Upsher-Smith · 11 hours ago
Legal Counsel - In House
Upsher-Smith Laboratories LLC is seeking a Legal Counsel to provide strategic and proactive legal advice to support compliant growth and risk management. The role involves drafting and negotiating various contracts, ensuring compliance with regulatory requirements, and partnering with leadership to manage legal risks.
Health CareInformation Technology
Responsibilities
Draft, review, and negotiate: Sales & Distribution agreements (wholesalers, GPO’s, drug chains, specialty distributors, 3PLs)
Market access agreements (rebate, chargeback, payer contracting)
Promotional services (agencies, speakers bureaus, MSL collaboration boundaries)
CDAs and the management of USL and 3rd Party confidential information
Vendor MSAs/SOWs, HCP consulting and advisory agreements, event sponsorships
Patient support program agreements (hubs, copay vendors, affordability programs)
Supply Chain (supply agreements, manufacturing agreements)
Purchase agreements including acquisition and divestiture agreements
Licensing and Development Agreements including external drug development and co-development agreements; Strategic Partnership Agreement
Maintain contract playbooks and clause libraries; align with Finance and Compliance
Serve as legal reviewer on Drug Promotion Review Team for claims substantiation, fair balance, use of real-world evidence, social/digital campaigns, and field tools
Ensure alignment with FDA/FTC guidelines, product labeling, and risk communications
Provide training to assure legal and regulatory compliance anti-trust, foreign and domestic anti-corruption laws, government programs including Medicare/Medicaid, FDCA, DSCSA, PDMA, Sunshine Laws, and other applicable state and federal laws, regulations and industry guidelines applicable to the Company and its Affiliates
Interpret and operationalize False Claims Act, Sunshine Act/Open Payments, state marketing codes, and privacy requirements impacting commercial activities
Partner with Director of Compliance to Advise on HCP interactions, meals/sponsorships, grants & donations, speaker programs, and field force conduct
Partner with Director of Compliance to update policies, SOPs, and monitoring plans
Work with, or oversee the work of the Legal Affairs
Review pricing strategies, rebate structures, patient affordability programs, and value-based contracting (as applicable)
Support trade strategy: GPO/IDN contracting, Retail/Wholesale GPO’s, specialty pharmacy agreements, chargeback/reconciliation frameworks
Lead internal fact-finding for commercial incidents, coordinate outside counsel for disputes, general litigation or regulatory inquiries
This position oversees and manages general litigation activities including counsel selection, budgeting, litigation strategy, document production and interactions with outside counsel
Manage legal holds, document preservation, and remediation plans
Deliver onboarding and periodic training for Commercial teams
Establish governance cadence (monthly risk reviews, quarterly policy updates) with Commercial leadership
Recognize and anticipate a wide, and broad, variety of legal issues and business risks; communicate Company leadership the nature of issues and risks and recommend remediation plans
Develop legal and business strategies with respect, or in response, to proposed business opportunities, legal developments and proposed legislation
Stay abreast of and communicate industry laws, legal matters and regulations that impact strategy and business operations
Responsible for maintaining a positive corporate legal posture and advising the leadership team on risk management
Qualification
Required
A Juris Doctor (JD); admitted to practice in Minnesota
10 years of legal experience in the pharmaceutical, healthcare or medical device industry
3 years In-House counsel experience
Experience with commercial litigation and litigation strategy
Technical expertise in contracts, promotional review, pricing/market access, HCP engagements, distribution/trade, and compliance frameworks
Business-oriented judgment, negotiation excellence, stakeholder management, crisp written/oral communication, and project prioritization
Track record of collaborating well with cross-functional colleagues
Knowledge and ability to understand and apply laws and regulations; ability to analyze a situation and generate solutions
Preferred
Prior experience with generics and branded pharmaceuticals
Experience with pre-launch commercialization, generic and rare specialty products
Familiarity with global frameworks (e.g., HIPAA/Privacy, transparency regimes)
Exposure to digital and field sales promotion (social media, field CRM enablement, speaker programs, congresses) within regulated constraints
Experience with supply chain, distribution and other 3rd party agreements
Experience working in a global organization
Company
Upsher-Smith
Upsher-Smith Laboratories, LLC is a trusted U.S.
Funding
Current Stage
Late StageTotal Funding
unknown2024-01-16Acquired
Leadership Team
Taku Nakaoka
chairman and CEO
Recent News
2025-11-26
Company data provided by crunchbase