Senior Legal Counsel

The Coloplast North America Legal team advises leaders and employees within the North America business units of: Chronic Care (Continence & Ostomy), Advanced Wound Dressings/Kerecis; Interventional Urology, Voice & Respiratory Care/Atos, and Durable Medical Equipment providers, 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 strategic business 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, Quality issues, Discount Safe-Harbor and other laws related to the sales of medical devices, 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 Function Summary
The Senior Legal Counsel serves as the primary Legal counsel for assigned businesses and substantive 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. 

This role will be the primary attorney providing broad- based legal support and counsel for the Kerecis/Advanced Wound Dressings business in the U.S., with a focus on medical device industry specific issues and commercial support.

This strategic, legal business partner will become a member of the Kerecis management team, with a dotted line reporting relationship to Kerecis executive management and a solid reporting line to the Coloplast General Counsel, North America. The role will be located on site at the Kerecis main office in Arlington, Virginia; working in collaboration with other on-site and off-site members of the Coloplast North America Legal and Compliance teams. 

Major Areas of Accountability

• Serve as primary, and chief legal advisor to Kerecis 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
• Collaborates with Compliance in assessing and advising the business regarding its operational practices, and in establishing policies and procedures regarding business operations Advises other functions regarding their policies and practices
• 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, Compliance 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 medical device 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. <