Description

You will serve as the primary legal advisor for assigned pharmaceutical brands, providing strategic and day-to-day legal support across the full product lifecycle. You'll ensure all materials comply with company standards and applicable laws while partnering with cross-functional teams to mitigate legal risks and enable business objectives. This role involves representing Legal on the Medical, Legal, and Regulatory review committee and counseling on FDA regulations, healthcare laws, and industry standards.

Requirements

• Juris Doctorate Degree from ABA accredited law school
• Active member of California or New Jersey State Bars or qualified as Registered In-house Counsel
• Eight or more years of relevant legal experience
• Experience within the healthcare/pharmaceutical industry is required
• Previous product counsel experience preferred
• Strong knowledge of FDA advertising and promotion regulations, healthcare compliance laws, and industry standards
• R&D, clinical, and/or labeling experience is preferred
• Experience with AI governance is a plus

Responsibilities

• Act as lead legal counsel for assigned pharmaceutical brands across pre-launch, launch, and post-launch phases
• Provide strategic legal guidance on brand strategy, messaging, and execution
• Serve as Legal representative on the Medical, Legal, and Regulatory review committee
• Provide legal advice on FDA labeling, clinical operations, marketing strategies, and healthcare professional engagements
• Counsel on federal and state healthcare laws including Anti-Kickback Statute and False Claims Act
• Proactively identify risks and collaborate across business functions to implement mitigating actions
• Assist with employment law matters and investigations as needed
• Stay informed of new laws, regulations, and industry trends affecting the company