[Hiring] Assistant General Counsel @Telix Pharmaceuticals (AMER)

Role Description

The Assistant General Counsel, Americas serves as the lead attorney and strategic legal partner for Telix's Phase 3 and go-to-market activities in the Americas region, the company's largest market by revenue and headcount. The role covers the full Phase 3-to-commercial product lifecycle:

• Food and Drug Administration labeling and promotional/advertising review
• Medical-Legal-Regulatory (MLR) review committee participation
• Healthcare fraud and abuse compliance (Anti-Kickback Statute safe-harbor analysis, False Claims Act risk)
• Patient support program design and compliance
• Market access and government pricing (Medicare, Medicaid, 340B Drug Pricing Program, state drug pricing transparency laws)
• Specialty distributor and specialty pharmacy contracting
• Commercial medical affairs activities
• Antitrust and unfair competition law as applied to commercial activities
• Litigation/dispute management

This is a growth role for a lawyer who wants to build a career in pharmaceutical product counseling while embedded with Americas commercial, medical affairs, and market-access leadership.

Qualifications

• Juris Doctor (JD) from an accredited law school; active bar admission in at least one United States state required.
• 8-12+ years of legal practice with significant Food and Drug Administration promotional/labeling, healthcare compliance, pharmaceutical commercialization, market access, and/or commercial healthcare litigation experience.
• At least 4 years of in-house experience at a pharmaceutical, biotechnology, or life sciences company strongly preferred.
• Substantive knowledge of United States healthcare fraud and abuse laws.
• Experience with promotional review processes and Food and Drug Administration advertising and promotion requirements.
• Experience advising on market access and government pricing.
• Experience managing outside counsel and adhering to litigation and advisory budgets.
• Familiarity with antitrust/unfair competition law in the pharmaceutical commercial context preferred.

Requirements

• Serve as the primary legal business partner to Americas commercial, marketing, sales, and medical affairs leadership.
• Advise on Food and Drug Administration labeling strategy and regulatory compliance requirements.
• Serve as legal lead on Medical-Legal-Regulatory (MLR) promotional review committees.
• Advise on Anti-Kickback Statute safe-harbor analysis and healthcare fraud and abuse compliance.
• Counsel on patient support program design and compliance.
• Advise on market access and government pricing.
• Draft, review, and negotiate complex commercial agreements.
• Advise on antitrust and unfair competition law.
• Manage and oversee litigation and dispute matters in the Americas.
• Coordinate with Compliance on field activity compliance risks.
• Develop and maintain playbooks, templates, and compliance training materials.
• Effectively manage outside counsel relationships and budgets.
• Provide Americas clinical trial support.
• Structure HCP/KOL engagement programs with appropriate design and compliance considerations.

Benefits

• Competitive salaries
• Health and wellbeing incentives
• Bonus incentives
• Support for learning and development
• Generous vacation and paid wellness days