Counsel, US Market Access and Operations

ModernaTX • Princeton, NJ

4d • Onsite

About The Position

Moderna is seeking a Counsel, Market Access and Commercial Operations to take responsibility for providing legal support for the commercialization of the Moderna COVID-19 Vaccine in the U.S. and, over time, other assets transitioning to commercialization in the United States. This position will be the primary point of contact for the U.S. Market Access and U.S. Commercial Operations teams.

Requirements

• Juris Doctor and admitted to the bar in good standing in at least one jurisdiction
• 8+ years of experience in-house or at a law firm supporting the pharmaceutical or biotech industry required

Nice To Haves

• Experience advising on legal issues (e.g., fraud and abuse, antitrust) related to marketed pharmaceutical products
• Experience drafting, reviewing, and negotiating complex contracts
• Experience supporting contracting with payors and in the US channel space, including wholesalers and distributors, integrated delivery networks, and retailers preferred
• Experience with federal government contracting a plus
• Strong understanding of pricing and reimbursement in the pharmaceutical marketplace in the U.S.
• Experience in pharmaceutical government price reporting a strong plus
• Experience in vaccines a plus
• Ability to perform legal analyses and counsel business partners independently, with a focus on delivering solutions-oriented advice
• Excellent communication, presentation, collaboration and influencing skills across internal and external stakeholders
• Intense sense of urgency, curiosity, and ambition to excel and build something from the ground up, navigating all the requisite ambiguity and complexity that comes with writing the rulebook while executing in real time
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Responsibilities

• Provide legal advice on fraud and abuse laws and regulations (Anti-Kickback Statute, False Claims Act) and antitrust laws and regulations (Robinson-Patman, Sherman Act) for strategies and tactics related to commercialization
• Advise on and provide contract support for major market access contracts, including wholesaler/distributor, retailer, health systems, GPOs and large employers
• Provide strategic advice on pricing strategy and communications
• Support the government price reporting function, including advising on price reporting policies and methodologies, communicating with related regulatory authorities, and analyzing impact of pricing or contracting proposals on reported government prices
• Support the response to federal government solicitations for procurement of vaccines
• Advise on legal issues related to the development and launch of a digital direct purchasing platform
• Provide legal advice on state distribution licensure, government contract compliance, and the Drug Supply Chain Security Act and its implementing regulations
• Collaborate with Compliance to mitigate enterprise risk generally, including supporting the drafting and implementation of SOPs and policies
• Serve as business partner while also providing clear legal advice that communicates the magnitude of legal risks and identifies decision rights

Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree