Baton Rouge, LA3 days ago
Counsel on applicable laws, regulations, and guidance, including:FDA promotional requirements and enforcement trendsFTC advertising and endorsement requirementsCAN-SPAM and related digital marketing requirementsFederal Anti-Kickback StatuteFalse Claims ActOIG guidance and enforcementPhRMA Code and other industry considerationsState law considerations relevant to promotional and commercial practicesProvide legal guidance on common commercial and engagement tactics, including:Speaker programs and speaker trainingPatient ambassador and testimonial programsInfluencer and creator campaignsAdvisory boards and consultant engagementsCopay, patient support, and reimbursement-related communicationsMarket research, sponsorships, donations, and grantsMaintain a deep and current awareness of evolving applicable laws and regulations, as well as interpretations, advisory comments, enforcement actions and policy issues;Effectively partner with colleagues in Commercial, Promotion Compliance, Privacy, Compliance, Regulatory Affairs, Medical Affairs, Corporate Affairs, and/or Marketing Operations to respond to issues requiring legal support;Provide guidance to multi-functional teams to ensure compliance with company policies and legal/regulatory requirements; andPerform other legal, administrative and corporate duties upon request. Lead in legal review through the Promotional Review Committee, as assigned, and related review forums for:Consumer and HCP promotional materialsDigital, social, and print advertisingSales training materialsMarket access and payer-facing materialsField medical and medical information materialsCorporate affairs and external communications contentPatient support and disease awareness materialsAdvise sales, marketing, and commercial stakeholders on day-to-day business tactics, campaigns, and brand strategy in a manner consistent with legal, regulatory, and compliance requirements.