Specialist-nonclinical submissions

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 39,000 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.

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 39,000 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.

Purpose:

Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly

The nonclinical submissions coordinator is responsible for establishing and managing nonclinical regulatory submission timing and deliverables, serves as the Subject Matter Expert for nonclinical electronic Common Technical Document (eCTD) content, as well as for the nonclinical document and submissions planning. Coordinate submission activities with ATP (ADME, Tox/Path, PK/PD) scientists, discovery biologists, and environmental risk assessment scientists.

Establishes and adheres to submission timelines and track progress including document publishing, approval, and transition to the regulatory submission publishing team. Review, format, and edit documents, as appropriate, for submissions

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Minimum Qualification Requirements:

•Bachelor’s degree in a scientific, biology, toxicology, health, communications, public health related field

•Strong communication and interpersonal skills.  

Additional Skill Sets:

Experience writing scientific publications.

Understanding drug development in the nonclinical space

Experience in toxicology is preferred

Experience:

2.5-4 years of experience is preferred

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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 39,000 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.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.