Director, Legal

Role Overview:

• Serve as the lead legal reviewer for promotional and medical materials, representing Legal in the MLR review process.
• Report to the VP, Commercial Legal, and provide practical legal guidance across advertising, promotion, medical affairs, commercial operations, market access, and product launch planning.

Key Responsibilities:

• Sit on the Promotional Review Committee and Medical Review Committee, reviewing materials for compliance with the FD&C Act, FDA regulations, FTC requirements, and industry codes.
• Advise on pre-approval communications, scientific exchange, patient support programs, and digital/social content.
• Review non-promotional materials including unsolicited requests, payor communications, and corporate messaging to ensure regulatory alignment.

Qualifications:

• JD from an accredited law school with active membership in at least one U.S. state bar.
• 6+ years of legal experience in the pharmaceutical, biotechnology, or life sciences industry.
• Strong knowledge of FDA advertising and promotion regulations, product launch planning, and commercialization activities.

Core Competencies:

• Strong business judgment with a practical, solutions-oriented approach to risk management.
• Ability to influence and advise in a matrixed environment and translate complex legal concepts into actionable guidance.
• High degree of autonomy, accountability, and execution focus in a fast-paced, remote environment.