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Ad Promo Regulatory Advisor (21-04708) at Axelon Services Corporation

Ad Promo Regulatory Advisor (21-04708)

Axelon Services Corporation Lawrence Township, NJ Contractor
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“This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”

Job Description: Ad Promo Regulatory Advisor
- 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.

ADVERTISING, PROMOTIONAL REVIEW, AD-PROMO, REGULATORY PROMOTIONAL REVIEW, OFFICE OF PRESCRIPTION DRUG PROMOTION, PHARMA, REGULATIONS. 

Recommended skills

Communication
Pharmaceuticals
Leadership
Management
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