Lead the US advertising and promotional compliance strategy for assigned products
Review US promotional and non-promotional/scientific material, attending review meetings and providing regulatory guidance
Serve as primary contact for communications with the Office of Prescription Drug Promotion and/or Advertising and Promotional Labeling Branch for assigned products
Provide training support on regulatory requirements for prescription drug promotion
Provide advice to product development teams on advertising and promotion issues
Maintain stakeholder awareness of proposed and newly approved labeling changes
Collaborate with their manager and Medical Legal Regulatory Coordinator in developing processes and procedures
Maintain regulatory expertise in product promotion compliance
Communicate new regulatory standards to brand teams and management

Bachelor’s Degree
Minimum 5 years of relevant experience and/or relevant PharmD post-doctoral Fellowship experience
5 years of U.S. advertising and promotional regulations
Experience communicating and negotiating directly with OPDP and/or APLB
Experience with global standards for advertising and promotion compliance
Proven 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
Experience with launching new products and/or new indication
Solid understanding of business goals and common marketing concepts/tools, including the internet and social media
Proficiency using promotional review software, such as Veeva Promomats and Veeva Medcomms

Health, dental, and vision coverage in accordance with the terms of the applicable plans
Qualified retirement programs
Paid time off (i.e., vacation, holiday, and leaves)
Eligibility for various incentives—short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles

Associate Director, Advertising and Promotional Compliance

Key skills