About Upsher Smith
At Upsher-Smith, we strive to improve the health and lives of patients by manufacturing and marketing brand and generic pharmaceutical products across multiple therapeutic areas. Our work is always backed by our attentive level of service, strong industry relationships and dedication to uninterrupted supply.
Job Summary
The Upsher-Smith Sr. Director Legal Affairs will provide strategic, proactive legal counsel to ensure compliant growth and risk management across the organization. The role develops and provides strategic vision and direction across Legal and key commercial and corporate interfaces, translating company strategy into multi-functional legal and risk-management priorities. This role enables the business to execute commercial strategies while meeting U.S. and global regulatory requirements. This position will be onsite/hybrid with residency in the Twin Cities metropolitan area.
Essential Functions
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Key Responsibilities
1) Commercial, Supply Chain, Licensing & Distribution Contracts & Transactions
- 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 Agreements
- Maintain contract playbooks and clause libraries; align with Finance and Compliance.
- Establish enterprise-wide contracting strategy and governance for significant commercial and strategic transactions.
2) Promotional & Advertising Legal Review
- 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.
- Set strategic direction for promotional legal review and risk mitigation, anticipating developments that may affect company strategy and market position
3) Compliance & Ethics (Commercial)
- 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.
4) Pricing, Market Access & Distribution
- Review pricing strategies, rebate structures, patient affordability programs, and value-based contracting (as applicable).
- Support trade strategy: GPO/IDN contracting, Retail/Wholesaler GPO’s, specialty pharmacy agreements, chargeback/reconciliation frameworks.
- Provide executive-level legal counsel on complex, high-impact pricing, market access, and distribution decisions.
5) Pricing, Market Access & Distribution
- 5) Investigations, Disputes & Outside Counsel Management
- 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.
- Direct legal strategy for matters with potential company-wide impact, including executive-level reporting, budget stewardship, and engagement with external stakeholders.
6) Training, Enablement & Governance
- Deliver onboarding and periodic training for Commercial teams.
- Establish governance cadence (monthly risk reviews, quarterly policy updates) with Commercial leadership.
- Lead the development and implementation of enterprise legal and compliance governance priorities in partnership with executive leadership
7) Strategic Partner with 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.
- Develop and execute a multi-year Legal Affairs strategy aligned to company objectives, translating it into cross-functional legal priorities and operating plans.
- Serve as a trusted advisor to senior and executive leadership, reconciling diverse stakeholder perspectives and influencing strategy on matters of significant organizational impact.
- 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.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
Minimum Education, Experience and Skills
- 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 Experience
- 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.
Working Conditions
- Onsite/Hybrid position with residency in Twin Cities metropolitan area.
- Travel: Minimal travel (<10%) for sales meetings, national conferences, and vendor audits (as needed).
- Work Hours: Align to commercial cadence; occasional evening/quarter-end workloads for contracting or launches. Occasional evening meetings to coordinate activities with Taiwan based HQ.
Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
