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Promotion Integrity - Director

Summit, NJ

Posted: 05/17/2022 Job Number: 17012172

Job Description


Position:  Regulatory Advisor

Location: Summit, NJ

Duration: 6+ Months Contract

 

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 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.

Meet Your Recruiter

Abhinav Kashyap

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