Senior Director, Counsel, Diagnostics & Medical Devices

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer strategic and solution-focused guidance to the Neuroscience Business Unit as well as other Lilly business units regarding diagnostic and device issues associated with commercial strategy.

• Advise marketing, medical affairs, and related teams on legal commercial matters concerning diagnostics, including FDA labeling and advertising requirements, the Anti-Kickback Statute and its safe harbors, the False Claims Act, antitrust, unfair competition law, consumer protection, data rights and privacy, FTC commercial law, and business transactions.

• Provide legal advice and training on FDA labeling and promotional issues for diagnostic products, medical devices, and pharmaceuticals.

• Deliver counsel on fraud and abuse, promotional activities, and antitrust matters related to diagnostics and devices.

• Collaborate with sales and marketing teams on patient support and consumer programs related to devices or diagnostics.

• Educate business partners on the legal ramifications of proposed marketing strategies.

• Advise on the legal considerations of interactions with third parties, including diagnostics firms and software/digital health companies.

• Provide counsel on sponsored testing initiatives.

• Participate as a key member of leadership teams focused on brand and product strategies related to diagnostics and devices.

• Work in partnership with legal colleagues, business units, and affiliates.

⛳️ Requirements

• Bachelor's degree and Juris Doctor (JD).

• Licensed to practice law in at least one of the 50 States.

• A minimum of 7 years of pertinent legal experience.

• Experience working as part of a law firm recognized nationally for its medical devices and in vitro diagnostics practice, in-house at a medical device, laboratory, or diagnostics company law department, in-house in a pharmaceutical or biotechnology company's law department, or a combination of these experiences.

• Qualified candidates must be authorized to work full-time in the United States.

• Extensive knowledge and understanding of FDA laws and regulations related to diagnostics and medical devices, including the Medical Device Amendments of 1976 to the FDCA, CLIA, and state laws.

• Familiarity with device and pharmaceutical marketing laws and regulations.

• Experience handling fraud and abuse, promotional, and antitrust issues.

• Proficient in evaluating sponsored testing programs for compliance.

• Skilled in reviewing scientific communications and applying principles for conveying truthful and non-misleading scientific information.

• Capable of managing multiple priorities in a dynamic and fast-paced environment.

• Ability to assess and assist business colleagues in managing risks within a highly regulated setting.

• Strong judgment and issue-spotting capabilities.

• Excellent interpersonal skills with the ability to collaborate effectively with others.

• Commitment to teamwork and collaboration.

• Outstanding oral and written communication skills, with the ability to present complex information clearly and concisely to influence management at all levels.

• Proficiency in technology and eagerness to implement technological solutions to streamline processes and enhance efficiency in delivering legal services.

🏝️ Benefits

• Company bonus, which is partially based on individual and company performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• Flexible benefits, including healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Various time-off and leave of absence benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.