Sr. Legal & Compliance Counsel (Remote)

Denver, CO
Full Time
10-09-2021
Job #: REQ-3528 Exp.: 6+ Years Salary: $130,000 - $170,000 Yearly
Description:
Position Purpose: This position reports directly to the Head of Legal & Compliance, Americas for PHC Group and is responsible for providing legal analysis and guidance to business partners across various functions within the PHC Group of companies (primarily Ascensia Diabetes Care and its sister company, Epredia).

Location: Parsippany, NJ; Denver, CO; Valhalla, NY; Portsmouth, NH; Kalamazoo, MI; or remote candidates may be considered

Salary Range: ~$130,000 to $170,000, depending on experience

Major Tasks and Responsibilities of Position:
  • Provide strategic legal counsel to Commercial Heads within the Americas Region as well as global functions, including Operations, Procurement, Regulatory, Quality and Medical on a broad range of legal matters.
  • Support complex business transactions, including drafting and negotiating critical contracts, e.g., Consulting and Master Services Agreements, Confidentiality Agreements, IT Agreements, OEM Supply Agreements, Distribution Agreements, Strategic Alliance Agreements, Logistics Agreements, etc.
  • Provide legal support on new product launches to help identify and mitigate risks in a highly regulated medical device industry.
  • Provide efficient, solutions-oriented advice to ensure PHC Group Companies are in compliance with relevant laws and regulations, e.g., Open Payments regulations, the Anti-Kickback Statute, Stark Law, False Claims Act, Medicare/Medicaid Fraud & Abuse laws, Foreign Corrupt Practices Act, HIPAA, import/export laws, and antitrust laws.
  • Identify, evaluate, and help support on compliance issues, applying good judgment and an understanding of business, legal, and regulatory principles related to medical devices and the healthcare industry.
  • Provide advice on marketing programs and contracted services, in view of the highly-regulated nature of the medical device industry.
  • Participate in the Legal, Medical and Regulatory (LMR) reviews of promotional materials, with the ability to anticipate problems and initiate actions to propose solutions.
  • Work closely with the Strategic Contracting team by supporting contract negotiations for retail rebate business, while demonstrating the ability to think creatively about challenging business situations and adapt to changing environments and priorities.
  • Handle other legal matters as may be assigned by Head of and/or other members of the Legal, Patents & Compliance department for PHC Group, including special projects, research support and advice across a wide range of legal areas.

Qualifications:
  • JD from a nationally recognized law school
  • Licensed to practice in at least one US state or the District of Columbia
  • 6+ years of legal experience, including at least 3 years of experience drafting and negotiating contracts
  • Experience in medical device/healthcare industry and knowledge of FDA and FTC regulations is preferred.
  • Ability to prioritize, plan, and organize heavy workloads, while exercising discretion and independent judgment.
  • Ability to work autonomously and as a member of local and global teams.
  • Ability to learn quickly, synthesize input from a variety of sources, and think critically and strategically about ethics, risk and compliance.
  • Excellent analytical skills and communication skills (both verbal and written), with a high level of attention to detail.

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