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29 Jan 2021

Temporary Ad Promo Regulatory Advisor (21-02106)

Axelon Services Corporation – Posted by iris.chen@axelon.com Lawrence Township, New Jersey, United States

Job Description

“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.
Additional Job Requirements:
None

How to Apply

Please send your updated resume to iris.chen@axelon.com

Job Types: Temporary.

Job expires in 61 days.

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