Date: 28-Jan-2014
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please visit http://biotech.fyicenter.com/
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.
To apply for this position, please visit
this Website.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
