Assistant General Counsel, Americas

Overview

This role serves as the lead Americas attorney and strategic legal partner for Phase 3-to-commercial activities in the Americas region. Responsibilities span the full product lifecycle, including Food and Drug Administration (FDA) labeling, promotional and advertising review, Medical-Legal-Regulatory (MLR) review committee participation, healthcare fraud and abuse compliance, patient support program design and compliance, market access and government pricing, specialty distributor and specialty pharmacy contracting, commercial medical affairs support, antitrust and unfair competition law as applied to commercial activities, and litigation/dispute management.

The position provides substantial autonomy as the primary, trusted legal point of contact for Americas commercial and medical affairs leadership, proactively partnering with business teams and escalating high-risk issues as appropriate.

Key Accountabilities

• Serve as the primary legal business partner to Americas commercial, marketing, sales, and medical affairs leadership, providing strategic, solutions-oriented counsel for downstream legal matters from Phase 3 development through commercial product lifecycle management.
• Advise on FDA labeling strategy, post-market commitments, Risk Evaluation and Mitigation Strategies, expanded access, and regulatory compliance requirements for approved and near-approval radiopharmaceutical products.
• Act as legal lead on Medical-Legal-Regulatory (MLR) promotional review committees; assess promotional and non-promotional materials (including digital, social media, and field-force content) for off-label risk, fair balance, claims substantiation, and compliance with FDA advertising and promotion requirements.
• Advise on Anti-Kickback Statute safe-harbor analysis, False Claims Act risk, healthcare fraud and abuse compliance, Sunshine Act/Open Payments transparency obligations, and interactions with Healthcare Professionals, Key Opinion Leaders, patients, patient advocacy organizations, and payers.
• Counsel on patient support program design and compliance, including co-pay assistance, hub services, specialty pharmacy relationships, and patient engagement programs, ensuring alignment with federal and state healthcare fraud and abuse frameworks.
• Advise on market access and government pricing (Medicare, Medicaid, 340B Drug Pricing Program, and Veterans Health Care Act pricing obligations), state drug pricing transparency laws, payer/group purchasing organization contracting, specialty distribution arrangements, and commercial launch readiness for the Americas market.
• Draft, review, and negotiate complex commercial agreements with healthcare-community counterparties, including hospitals, clinics, payers, specialty pharmacies, pharmacy benefit managers, diagnostic partners, and patient/professional advocacy organizations.
• Advise on antitrust and unfair competition law as applied to commercial activities, pricing strategies, distribution arrangements, and competitive intelligence programs.
• Manage and oversee litigation and dispute matters in the Americas, coordinating with outside counsel, maintaining budget discipline, and reporting material litigation risk to the Group General Counsel.
• Coordinate with Compliance on field activity compliance risks, speaker programs, advisory boards, Medical Science Liaison interactions, and evolving healthcare enforcement trends; monitor government enforcement actions and settlement developments related to pharmaceutical promotion.
• Develop and maintain playbooks, templates, escalation guidance, and compliance training materials for recurring Americas commercial legal matters; proactively identify process-improvement and efficiency opportunities.
• Manage outside counsel relationships and budgets for Americas commercial and litigation matters with spend discipline and measurable outcomes.
• 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 design, value-exchange, antitrust, distribution, and compliance considerations.

Position Requirements

Education and Experience

• 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.

Knowledge and Experience

• Substantive knowledge of United States healthcare fraud and abuse laws, including Anti-Kickback Statute and its safe harbors, False Claims Act, Sunshine Act/Open Payments, Stark Law (as applicable to pharmaceutical arrangements), and relevant Office of Inspector General compliance guidance and Department of Justice enforcement precedent.
• Experience with promotional review processes (Medical-Legal-Regulatory/Promotional Review Committee), FDA advertising and promotion requirements, and labeling/claims substantiation for pharmaceutical or biologic products.
• Experience advising on market access, government pricing (Medicare, Medicaid, 340B Drug Pricing Program), state drug pricing transparency and reporting laws, and/or specialty distribution/pharmacy contracting preferred.
• Experience managing outside counsel, adhering to litigation and advisory budgets, and driving measurable spend efficiency.

Preferred Experience

• Familiarity with antitrust/unfair competition law in the pharmaceutical commercial context.
• Experience with patient support program compliance and/or life sciences litigation (product liability, government investigations, commercial disputes).

Key Capabilities

• Results-oriented with a focus on measurable outcomes.
• Strong communication skills with clear and concise stakeholder engagement.
• Ability to collaborate effectively across teams and share knowledge.
• Adaptability to changing priorities in a dynamic environment.
• Commitment to ethical behavior and integrity.
• Strong professional resilience.
• Commitment to continuous learning and development.

Compensation & Benefits

• Competitive salaries.
• Annual performance-based bonuses.
• Equity-based incentive program.
• Generous vacation and paid wellness days.
• Support for learning and development.

Location

Hybrid and remote employees located all around the world. Americas-focused role.