The North America Legal Team (Chronic Care and Wound & Skin Care)
The North America Legal team advises leaders and employees within North America 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.

Job Summary / Purpose

The Senior Legal Counsel serves as the primary legal counsel for a business unit or assigned business areas within region North America. This individual applies a high degree of subject matter expertise and uses his or her broad legal background to collaborate with other legal and functional experts to ensure that material legal issues are identified, quickly and clearly communicated to senior management, and efficiently resolved. As an influential leader in the business, the Senior Legal Counsel impacts and helps set strategic direction across areas of responsibility.

Essential Duties / Responsibilities

• Serves as primary legal counsel for assigned business unit and areas of responsibility, and as primary legal advisor to those leaders at the VP level and their teams.
• Provide legal advice, guidance and support to business clients in areas of responsibility
• Proactively and independently communicates to leadership and other stakeholders on legal matters and projects, and influences critical decision making
• Provide legal advice, guidance and support to business clients in areas of responsibility
• In addition to supporting segments of the Chronic Care business and Global Operations team, the Attorney in this role would ideally also serve as the lead in-house Employment Law attorney for the organization and she/he will spend approximately 30% of her/his time advising and supporting Human Resources on Employment law issues.
• Prepares, reviews, and negotiates a wide variety of large, complex contracts and agreements including: Supply, Distribution, Product Sales, Marketing, and Quality Agreements.
• Review and advise on promotional materials for the Chronic Care business
• Advises with respect to business policies, particularly in areas related to the Chronic Care business, and Human Resources.
• Assesses legal risks across assigned business and areas of responsibility and develops appropriate, optimum, risk mitigation strategies in collaboration with the business and other support functions
• Independently communicates with external third parties (competitors, distributors, customers, trade groups, outside counsel) regarding investigations, legal claims, compliance related matters, best practices, and contract negotiations
• Integrates with the business to provide sound, practical legal guidance and solutions, often in situations that are ambiguous and undefined
• Manage and direct the efforts of outside counsel
• 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 for Chronic Care business

Basic Qualifications

• Juris Doctorate from US accredited law school
• Licensed attorney in the US and either: 1) admitted to the bar in Minnesota or 2) able to obtain an in-house liscence to practice in Minnesota
• Minimum 8-10 years of legal experience as a practicing attorney
• Previous experience working in-house preferred
• Previous experience in healthcare, pharmaceutical or medical device company preferred
• Working knowledge of industry specific legal issues applicable to Coloplast's businesses.
• Experience providing legal support in the following areas: (i) advising employers on employment law issues; (ii) negotiating and drafting commercial contracts
• 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 legal and business judgment to make decisions and provide 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
• Good stakeholder management skills
• Strong negotiation 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; Commercial contracting; Government contracting; Clinical trials; Sunshine Act; Medicare and Reimbursement issues; Medical Device Marketing & Promotional issues; Medical device Compliance issues; Corporate law; Supply Chain agreements and issues; Distributor agreements and issues; Quality agreements and issues; Manufacturing; Government Investigations; Litigation management; Anti-trust; Durable Medical Equipment issues; Employment Law

Skills

• Exceptional 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

Applicants located outside of the Minneapolis-St. Paul area will be considered.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12,000 people and with products available in more than 143 countries, we are one of the worlds 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.

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.