Associate Director, Brand Counsel

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as a strategic legal partner for Commercial, Medical Affairs, Regulatory Affairs, Market Access, Corporate Affairs, and Compliance.

• Provide legal guidance to brand, marketing, market access, and commercialization teams.

• Collaborate with cross-functional stakeholders on launch planning and commercialization strategies.

• Offer advice on legal risks and practical solutions for brand positioning, customer engagement, and commercialization initiatives.

• Assist in the development of a commercialization model for innovative psychiatric therapies.

• Participate in the Promotional Review Committee and Medical Review Committee.

• Evaluate and approve promotional materials intended for healthcare professionals, patients, and caregivers.

• Provide counsel on market-shaping activities, disease education communications, provider engagement strategies, and launch materials.

• Guide teams on FDA, OPDP, FTC, and federal and state pharmaceutical promotion regulations.

• Review sales training materials, websites, digital content, print media, speaker program materials, advisory board materials, and Medical Affairs documents.

• Assist in establishing standards, policies, and governance processes for promotional reviews.

• Advise on FDA promotion and scientific exchange requirements, healthcare fraud and abuse laws, payment transparency, privacy and data protection, CAN-SPAM, price transparency, and compliance with the PhRMA Code.

• Collaborate with Compliance and Regulatory Affairs on risk assessments and mitigation strategies.

• Stay informed about emerging legal and regulatory developments impacting psychiatric therapies and novel treatment modalities.

⛳️ Requirements

• Juris Doctor (J.D.) from an accredited law school.

• Active membership in at least one U.S. state bar.

• A minimum of 5 years of legal experience, including substantial experience in the pharmaceutical or biotechnology industry.

• Proven expertise in FDA-regulated advertising and promotion.

• Experience with MLR review processes.

• Strong comprehension of FDA and OPDP requirements.

• Solid understanding of healthcare fraud and abuse laws.

• Strong grasp of pharmaceutical compliance frameworks.

• In-depth knowledge of regulatory review and launch preparation.

🏝️ Benefits

• 100% covered health benefits, including Medical, Dental, and Vision for you and your dependents.

• 401(k) program featuring company match and vesting after the first month post your start date.

• Flexible time off policy.

• Generous parental leave.

• Enjoyable fringe perks.

• Additional compensation may include bonuses and equity.