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.
• Identifies, creates and implements best practices around the preparation and negotiation of contracts.
• 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.

• Other job duties as assigned

Authorities (non-exhaustive list)

• Approve contracts

• Approve promotional materials and programs

Basic Qualifications

• Juris Doctorate from US accredited law school

• Licensed attorney in the US, admitted to the Bar in at least one jurisdiction, and have ability to obtain Virginia Corporate Counsel Registrant from the VA Board of Law Examiners

• Minimum 8-10 years legal experience as a practicing attorney

• Working knowledge of medical device industry, and specific legal issues applicable to a medical device business operating in the U.S.

• Experience negotiating and drafting a variety of types of complex commercial contracts, including medical device or pharma industry product sales contracts

• Previous experience working in-house preferred

• Experience providing legal advice and legal support or compliance support for a medical device company or pharmaceutical company.

• Experience providing legal advice in the following areas preferred: (i) promotional issues and materials for a medical device or pharmaceutical company; (ii) commercial sales of medical devices; (iii) AKS; (iv) FDA Regulatory issues .

• Ability to travel up to 15% of the time

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

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

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect:

• Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
• Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
• Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
• Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
• Community and Culture: A supportive work environment where everyone feels valued, and has a sense of belonging. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way
• Competitive Compensation: The compensation range for this position is $180,000 - $240,000. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.

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.

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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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