Lilly Nonclinical Submission Coordinator-FDE in Indianapolis, Indiana
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.
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
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 ( LillyRecruitingCompliance@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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
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