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Eli Lilly and Company · 1 day ago

Associate Vice President, Assistant General Counsel, Regulatory Legal Team – Americas Region

Indianapolis, IN

Full-time

Hybrid

Director/Executive

$230K/yr - $337K/yr

7+ years exp

Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. They are seeking an Associate Vice President, Assistant General Counsel to provide legal advice on regulations and strategy related to drug, medical device, and diagnostic matters for the US and other Americas Region countries.

BiotechnologyHealth CareMedicalPharmaceutical

No H1B

Responsibilities

Provide legal counsel on matters related to drug, medical device and diagnostic clinical programs and regulatory submissions in the US and other Americas Region countries

Provide legal counsel that ensures Lilly development programs incorporate the latest and cutting-edge interpretations of applicable laws, regulations, guidance, and harmonized standards

Stay current on the latest drug, medical device and diagnostics laws, regulations and guidance documents, including recently passed or implemented and emerging laws and regulations

Influence internal and external stakeholders regarding key policy initiatives including participation at select trade association meetings and other external activities

Provide legal support to the Global Regulatory Strategy Teams and Americas Regional Regulatory Team and related policy groups regarding policy and legislative issues related to drugs, medical devices and diagnostics

Maintain and improve an understanding of the clinical and regulatory submissions process and regulatory structures in the US and other Americas Region countries

Liaise and partner with International Business Unit representatives and legal teams to ensure appropriate connections are in place to facilitate one-voice counseling

Qualification

Pharmaceutical lawRegulatory submissionsMedical device regulationsLegal counselLeadership skillsInterpersonal skillsWritten communicationVerbal communicationAttention to detail

Required

Bachelor's and Juris Doctorate Degrees

Licensed to practice law in at least one of fifty states

Demonstrated expertise in the law and regulations pertaining to pharmaceuticals, medical devices and diagnostics in the US and at least one additional key market in the Americas Region

Minimum of 5-7 years' experience as a lawyer in a law firm, or as an in-house lawyer in a pharmaceutical company, where candidate's primary focus was pharmaceutical law

Minimum 7-10 years of overall experience in a law firm or as an in-house lawyer in a device or pharmaceutical company

Qualified candidates 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

Preferred

Experience counseling on drug regulatory matters in Canada, Brazil and Mexico

Prior regulatory agency experience

Ability to navigate across different country/cultural contexts

Demonstrated leadership and effectiveness in working with senior leadership

Highly motivated and collaborative partner with strong interpersonal skills and the ability to work effectively with team members, other lawyers, and members of management across all levels of the Company

Good judgment and meticulous level of attention to detail

Excellent written and verbal communication skills with an ability to influence others

Demonstrated ability to appropriately handle highly confidential information

Demonstrated dedication to expand knowledge and adapt to a changing environment

Candidates based in or willing to relocate to Indianapolis, IN highly advantageous