting, Inc, New Brunswick , Ad Promo Regulatory Advisor, Other , New Brunswick, New Jersey