Senior Director - Counsel, Manufacturing/Supply

Position Overview

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

The Senior Director - Counsel, Manufacturing/Supply will be part of the Regulatory Legal Team (RLT), which reports up through Lilly’s General Counsel and works across Lilly Legal and the Company with a highly cross-functional approach. RLT is a collaborative team of lawyers who collectively maintain the core legal expertise for the Company on regulatory law, including for clinical development and registration, manufacturing and quality, patient safety, environmental and other areas of law. RLT provides legal advice to teams and leadership across Lilly Research Laboratories and our affiliates worldwide.

Responsibilities

The primary responsibility of this position is to provide legal advice regarding regulations and strategy on drug manufacturing and supply in the U.S. and abroad. This will involve leveraging advice through collaboration with Lilly lawyers who work directly with product teams, litigation and business affiliates as well as outside counsel as required. Specific responsibilities include:

• Provide legal counsel that ensures Lilly manufacturing and quality incorporate the latest and cutting-edge interpretations of applicable laws, regulations, guidance, and harmonized standards.
• Stay current on the latest developments and trends related to manufacturing inspections and enforcement of good manufacturing practices, as well as applicable and emerging regulations and guidance documents.
• Provide legal support for global regulatory inspections, including on-site participation for key inspections as needed.
• Counsel on supply chain matters, including wholesaler/distribution issues, product recalls, illegitimate and counterfeit products.
• Draft, revise, and negotiate quality agreements.
• Counsel on matters related to controlled substances.
• Influence internal and external stakeholders regarding key policy initiatives (e.g., Drug Supply Chain and Security Act), including participation at select trade association meetings and other external activities.
• Liaise and partner with International Business Unit representatives and legal teams to ensure appropriate connections are in place to facilitate one-voice, global counseling.

Requirements

• Bachelor's and Juris Doctorate (or equivalent) Degrees.
• Licensed to practice law.
• Minimum 5-10 years of overall experience in a law firm or as an in-house lawyer in a medical device or pharmaceutical company.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.

Additional Skills/Preferences

• Prior regulatory agency experience.
• Some fluency/technical proficiency in manufacturing.
• Demonstrated leadership and effectiveness in working with senior leadership.
• Ability to triage, prioritize, and effectively counsel a high volume of inputs from a variety of sources.

Employment Type

Full time

Location Type

Information not provided

Salary

Information not provided

Company Information

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.