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Senior Legal Counsel

Coloplast Corporation - US

This is a Full-time position in Minneapolis, MN posted February 21, 2021.

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.n nThe 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 cuntional experts, to ensure that material legal issues are identified quickly and clearly communicated to senior management, and efficiently resolves.

As an influential leader in the business, the Senior Legal Counsel impacts and helps set strategic direction across areas of responsibility.n n Major Areas of Accountability Serves as primary legal counsel for assigned business unit and areas of responsibility, and as primary legal advisor to those leaders at the VP levels 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 Primarily supports the Interventional Urology business Manages projects to advance the business and legal objectives Provide legal advice and support regarding Clinical studies and the Clinical research programs In addition, the Attorney in this role will serve as the lead in-house Regulatory attorney for the organization.

Prepares, reviews, and negotiates a wide variety of large, complex contracts and agreements including: Supply, Distribution, Product Sales, GPO, Marketing, Quality, Clinical, Research, and other Agreements.

Review and advise on Marketing and Physician Relations programs and initiatives Advises with respect to Marketing and Promotional materials Advises with respect to business policies, legal policies, and Compliance policies, particularly in areas related to the Regulatory, Clinical, Promotional, and Quality matters.

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 (regulators, competitors, distributors, customers, trade groups, outside counsel) regarding investigations, legal claims, regulatory and 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 n n Authorities (non-exhaustive list) Approve contracts Approve promotional materials n n 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 8-10 years legal experience as a practicing attorney Previous experience working in-house required 5-8 years previous experience in healthcare, pharmaceutical or medical device company required Working knowledge of industry specific legal issues applicable to Coloplast’s businesses.

Experience providing legal advice and support in the following areas: (i) Clinical Studies; (ii) FDA Regulatory issues; (iii) negotiating and drafting commercial contracts; (iv) promotional issues for medical devices or pharmaceuticals Ability to travel up to 15% of the time n n 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: n nAnti-kickback statute; False Claims Act; HIPAA and Privacy issues; FDA and Regulatory law regarding medical devices; Clinical trials; Reimbursement issues; Medical Device/Pharmaceutical Marketing & Promotional issues; Medical device/Pharmaceutical Compliance issues; Supply Chain agreements and issues; Quality agreements and issues; Government Investigations; Anti-trust; Durable Medical Equipment issuesn n 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 n nPursuing 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 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.n nVisit us on Coloplast.com.Watch the film.

Follow us on LinkedIn.

Like us on Facebook.n nColoplast 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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