General Counsel

• Serve as legal counsel to the Company’s market access function
• Provide legal strategy, advice, and contracting support for market access initiatives related to Company products
• Work with market access, commercial, sales, and other business teams on market access strategy, payer and PBM arrangements, contracts, specialty pharmacy and provider agreements, distribution channels, contract operations, government pricing, reimbursement, and regulatory and compliance issues
• Draft, review, and negotiate market access contracts, including payer, specialty pharmacy, provider discount agreements, distribution agreements, and licensing deals
• Support litigation and dispute resolution related to market access and reimbursement issues
• Identify legal risks associated with patient services and payer, specialty pharmacy, and provider contracts and develop mitigation strategies
• Draft, review, and negotiate manufacturing, supply, commercialization, marketing/sale, wholesaler/distribution, master services, statements of work, market access, and managed care agreements
• Advise on laws and regulations concerning pharmaceutical product development, manufacture, and commercialization, including market access, payer agreements, patient support services, product liability, and corporate transactions
• Provide legal support and negotiate terms for government-supported agreements with the Department of Defense and BARDA agreements and consortia
• Prepare compliance matrices and flow-down terms templates for government-supported agreements
• Draft, review, and negotiate contracts implementing government-supported agreements
• Advise on customer contracting, pricing, price reporting, FD&C Act, and anti-kickback issues
• Support business development, including regulatory, promotional activity, social media, and patient support services due diligence
• Identify, allocate, and mitigate legal risk affecting Shionogi
• Review and interpret existing contracts and advise business partners on contract requirements
• Independently manage assigned legal matters, advise business leaders on legal risk and options, and escalate material risks as appropriate
• Perform other duties as assigned

Senior Corporate Counsel, Market Access, Government Contracts

• Act as counsel for NA Ventures on advertising, marketing, competition law, consumer promotions, contract negotiation, contract disputes, litigation, manufacturing, corporate governance, compliance, intellectual property law, and data privacy
• Contribute to corporate and business unit strategic goals as a proactive member of the legal team and functional partner with business and specialist counsel
• Partner with the NA Ventures Legal Lead to set and execute legal strategies anticipating changes in laws, regulations, and the business environment
• Collaborate with the North America Legal Commercial team on legal strategy and cross-functional initiatives
• Develop and provide best-practices training to internal stakeholders
• Work with the Legal Operations Lead to select and retain competent, cost-effective outside counsel and experts
• Develop relationships with outside counsel, frame performance goals, guide work efforts, and monitor performance against budget
• Report to the Director & Senior Counsel, Give & Go and NA Ventures Legal Lead

Counsel, NA Ventures

• Review, draft, negotiate, and close commercial contracts, including vendor product and services agreements, employment agreements, and healthcare-related agreements
• Provide rapid, practical, business-oriented legal and commercial contract guidance to businesspersons
• Support negotiations involving pricing, deliverables, service scope, warranties, and other commercial terms
• Interpret and explain contract terms and conditions to corporate stakeholders
• Apply practical business judgment to maximize revenues, minimize risk, and foster long-term clinical and business partner relationships
• Identify complex issues requiring escalation to senior legal team members
• Assist more senior counsel and management with higher-level matters
• Report to the Senior Counsel—Healthcare and Operations
• Collaborate on and facilitate cross-team decision-making among internal teams
• Work with outside counsel on matters requiring specialized expertise
• Manage assigned projects through completion
• Perform additional responsibilities supporting the mission of improving the lives of people living with cancer

Counsel, Commercial & Operations

• Advise OneOncology corporate teams and affiliated and managed clinical practices on healthcare regulatory matters
• Advise on the federal Anti-Kickback Statute, Stark Law, False Claims Act, and analogous state fraud, abuse, and self-referral laws
• Structure, paper, and document physician, vendor, and referral source arrangements within applicable safe harbors and exceptions
• Review, draft, negotiate, and close healthcare and commercial contracts across the OneOncology network
• Advise on HIPAA and state health information privacy and security requirements
• Counsel practices and corporate stakeholders on licensure, scope of practice, supervision and delegation, corporate practice of medicine, fee-splitting, and certificate of need requirements
• Monitor federal and state healthcare law and agency guidance and translate developments into policies, playbooks, contract templates, and training
• Partner with Compliance on regulatory questions, internal reviews, remediation, and responses to payor and government inquiries
• Provide practical legal and contract guidance and support negotiations on pricing, deliverables, services, and commercial terms
• Identify complex issues requiring escalation to senior Legal team members
• Facilitate cross-team decision-making with compliance, revenue cycle, operations, integrations, and human resources
• Work with outside counsel on matters requiring discrete expertise
• Manage assigned projects to completion
• Assist senior counsel and management with higher-level matters

Counsel, Regulatory

• Advise Walmart Connect on legal rights, obligations, and risks
• Architect legal frameworks for expanding offsite media offerings through partnerships and acquisitions
• Act as a translator between Walmart corporate governance and a startup culture
• Explain policies, controls, and risk requirements in practical terms
• Design legal frameworks, governance programs, and contract infrastructure for new products and services
• Negotiate high-stakes MSAs, DPAs, digital advertising insertion orders, and platform terms
• Support privacy teams’ assessments for products involving GDPR, CCPA/CPRA, and SOC 2
• Provide legal advice, risk mitigation, regulatory compliance, and legal strategy

Senior Counsel – Offsite Media, CTV

• Serve as lead legal advisor to Global Product Development
• Counsel senior executives on business strategies and complex, high-value transactions across the pharmaceutical and biologics pipeline
• Negotiate, structure, and draft material development and supply transactions, including CMO/CDMO agreements
• Support legal due diligence on business development opportunities
• Support manufacturing, operations, and supply aspects of M&A and BD deals
• Support asset integration into the product development network
• Draft and negotiate assignment, manufacturing, material transfer, and bill of sale agreements
• Negotiate and draft drug development, procurement, manufacturing, laboratory, and research agreements
• Advise on enterprise-wide manufacturing strategy
• Identify potential risks and establish mitigation strategies
• Guide the Product Development & Supply team through alliance-related issues
• Partner with IP colleagues to protect and leverage product development innovations
• Lead process optimization and integration initiatives
• Streamline transactional legal support across the enterprise
• Collaborate across the Law & Policy Department and with business clients to deliver coordinated legal advice

Counsel, Global Product Development

• Serve as legal advisor to Pharma and Biologics Operations on complex legal, regulatory, and operational matters across the global manufacturing network
• Provide transactional and comprehensive legal support for internal and external manufacturing operations, including PDS Business Development matters
• Lead drafting and negotiation of highly complex CMO, manufacturing and supply, and collaboration agreements
• Support manufacturing, operations, and supply aspects of BMS M&A and business development transactions, including due diligence and integration
• Anticipate and proactively identify legal issues with an enterprise view
• Deliver clear, operational, and effective advice supporting informed business decisions
• Lead and organize functional and substantive working groups assessing significant legal issues
• Collaborate across the Law & Policy Department with business clients and colleagues to deliver coordinated, comprehensive legal advice

General Counsel jobs in New Jersey