Senior Counsel – Global Commercial Operations

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

📋 Description

• Accountable for advising Amgen’s Global Commercial Operations clients on a diverse range of legal and regulatory matters related to promotion, sales, patient support programs, contracting, education, and scientific exchange concerning biopharmaceutical products in the United States.

• Conducting analysis, review, and approval of promotional, educational, and support programs and materials.

• Evaluating, reviewing, and approving approaches for scientific exchange and clinical support.

• Offering guidance on proposed sales and marketing strategies.

• Reviewing and advising on government enforcement actions pertaining to the promotion of biopharmaceutical products.

• Delivering ongoing training to commercial operations personnel regarding legal and regulatory obligations for commercial activities within the biopharmaceutical sector.

• Advising on intricate commercial transactions involving members of the healthcare community (hospitals, clinics, payors, specialty pharmacies, pharmacy benefit managers, patient and professional advocacy groups/associations), with a specific focus on Federal and State Anti-Kickback and False Claims Statutes, as well as relevant antitrust laws.

• Analyzing and providing advice on precision medicine patient and provider programs for products that involve novel biomarkers with complex companion diagnostics.

• Anticipated 20% domestic travel.

⛳️ Requirements

• J.D. or LL.M. degree from an accredited law school, with admission to practice law in a U.S. jurisdiction and a minimum of four (4) years of legal practice experience.

• Over 6 years of experience in a corporate and/or law firm environment, providing counsel on healthcare/life sciences issues.

• Background in advising clients on complex legal and regulatory matters, including healthcare fraud and abuse, FDA promotional regulations, OIG compliance guidance and advisory opinions, DOJ settlements in the pharmaceutical sector, and Medicare/Medicaid reimbursement and contracting.

• Demonstrated exceptional legal skills, including excellent oral and written communication, legal analysis, drafting, and negotiation abilities.

• Capability to lead and influence teams.

• Strong focus on client service, business counseling, and problem-solving.

• Proficient in managing multi-dimensional projects in a dynamic environment.

• Outstanding academic credentials.

• Experience in analyzing and advising on precision medicine patient and provider programs for products that involve novel biomarkers and complex companion diagnostics.

🏝️ Benefits

• A comprehensive employee benefits package, which includes a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision insurance, life and disability coverage, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.