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Assistant General Counsel, Americas
Telix Pharmaceuticals Limited. Serve as the primary legal business partner to Americas commercial, marketing, sales, and medical affairs leadership .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in FDA promotional and labeling regulations, healthcare compliance, and pharmaceutical commercialization, with a strong focus on legal counsel throughout the product lifecycle. Proven ability to manage litigation, outside counsel relationships, and compliance training while advising on market access and pricing strategies.
Highest-signal resume keywords
Juris Doctor (JD)FDA Promotional/Labeling ExperienceHealthcare Compliance ExpertiseIn-House Pharmaceutical ExperienceLitigation Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory ComplianceCommercial Agreements NegotiationMarket Access StrategyPromotional Review ProcessesHealthcare Fraud and Abuse LawAntitrust Law KnowledgePatient Support Program ComplianceLitigation Budget ManagementFDA Advertising RequirementsClaims Substantiation
Soft Skills
Strong CommunicationCollaborationAdaptabilityEthical BehaviorContinuous Learning
Certifications & Qualifications
Active Bar Admission
Industry Keywords
Pharmaceutical CommercializationBiotechnologyLife SciencesAnti-Kickback StatuteFalse Claims ActSunshine Act/Open PaymentsStark LawOIG GuidanceDOJ EnforcementSpecialty Distribution
About the role
Key responsibilities & impact- Serve as the primary legal business partner to Americas commercial, marketing, sales, and medical affairs leadership
- Provide strategic legal counsel from Phase 3 development through commercial product lifecycle management
- Advise on FDA labeling strategy, post-market commitments, REMS, expanded access, pipeline submissions, and regulatory compliance
- Lead Medical-Legal-Regulatory promotional review committees and assess promotional and non-promotional materials for off-label risk, fair balance, claims substantiation, and FDA compliance
- Advise on healthcare fraud and abuse compliance, Anti-Kickback Statute safe harbors, False Claims Act risk, Sunshine Act/Open Payments, and healthcare stakeholder interactions
- Counsel on patient support programs, co-pay assistance, hub services, specialty pharmacy relationships, and patient engagement programs
- Advise on market access, government pricing, drug pricing transparency, payer/GPO contracting, specialty distribution, and commercial launch readiness
- Draft, review, and negotiate complex commercial agreements with healthcare counterparties
- Advise on antitrust and unfair competition law for commercial activities, pricing, distribution, and competitive intelligence
- Manage Americas litigation and disputes, including outside counsel, budgets, and material-risk reporting to the Group General Counsel
- Coordinate with Compliance on field activities, speaker programs, advisory boards, MSL interactions, and enforcement trends
- Develop legal playbooks, templates, escalation guidance, and compliance training materials
- Manage outside counsel relationships and budgets with spend discipline
- Provide Americas clinical trial support, including CTAs, site agreements, investigator relationships, IITs, publications, medical affairs programs, advisory boards, and MSL frameworks
- Structure HCP/KOL engagement programs with appropriate legal and compliance considerations
Requirements
What you’ll need- 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 FDA 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 U.S. healthcare fraud and abuse laws, including the Anti-Kickback Statute, False Claims Act, Sunshine Act/Open Payments, Stark Law, OIG guidance, and DOJ enforcement precedent
- Experience with promotional review processes, FDA advertising and promotion requirements, and labeling/claims substantiation for pharmaceutical or biologic products
- Experience advising on market access, government pricing, state drug pricing transparency/reporting laws, and/or specialty distribution/pharmacy contracting preferred
- Experience managing outside counsel, litigation and advisory budgets, and measurable spend efficiency
- Familiarity with antitrust/unfair competition law, patient support program compliance, and/or life sciences litigation preferred
- Strong communication, collaboration, adaptability, ethical behavior, and continuous-learning capabilities
Benefits
Comp & perks- Competitive salaries
- Health and wellbeing incentives
- Bonus incentives
- Support for learning and development
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Hybrid and remote work arrangements (company-wide)