Description:

The North America Legal team advises leaders and employees within the North America Chronic Care, Wound & Skin Care, Interventional Urology, Voice & Respiratory Care, and Durable Medical Equipment provider businesses 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, Privacy, Marketing and Promotional issues, FDA and Regulatory issues, Compliance issues, Clinical issues, Reimbursement issues, Medicare billing and provider issues, and other federal, state, and Canadian laws applicable to a medical device manufacturer or durable medical equipment supplier.

Job Summary / Purpose
The Senior Legal Counsel serves as the primary Legal counsel for assigned businesses and areas within region North America, and serves as an influential leader in the businesses. As both a legal generalist and a subject matter expert, this individual applies a high degree of subject matter expertise with her/his broad legal background to collaborate with other functional experts and stakeholders to ensure that material legal issues are identified, quickly and clearly communicated to senior management along with recommendations, and efficiently resolved.

Essential Duties / Responsibilities:

Serve as primary legal counsel and chief legal advisor to leaders in areas of responsibility at the VP, Director levels and their teams.
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
Advises other functions, and the Compliance Dept. regarding their policies
Identifies gaps and opportunities for improvement within area of responsibility and assists in implementation of improvements
Participates in business projects to advance the legal and business objectives
Assesses legal risks across assigned business and in areas of responsibility and develops appropriate, optimized, risk mitigation strategies in collaboration with the business and other support functions
Independently communicates with external third parties (competitors, distributors, customers, outside counsel) regarding legal claims, promotional issues, 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, Insurance, GPO; Product Sales, Rebate, Marketing, Clinical, Research, vendor, Employment, and other agreements.
Review and advise on promotional materials
Advise on Marketing and Physician Relations programs and initiatives, and Patient Education programs and initiatives
Integrates with the business to provide sound, practical legal guidance and solutions, often in situations that are ambiguous and undefined.
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 and programs

Job Qualifications:

Juris Doctorate from US accredited law school
Licensed attorney in the US and able to be admitted to the Bar in Minnesota
Senior Legal Counsel: Minimum 8-10 years legal experience as a practicing attorney
Working knowledge of industry specific legal issues applicable to A Danish Multinational Company's businesses
Experience negotiating and drafting a variety of types of commercial contracts
Previous experience working in-house preferred
Previous experience in medical device, pharmaceutical, or with a healthcare provider preferred
Experience providing legal advice and legal support or compliance support for a healthcare provider, medical device company or pharmaceutical company preferred.
Experience providing legal advice in the following areas preferred: (i) promotional materials for a medical device or pharmaceutical company; (ii) AKS; (iii) FDA Regulatory issues; (iv) Medicare billing issues for a healthcare provider.
Ability to travel up to 15% of the time
A Danish Multinational Company employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.