Indiana Healthcare Jobs

Mobile Indiana Career Connect Logo

Job Information

Lilly Associate Submission Coordinator- ADME-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.

It is an exciting time to be a part of Team Lilly! Do you have experience working in a GLP environment and managing regulatory document submissions? Our Scientific Oversight team is a hardworking and diverse group looking for an individual with expertise in management of nonclinical document submissions and the fundamentals of Good Laboratory Practices (GLP). We need someone who understands the purpose, components, and outcomes of successful drug development. You will coordinate global regulatory submission activities for ADME as well as other nonclinical functions as needed. This role requires collaboration with project leaders to assign responsibilities for authoring submission tables and documents, to prepare critical chain timelines and coordinate functional responsibilities with the team’s submission coordinator. You will provide submission document support through the generation & review of Common Technical Document Tables. To enable nonclinical document submissions, you will be responsible for establishing and handling the entire submission process, ranging from timeline management and adherence to regulatory authority guidelines to editing documents and publishing for submission.

Responsibilities

Nonclinical Document Submission:

  • Serve as the Subject Matter Expert for the nonclinical document and submissions planning as well as the nonclinical electronic Common Technical Document (eCTD) content.

  • Coordinate timelines and submission activities with a variety of scientists, discovery biologists, and environmental risk assessment scientists.

  • 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.

Report Writing and Review:

  • Integrate and assemble ADME information for IND/CTD and IB documents

  • Coordinate and monitor the internal review of study data to assure compliance with study timelines.

Business Plan Objectives

  • Lead or collaborate with inter- and intra-department colleagues to accomplish objectives developed to benefit the group

Basic Qualifications

  • Bachelor’s degree in preferably in Biology, Animal Sciences, Toxicology or a related field

Additional Skills and Preferences

  • Two or more years of experience in relevant industry setting

  • Expertise in Microsoft Office

  • Excellent communication skills (written and oral)

  • Attention to detail and ability to multitask

  • Good understanding of scientific principles and design of scientific studies

  • Strong teamwork skills with internal and external partners

  • Understanding of Regulatory policies and procedures pertaining to GLP study design and reporting

Additional Information

  • This position is not permanent. It is for a fixed term position up to a maximum of 4 years.

Lilly embraces diversity and equal opportunity. We are committed to building a team with a variety of backgrounds, perspectives, and scientific skill sets.

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!

#WeAreLilly

DirectEmployers