MAJOR TASKS AND RESPONSIBILITIES OF POSITION:
- Draft and negotiate a variety of commercial agreements, including master services agreements, consulting services agreements, clinical trial agreements, confidentiality agreements, distribution agreements and other commercial and operational contracts.
- Provide strategic legal counsel to various stakeholders across multiple functions (e.g., Commercial, Regulatory, Medical and Clinical Affairs, Procurement, Operations and Quality) in support of all PHC Group Companies in Region Americas
- 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.
- Advise on existing and future collaborations and interactions with healthcare providers (HCPs) to ensure compliance with US and global compliance laws and regulations, including transparency reporting requirements for such HCP interactions;
- Provide advice on marketing programs and contracted services, in view of the highly-regulated nature of the medical device industry.
- Develop training documents, and provide training to internal stakeholders, in the areas of healthcare compliance and commercial transactions.
- 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.
- Implement best practices in compliance and contracts management.
- Admission to a state bar (with the ability to become licensed as an in-house counsel in NJ, if not otherwise licensed in NJ)
- 2-5 years of experience as a healthcare attorney
- Medical device experience 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
- Knowledge of FDA and FTC regulations is preferred
- Familiarity with the AdvaMed Code of Ethics
- Knowledge and experience in review of promotional materials involving medical devices is preferred