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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$225,000 - $330,000

Organization Overview:

This position 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 maintains core legal expertise on clinical development, registration and regulatory matters and works together with other legal teams to provide comprehensive and strategic solutions for the business. RLT also provides regulatory law advice to Global Regulatory Affairs, Manufacturing & Quality, Global Patient Safety, Clinical Development and other functions and teams.

Responsibilities:

The primary responsibility of this position is to provide legal advice regarding regulations and strategy on drug, medical device (software and hardware) and diagnostic matters for the Asia-Pacific Region (China, Japan, Korea, Australia, Taiwan and other jurisdictions). This will involve leveraging advice through collaboration with Lilly lawyers who work directly with product teams and business affiliates as well as outside counsel as required.

Provide legal counsel on matters related to drug, medical device and diagnostic clinical programs and regulatory submissions.
Provide legal counsel that ensures Lilly clinical 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 Asia-Pacific Regional Regulatory Team and related policy groups regarding Asia-Pacific country 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 Asia-Pacific countries.
Liaise and partner with International Business Unit representatives and legal teams to ensure appropriate connections are in place to facilitate one-voice counseling

Basic Requirements:

Bachelor’s and Juris Doctorate (or equivalent) Degrees
Licensed to practice law
Demonstrated expertise in the law and regulations pertaining to pharmaceuticals, medical devices and diagnostics in China, Japan and other key markets in the Asia-Pacific 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 legally authorized to be employed in their country of 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.

Lilly RTP is looking for eager individuals excited to get their start in pharmaceutical manufacturing. Lilly is partnering with local community colleges (Wake Tech and Durham Tech) and the NC Life Sciences Apprenticeship Consortium to hire 2 Operations Apprentices into our Formulation and Filling areas at our new state-of-the-art highly automated facility in Durham, NC. The Operations Apprentice will work as a Lilly employee while simultaneously continuing their education at Wake or Durham Tech.

This is a one-year long apprenticeship with the opportunity to be converted to an Operator/Process Technician once all apprenticeship requirements are met. These requirements include completing 3 community college courses (General Chemistry I, General Biology I, and Intro to PLC) on top of working onsite at Lilly as an apprentice. The cost of the courses and educational materials will be covered in the form of a signing bonus upfront at the start of the program.

The Operations Apprentice will perform and support production activities on a state-of-the-art Prefilled Syringe Line, utilizing isolator technology, as well as supporting site operational goals. This role includes the opportunity to grow into a subject matter expert for the filling, formulation, or manufacturing support equipment/process with the potential for development over time.

This role will be responsible for the safe operation of highly automated equipment used to fill syringes. The Operations Apprentice is expected to model current Good Manufacturing Practices and ensure compliance with all safety standards. They will support other operators in identification of opportunities for operational improvement.

Key Objectives

Adhere to RTP Plant safety policies and procedures, contribute to a safe work environment.
Adhere to standard operating procedures and current Good Manufacturing Practices to ensure quality of product.
Support leadership and operators on manufacturing floor by ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
Proactively monitor documentation and product quality, properly documenting all activities and reporting issues to supervision.
Key support for leadership during troubleshooting, functions as reliable point of contact for issue escalation on the shop floor
Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.

Basic Requirements:

High School Diploma/GED
Holds a BioWork Certification through a local community college
Be able to work 12-hour shifts on a 2-2-3 rotation
Be able to complete the ongoing education requirements of the apprenticeship (General Chemistry I, General Biology I, and Intro to PLC)

Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$22/hr

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

Similar Opportunities