Senior Counsel, Research

Medical device company seeks Senior Counsel, Research. The Senior Counsel, Research is primarily responsible for structuring and negotiating research arrangements with key research sites and participating in the company research review processes. These research arrangements may include a wide range of the company’s medical device equipment and software. His/her tasks would also include structuring contracts with research consortia and advising on related funding arrangements.

Essential Responsibilities

• Working with the research, technology/engineering, product P&L, and intellectual property teams as a business partner to review and formalize research opportunities, and to resolve legal issues that arise in ongoing research arrangements in order to drive business product development forward

• Drafting, reviewing, negotiating, and assisting in managing strategic research agreements

• Advising the business on Good Clinical Practices (GCP), Fraud and Abuse, Regulatory, Privacy, Advertising/Promotional matters and other legal issues that arise in the research context

• Participating in the company research approval processes

• Providing regulatory and compliance advice in conjunction with the Regulatory, Finance, and Compliance specialist areas in the company

• Develop and deliver research training and associated resource materials as needed

• Consult with Medical Affairs and Clinical Affairs on adverse event evaluation and reporting

• Managing outside counsel when brought in to assist

• Applying combined business and legal judgment to proposed research arrangements, ongoing research relationships and other issues requiring legal or compliance attention

Quality Specific Goals:

• Aware of and comply with the company Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

• Complete all planned Quality & Compliance training within the defined deadlines

• Identify and report any quality or compliance concerns and take immediate corrective action as required

• JD (or equivalent) with active bar membership

• 8 years of legal work experience, with at least 4 years of health care experience at a large law firm, corporate legal department, government agency, or research organization, including previous experience drafting and negotiating research agreements

• Well-versed in GCP principles and research regulations with some experience with enforcing research compliance

• Previous relevant experience with IP issues as related to research projects

• Experience in, or advising the Healthcare industry, and previous exposure to medical industry regulations (FDA, Medicare/Medicaid Anti-Kickback, Privacy)

• Previous experience in identifying and resolving legal issues quickly and effectively and ability to make challenging risk decisions

• Previous experience prioritizing conflicting demands from multiple business clients in an extremely fast paced environment

Desired Characteristics

• Experience working on global research projects

• Experience working with contract research organizations

• Demonstrated experience providing legal advice in a highly regulated environment

• Experience or familiarity working with academic research centers