Senior Legal Counsel

The North America Legal Team

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 Coloplast’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
• Coloplast 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.

Competencies

• Understand and ability to 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 a collaborative member of a small team
• Uses excellent legal and business judgement to make decisions and provide legal advice that demonstrates an understanding and balancing 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
• Strong contract drafting skills
• Good stakeholder management skills
• Experience and Proficient knowledge in a minimum of five or more of the following legal areas:

Anti-kickback statute; False Claims Act; HIPAA and Privacy issues; FDA and Regulatory law regarding Medical Devices/Pharmaceuticals; Clinical trials; Reimbursement issues; Medical Device/Pharmaceutical Marketing & Promotional issues; Discount Safe Harbor and other laws applicable to Medical Device sales; Medical device/Pharmaceutical Compliance issues; billing requirements of a Medicare healthcare provider; Government Investigations

Skills

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

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Visit us on Coloplast.com.

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Coloplast 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.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

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