Ascensia Diabetes Care Remote Sr. Legal and Compliance Counsel in Lowell, Massachusetts
Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people with diabetes.
About the role: If you are motivated by meaningful, impactful work, we invite you to join our team! 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).
PHC Group is a Japan-based healthcare company that develops, manufactures, sells, and services medical equipment and solutions across the fields of diabetes management, diagnostics, life sciences and healthcare IT. At PHC, we contribute to the health of society through our diligent efforts to create healthcare solutions that have a positive impact and improve the lives of people across the globe.
You can work remotely or from our new office in Denver, CO
Salary range: $130,000 to $170,000, depending on experience
What you will be doing:
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.
What you need for success:
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.
Ascensia is a Federal Contractor. Due to the Executive Order on vaccine mandates, vaccination or approved qualified exemptions may become a requirement for employment.
Ascensia offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and are driven by innovation and the desire to improve the lives of our patients, we encourage you to apply now. Job postings will remain open for a minimum of five business days and are subject to immediate closure thereafter without additional notice.
TO ALL RECRUITMENT AGENCIES:
Ascensia does not accept unsolicited third party resumes.
Ascensia is an Equal Opportunity Employer including Disability/Protected Veterans (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm) .
If you are interested in applying for employment with Ascensia and need special assistance or an accommodation to use our website, please contact us at ApplicantAccommodations@ascensia.com
Ascensia Diabetes Care
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