Senior Counsel Attorney

• Commercial & Regulatory Advice: Advise Commercial Operations and Regulatory Affairs leadership on healthcare fraud and abuse risks associated with pricing, contracting, reimbursement, promotional activities and market access strategies
• Primary focus of commercial advice involves oversight of customer contracts with healthcare organizations, group purchasing organizations (GPOs), wholesalers, distributors, and healthcare professionals (HCPs)
• Counsel the business on fraud and abuse laws, discount safe harbors, value-based arrangements and other commercial and regulatory areas
• Must provide practical, business-focused guidance to enable compliant commercialization
• Compliance & Prevention: Develop internal expertise, programs and policies to ensure compliance with fraud and abuse laws, analyze contracts for potential risks, and provide practical advice to help structure legitimate business arrangements
• Ensure adherence to corporate Ethics & Compliance policies, including HCP engagements, speaker programs, advisory boards, grants and donations
• Contribute to the development and updates of policies and procedures
• Risk Mitigation: Identify, assess and mitigate fraud and abuse risks arising from commercial and regulatory activities
• Support internal investigations and responses to government inquiries related to commercial conduct
• Assist in the auditing of the business and development and execution of remediation strategies
• Cross-Functional Collaboration: Serve as a legal representative on enterprise and cross-functional teams and projects
• Stay Current: Monitor enforcement trends and other legal, regulatory, and governmental developments on fraud and abuse issues impacting the business
• Advise leadership of emerging risks related to innovative contracting and market access models
• External Counsel Management: Direct and lead outside counsel efficiently when needed

• Juris Doctor (JD) from an accredited law school
• admission to practice in relevant jurisdiction, active member in good standing
• Strong academic record
• Significant experience advising commercial teams in the healthcare/life sciences space on fraud and abuse laws
• In-house experience supporting a pharmaceutical and/or medical device company will be highly desireable
• Familiarity with regulatory frameworks governing medical devices and pharmaceuticals
• Strong understanding of pharmaceutical and/or medical device commercialization
• Exceptional oral written communication skills, including drafting skills and presentation capabilities
• Excellent interpersonal and conflict resolution skills and ability to work in a highly collaborative, team-oriented environment
• Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the business and other functions
• Self-motivating, working independently on projects, meeting aggressive deadlines, acting decisively, balancing multiple matters and a mentality of continuous improvement
• Proficiencies: Practical legal judgment, collaboration skills, and the ability to work independently with minimal direction

In-house experience supporting a pharmaceutical and/or medical device company

• Medical and dental coverage that start on day one
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• Educational assistance programs
• Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits