Scientific Writer • Global Scientific Communications Toxicology Non-clinical 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 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 Lilly's core assets. It is fundamental to Lilly to consistently and timely provide balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients throughout the entire drug development lifecycle.The purpose of the Associate- Toxicology/ Non-Clinical Submissions role is to work with cross-functional, multidisciplinary teams to lead the development of documents intended for regulatory audiences (including, but not limited to, nonclinical study reports, briefing documents, regulatory responses, Investigational New Drug Applications, and Marketing Authorization Applications).Primary Responsibilities: 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 can change over time and can include additional responsibilities not specifically described in the job description.Document Preparation, Development and Finalization/Document ManagementPlan (including organizing/preparing outlines), write (including transferring data and authoring in a templated report format), edit, review, coordinate, and complete the ADME study reports supporting nonclinical development/product registration.Ensure data are presented in a clear, complete, accurate, and concise mannerConduct effective submission/document initiation meetings to ensure nonclinical team alignment and understandingEnsure that key data, statements and conclusions are consistent across all related nonclinical documentsFormat/Publish nonclinical deliverables as per regulatory standardsProject and Stakeholder managementLead the submission process and apply effective project management skills to ensure timely completion of high-quality regulatory documentsBuild/communicate credible writing/submission project timelines for the nonclinical teamEnsure and coordinate authoring, peer/management/ regulatory reviews, quality checks for accuracyEffectively coordinate submission activities with Absorption/Distribution/Metabolism/Excretion (ADME), Toxicology (Tox)/ Pathology (Path), Pharmacokinetics (PK)/Pharmacodynamics (PD) (ATP) scientists, discovery biologists, and environmental risk assessment scientistsAnticipate and mitigate risks, to ensure document completion and deliveryEffectively communicate project status to stakeholdersExhibit flexibility in coordinating preparation of multiple document typesNonclinical Submissions CoordinationEstablish and manage nonclinical regulatory submission timing and deliverablesServe as the subject matter expert for nonclinical electronic Common Technical Document (eCTD) content, as well as for nonclinical document and submissions planningTrack progress, including document publishing, approval, and transition, to the regulatory submission publishing teamKnowledge Sharing and Skills DevelopmentMaintain and enhance knowledge of regulatory guidelinesProvide guidance to others regarding any nonclinical submission/documents related informationRecognized for technical expertise in specific document developmentNetwork with others (including other functions and regions) to identify and share best practicesContribute to process improvements, suggesting opportunities where appropriatePerform other duties as assigned by managementLilly 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 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.#WeAreLilly