Promotion Integrity - Director
Summit, NJ US
Position: Regulatory Advisor
Location: Summit, NJ
Duration: 6+ Months Contract
- 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
- 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 guidance’ s
- 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.