| The Corporate Counsel, Pharmaceutical Regulatory Advertising and Promotion, will provide strategic legal support for a wide variety of company operations involving the FDA, including PARC meetings. ESSENTIAL FUNCTIONS Provide counsel and attend Promotional Advertising and Review Committee meetings for support of existing drugs and for the launch of new drugs. Review promotional material and corporate website for compliance with all applicable laws, rules, regulations and industry standards. Provide Legal support and guidance for all product labeling and labeling supplements prior to submission. Provide legal support for the review and development of policies, SOPs, and other internal governance documents. Advise and provide support to General Counsel, Chief Compliance Officer and various business units on regulatory matters and other related legal matters. REQUIRED EDUCATION J.D. admitted to practice the Illinois State Bar or other State Bar REQUIRED SKILLS AND EXPERIENCE 3+ years of legal experience with a healthcare-related law firm, regulatory agency, or pharmaceutical company in Advertising and Promotion function Must have excellent knowledge of DDMAC functions and understanding of industry standards and FDA Regulatory Law. Familiarity with laws and regulations impacting pharmaceutical manufacturers, including Food, Drug, Medicare, and product liability laws, as well as relevant state laws and regulations. Experience drafting and reviewing written policies. Excellent verbal and written communication skills. Ability to make effective decisions. Must be highly self-motivated. Effective interpersonal skills. The position requires initiative, creativity, flexibility and the ability to work with other corporate divisions. PREFERRED EDUCATION, SKILLS AND EXPERIENCE Bachelor’s degree in life sciences CB* BSP~ |