Director Advertising & Promotions

The Director Advertising & Promotion provides strategic regulatory advice, risk assessment, and mitigation strategies to support the advertising and promotion of assigned products in accordance with business goals and objectives, FDA regulations/guidances, PhRMA guidelines and company policy. The primary responsibilities of this role, Director Advertising & Promotion, are to: • Provide leadership for and manage regulatory aspects of the LMR review / approval process for product promotional materials, maintain compliance of promotional materials with the governing FDA regulations, and submit promotional materials to OPDP in a timely fashion; • Provide risk assessment and mitigation strategies for maximizing the commercial aspects for the marketing of assigned products while ensuring compliance with FDA promotional regulations; • Advise the Corporation on relevant new and existing regulatory risk and compliance requirements and provide regulatory expertise, advice, and support to Sales & Marketing and other product-related teams and the Legal Medical Regulatory team (LMR). Provide colleagues in RA and allied functions with cutting edge guidance on requirements and changes; • Contribute to the development and implementation of Corporate and Department procedures and policies for regulation of marketed promotional materials; • Strategize cross-functionally in product labeling negotiations to optimize language and enable commercial to create impactful promotional claims; • Provide recommendations to the RA strategists on Global Project Teams to ensure that regulatory strategy will result in commercially viable US labeling upon which future promotion and advertising will be based (Target Product Profile); • Mentor Regulatory Advertising personnel. Required Qualifications: • Bachelor of Science degree with extensive Pharmaceutical industry experience; • Experience in understanding the regulations and applying them to innovative channels to help move the organization forward; • Expert knowledge of US regulations for drug promotion/advertising and US labeling required; • Experience in the regulatory review of drug advertising and promotion required; • Proven ability to analyze and interpret efficacy and safety data; • Strong understanding of business goals of the involved business franchise, marketing concepts and tools required; • Must perform independently with strong negotiation and decision making skills; • Must be able to work in a multi-disciplinary environment;. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now.