Skip to main content
Search Jobs

Nonclinical Submission Coordinator-FDE

Indianapolis, Indiana

Apply NowApply Later
Req ID R-8012 Title Nonclinical Submission Coordinator-FDE City Indianapolis State / Province Indiana Country United States

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.

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. You can be a part of this important process!

The Toxicology group is looking for a nonclinical submissions coordinator to contribute to the progress of Lilly's research. The role is responsible for establishing and managing nonclinical regulatory submission timing and deliverables. You will serve as the Subject Matter Expert for nonclinical documents and submissions planning as well as coordinating all submission activities with a variety of scientists, discovery biologists, and environmental risk assessment scientists.

Additional Details

  • Serve as the SME for nonclinical electronic Common Technical Document (eCTD) content.
  • Coordinate timelines and submission activities with pertinent collaborators.
  • Ensure adherence to company and regulatory guidelines for document submissions.
  • Assist with regulatory responses.
  • Manage and track progress of submission timelines.
  • Review, format, edit and publish documents

Minimum Qualification Requirements:

  • Bachelor’s degree in biology, toxicology, animal health or related field

Additional Skills/preferences:

  • At least 2 years of relevant experience preferred
  • Experience writing scientific papers/ publications is preferred
  • Expertise in Microsoft Office
  • Overall understanding of nonclinical and clinical drug development
  • Strong communication and interpersonal skills

This position is not permanent. It is for a fixed duration of two years with potential to extend annually for up to four years.

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 is an EEO/Affirmative Action Employer and 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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-8012.

Lilly is an EEO/Affirmative Action Employer and 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.

Apply NowApply Later

About Science

Our scientists and researchers are developing the breakthrough medicines of tomorrow. Join us and become a creative innovator and thinker who can improve the lives of millions.

Recruiting Events

We’d love to meet you to discuss career opportunities. Check our calendar now to see when we’ll be in your area.

View All Events

Stay Connected

Job Alerts

By signing up for job alerts, you’ll be the first to learn about opportunities that could be a great fit for you via periodic email updates.

Sign Up

Join Our Talent Community

Share a bit about yourself, such as the career area you are interested in. We will then reach out to you when the perfect position is available!

Sign Up

Sign Up

Areas of InterestSearch for a category, location, or category/location pair, select a term from the suggestions, and click "Add.”