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US: Associate Director in Biotech

Date: 28-Jan-2014
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Associate Director in Biotech

Review and approval of advertising/promotional materials for marketed products, press, educational, and training materials as assigned Determine and provide strategic regulatory advice on advertising and promotion materials and activities in accordance with business goals and objectives Support and provide strategic guidance to the development of launch materials/new claims by collaborating with matrix partners, e.g. Marketing, Medical Affairs, Legal Assure full regulatory compliance of all promotional programs with approved labeling Provide assessment of risk for marketing and medical campaigns

BS required; advanced degree preferred (MS, PhD, PharmD, or JD) Minimum of 4 years Regulatory promotional review Experience providing strategic direction to interdisciplinary teams on promotional materials and activities related to the launch of a new pharmaceutical product Strong interest in the evolving landscape of FDA advertising and promotion regulations including FDA guidance(s) Proven ability to analyze and interpret efficacy and safety data Exposure to OPDP interactions related to promotional labeling activities Experience in the regulatory review of professional and consumer DTC Rx drug advertising and promotion in various media (print and virtual) preferred Detail & deadline oriented; well organized Excellent verbal and written communication skills Good interpersonal skills; ability to interact with staff across matrix partners Strong commitment to business ethics Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.

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