Associate Director, Brand Counsel

Responsibilities

• Act as the legal advisor to brand, marketing, market access, and commercialization teams
• Partner with cross-functional stakeholders to support launch planning and commercialization strategy
• Strategically advise teams on legal risks and offer practical solutions related to brand positioning, customer engagement, and commercialization initiatives
• Support development of a best-in-class commercialization model for innovative psychiatric therapies
• Serve as a core member of the Promotional Review Committee (PRC) and Medical Review Committee (MRC)
• Review and approve promotional materials directed to healthcare professionals, patients, and caregivers
• Advise on market-shaping activities, disease education communications, provider engagement strategies, and launch materials
• Counsel teams regarding FDA, the Office of Prescription Drug Promotion (OPDP), Federal Trade Commission (FTC), and federal and state law requirements applicable to pharmaceutical promotion
• Support legal review of sales training materials, websites and digital assets, print media, speaker program materials, advisory board materials, Medical Affairs materials
• Help establish promotional review standards, policies, and governance processes for a pre-commercial organization transitioning to launch

Requirements

• Juris Doctor (J.D.) from an accredited law school.
• Active membership in at least one U.S. state bar.
• Minimum of 5 years of legal experience, including significant pharmaceutical or biotechnology industry experience.
• Demonstrated expertise in FDA-regulated advertising and promotion.
• Experience working within MLR review processes.
• FDA and OPDP requirements
• Healthcare fraud and abuse laws
• Pharmaceutical compliance frameworks
• Regulatory review and launch preparation

Preferred

• Experience supporting launch or pre-launch pharmaceutical products.
• Experience in psychiatry, neuroscience, central nervous system (CNS), rare disease, or specialty pharmaceutical products.
• Familiarity with REMS programs, controlled substances
• Experience supporting Marketing, Market Access, and Medical Affairs
• Prior experience helping build legal frameworks and governance processes in a growing commercial organization.

Benefits

• - 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• - 401(k) program with company match and vesting after the turn of the first month after your start date
• - Flexible time off
• - Generous parental leave and some fun fringe perks!