Strategic Brand Counsel Lead – Pharma Launch

Definium Therapeutics; Durham (NC); Sur place; USD 175 000 - 220 000; Plein temps

Résumé du poste

Definium Therapeutics is seeking an Associate Director, Brand Counsel to act as a strategic legal partner across Commercial, Medical Affairs, Regulatory Affairs, Market Access, and Compliance. The attorney will shape legal and regulatory strategies for development, potential launch, and commercialization of Definium assets.

The role requires expertise in pharmaceutical advertising, strong business judgment, and experience navigating FDA-regulated promotion and MLR processes.

Qualifications

• J.D. from an accredited law school.
• Active membership in at least one U.S. state bar.
• Minimum of 5 years of legal experience in the pharmaceutical/biotech industry.
• Demonstrated expertise in FDA-regulated advertising and promotion.
• Experience working within MLR review processes.
• Strong understanding of FDA and OPDP requirements, healthcare fraud/abuse laws, and regulatory launch frameworks.

Responsabilités

• Serve as strategic legal partner to Commercial, Medical Affairs, Regulatory, Market Access, and Compliance teams.
• Advise on launch planning and commercialization strategies.
• Review and approve promotional materials directed to healthcare professionals, patients, and caregivers.
• Counsel on FDA, OPDP, FTC, and state law requirements applicable to pharmaceutical promotion.
• Support development of governance standards for pre-commercial to launch transition.

Connaissances

FDA advertising

MLR processes

Regulatory strategy

Pharma compliance

Formation

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

Description du poste

Definium Therapeutics is seeking an Associate Director, Brand Counsel to act as a strategic legal partner across Commercial, Medical Affairs, Regulatory Affairs, Market Access, and Compliance. The attorney will shape legal and regulatory strategies for development, potential launch, and commercialization of Definium assets.

The role requires expertise in pharmaceutical advertising, strong business judgment, and experience navigating FDA-regulated promotion and MLR processes.