Overview

The North America Legal team advises leaders and employees within North America Interventional Urology, Chronic Care, and Wound & Skin Care business areas on a wide variety of legal issues and matters involving multiple substantive areas of law. These areas include general corporate, litigation, employment, business, and commercial issues as well as industry specific issues. The team provides counsel, guidance, legal and contract support, and partnership in a highly regulated and complex legal environment that spans the medical technology and medical supply service (Durable Medical Equipment) industries. The team advises business clients on industry specific issues in the US and Canada including: the Federal Anti-kickback Statute (AKS), the False Claims Act (FCA), HIPAA, Marketing and Promotional issues, FDA and Regulatory issues, Compliance issues, Clinical issues, Reimbursement issues, and other federal, state, and Canadian laws applicable to a medical device manufacturer and durable medical equipment supplier.

The Legal Counsel provided legal support for assigned business areas within region North America. As a subject matter expert, this individual collaborates with other legal and functional experts to ensure that material legal issues are identified, quickly and clearly communicated to management, and efficiently resolved.

Major Areas of Accountability

  • Serve as primary legal counsel and chief legal advisor to leaders in areas of responsibility at the VP, Director levels and their team.
  • Provide legal advice, guidance and support to business clients in areas of responsibility
  • Proactively and independently communicates to leaders and stakeholders on legal matters and projects, and influences decision making
  • Primarily supports the Interventional Urology business
  • Advises other functions, and Compliance and Legal Depts., regarding their policies
  • Identifies gaps and opportunities for improvement within area of responsibility and assists in implementation of improvements
  • Manages projects to advance the legal and business objectives
  • Assesses legal risks in areas of responsibility and develops appropriate, optimum, risk mitigation strategies in collaboration with business and other support functions
  • Independently communicates with external third parties (competitors, distributors, customers, outside counsel) regarding legal claims, best practices and contract negotiations
  • Manages and directs efforts of outside counsel
  • Prepares, reviews, and negotiates a wide variety of contracts and agreements for the assigned business areas, including: Supply, Distribution, GPO; Product Sales, Marketing, Quality, Clinical, Research, and other agreements.
  • Review and advise on promotional materials
  • Advise on Marketing and Physician Relations programs and initiatives
  • Provide Regulatory advice and guidance
  • Provide Clinical advice and guidance
  • Integrates with the business to provide sound, practical legal guidance and solutions.
  • Identifies, creates and implements best practices around the preparation and negotiation of contracts.
  • Other duties as assigned

Authorities (non-exhaustive list)

  • Approve contracts
  • Approve promotional materials

Basic Qualifications

  • Juris Doctorate from US accredited law school
  • Licensed attorney in the US and able to be admitted to the Bar in Minnesota
  • Minimum 5-8 years legal experience as a practicing attorney
  • Previous experience working in-house preferred
  • Previous experience in healthcare, pharmaceutical or medical device company required
  • Experience providing legal advice and legal support for a medical device company or pharmaceutical company.
  • Ability to travel up to 15% of the time

Competencies

  • Understand and analyze complex legal and business issues
  • Effectively develop and articulate legal arguments in written and oral formats
  • Effectively communicates complicated facts and laws
  • Demonstrated ability to multi-task and manage multiple priorities
  • Must be proactive, flexible, responsive and resourceful
  • Demonstrated ability to work both independently and as member of a small team
  • Uses good judgement to provide legal advice that demonstrates an understanding of overall business objectives and the relative risks.
  • Demonstrated ability to effectively articulate position and provide direction to questions from a variety of internal and external customers in a fast-paced environment
  • Strong negotiation skills
  • Experience and Proficient knowledge in a minimum of three or more of the following legal areas:

Anti-kickback statute; False Claims Act; HIPAA and Privacy issues; FDA and Regulatory law regarding medical devices; Clinical trials; Medical Device Marketing & Promotional issues; Medical device Compliance issues; Supply Chain agreements and issues; Quality agreements and issues; Government Investigations

Skills

  • Good written and oral communication skills for internal and external audiences at all organizational levels.
  • Work product presentation and communications must instill confidence of underlying quality in business environment.

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