Assistant General Counsel, Americas

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the main legal business partner for the leadership teams in Americas commercial, marketing, sales, and medical affairs.

• Offer strategic legal advice from Phase 3 development through the complete product lifecycle management.

• Provide guidance on FDA labeling strategies, post-market obligations, REMS, expanded access, pipeline submissions, and regulatory compliance.

• Lead promotional review committees encompassing Medical-Legal-Regulatory aspects and evaluate promotional and non-promotional materials for off-label risks, fair balance, claims substantiation, and compliance with FDA regulations.

• Counsel on matters related to healthcare fraud and abuse compliance, Anti-Kickback Statute safe harbors, risks associated with the False Claims Act, Sunshine Act/Open Payments, and interactions with healthcare stakeholders.

• Advise on patient support initiatives, co-pay assistance, hub services, specialty pharmacy collaborations, and programs aimed at patient engagement.

• Provide expertise on market access, government pricing, drug pricing transparency, payer/GPO contracts, specialty distribution, and readiness for commercial launches.

• Draft, review, and negotiate intricate commercial agreements with healthcare counterparties.

• Offer counsel on antitrust matters and unfair competition laws relating to commercial activities, pricing, distribution, and competitive intelligence.

• Oversee litigation and disputes in the Americas, including managing outside counsel, budgets, and reporting material risks to the Group General Counsel.

• Collaborate with Compliance on field activities, speaker programs, advisory boards, MSL interactions, and enforcement trends.

• Create legal playbooks, templates, escalation guidance, and compliance training resources.

• Manage relationships with outside counsel and budgets with a focus on spending discipline.

• Provide support for Americas clinical trials, including CTAs, site agreements, investigator relationships, IITs, publications, medical affairs initiatives, advisory boards, and MSL frameworks.

• Design HCP/KOL engagement programs while ensuring adherence to legal and compliance standards.

⛳️ Requirements

• Juris Doctor (JD) degree from an accredited law school.

• Active bar admission in at least one U.S. state is mandatory.

• 8–12+ years of legal practice with substantial experience in FDA promotional/labeling, healthcare compliance, pharmaceutical commercialization, market access, and/or commercial healthcare litigation.

• A minimum of 4 years of in-house experience at a pharmaceutical, biotechnology, or life sciences company is highly preferred.

• In-depth understanding 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 precedents.

• Experience with promotional review processes, FDA advertising and promotion requirements, and claims substantiation/labeling for pharmaceutical or biologic products.

• Familiarity with advising on market access, government pricing, state drug pricing transparency/reporting laws, and/or specialty distribution/pharmacy contracting is preferred.

• Proven experience managing outside counsel, litigation and advisory budgets, and achieving measurable spend efficiency.

• Knowledge of antitrust/unfair competition law, compliance in patient support programs, and/or life sciences litigation is preferred.

• Excellent communication, collaboration, adaptability, integrity, and a commitment to continuous learning.

🏝️ Benefits

• Competitive salaries.

• Health and wellness incentives.

• Bonus programs.

• Support for learning and professional development.

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Hybrid and remote work options available company-wide.