“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.
Help us improve CareerBuilder by providing feedback about this job:
Report this job
Report this Job
Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to ourTrust and Site Security Team
privacy and protection,
when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction.Learn more.
By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder
Terms and Conditions
for use of our website. To use our website, you must agree with the
Terms and Conditions
and both meet and comply with their provisions.