Senior Director, Counsel, Diagnostics & Medical Devices

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

📋 Description

• Deliver strategic and solutions-focused legal advice to the Neuroscience Business Unit as well as other Lilly business units regarding diagnostic and device-related commercial strategies.

• Provide guidance to marketing, medical affairs, and associated teams on FDA labeling and advertising, Anti-Kickback Statute safe harbors, the False Claims Act, antitrust laws, unfair competition, consumer protection, data rights and privacy, FTC commercial law, and business transactions.

• Offer legal counsel and education on FDA labeling and promotional issues concerning diagnostic products, medical devices, and pharmaceuticals.

• Advise on fraud and abuse, promotional, and antitrust matters across various business units.

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

• Inform business partners about the legal ramifications of proposed marketing strategies.

• Provide advice concerning interactions with third parties, including diagnostics and software/digital health companies.

• Offer counsel on sponsored testing initiatives.

• Act as a core member of leadership teams responsible for brand and product strategies related to diagnostics and devices.

• Collaborate with legal peers, business units, and affiliates.

• Travel approximately 10% within the United States and potentially internationally.

⛳️ Requirements

• A Bachelor's degree and a JD.

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

• A minimum of 7 years of relevant legal experience.

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

• Authorized to work in the United States on a full-time basis.

• Extensive knowledge 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.

• Understanding of marketing laws and regulations for devices and pharmaceuticals as practiced by innovative, multinational companies.

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

• Experience in evaluating sponsored testing programs for compliance.

• Experience in assessing scientific communications and ensuring truthful and non-misleading scientific information.

• Capability to manage multiple priorities in a dynamic and fast-paced environment.

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

• Strong judgment and ability to identify issues.

• Excellent interpersonal skills with a knack for collaboration.

• Commitment to teamwork and cooperative efforts.

• Exceptional oral and written communication abilities.

• Proficient in presenting complex information clearly and concisely to influence all levels of management.

• Fluency in technology and enthusiasm for utilizing technological solutions to enhance legal service delivery.

• Work authorization or visa sponsorship will not be provided.

🏝️ Benefits

• Company bonus based partly on company and individual performance.

• Company-sponsored 401(k).

• Pension plan.

• Vacation benefits.

• Medical coverage.

• Dental coverage.

• Vision coverage.

• Prescription drug benefits.

• Healthcare flexible spending accounts.

• Dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being programs.

• Employee assistance program.

• Fitness benefits.

• Employee clubs and activities.

• Equal opportunity and disability accommodation support.