Director, US Advertising and Promotional Compliance

Accountabilities

• Reviewing US promotional, non-promotional, and scientific material, attending review meetings and providing regulatory guidance to the cross-functional team responsible for ensuring adherence to compliance standards and FDA regulations pertaining to prescription drug advertising, promotion, and communication as applicable
• Serving as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB) for assigned products
• Developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials: Developing best practices, working instructions and/or SOPs to establish standards and consistency across company brands
• As needed, providing training support within Alexion on requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific congresses and conferences
• Advising product development teams on advertising and promotion issues to facilitate the strategic development of new products
• Maintaining regulatory expertise in product promotion and compliance by keeping current with issued FDA enforcement actions and through attendance of relevant conferences and/or seminars. Communicate new regulatory standards pertaining to prescription drug promotion to brand teams and management, as appropriate
• Participating in and supporting ongoing key initiatives including the development, implementation, and continued improvement of promotional review process
• Supporting and mentoring ad/promo colleagues

Essential Skills/Experience

• Bachelor’s degree
• 7+ years pharmaceutical industry in regulatory affairs and/or advertising and promotion
• Expertise in US advertising and promotional regulations and the current regulatory environment
• Experience communicating and negotiating directly with OPDP and/or APLB
• Experience leading a team or experience having direct reports
• Experience with global standards for advertising and promotional compliance
• Excellent written and verbal skills and strong interpersonal skills
• Consistent track record practicing sound judgment as it relates to risk assessment
• Knowledgeable on industry compliance requirements and non-compliance examples and trends
• Demonstrated ability to influence others and foster team collaboration
• Strong interpersonal, communication, and leadership skills!

Desirable Skills/Experience

• JD, PharmD or master’s degree preferred