Scientific Writer - Toxicology and Non-Clinical Regulatory Submissions

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 Management

• Plan (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 manner
• Conduct effective submission/document initiation meetings to ensure nonclinical team alignment and understanding
• Ensure that key data, statements and conclusions are consistent across all related nonclinical documents
• Format/Publish nonclinical deliverables as per regulatory standards

Project and Stakeholder management

• Lead the submission process and apply effective project management skills to ensure timely completion of high-quality regulatory documents
• Build/communicate credible writing/submission project timelines for the nonclinical team
• Ensure and coordinate authoring, peer/management/ regulatory reviews, quality checks for accuracy
• Effectively 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 scientists
• Anticipate and mitigate risks, to ensure document completion and delivery
• Effectively communicate project status to stakeholders
• Exhibit flexibility in coordinating preparation of multiple document types

Nonclinical Submissions Coordination

• Establish and manage nonclinical regulatory submission timing and deliverables
• Serve as the subject matter expert for nonclinical electronic Common Technical Document (eCTD) content, as well as for nonclinical document and submissions planning

• Track progress, including document publishing, approval, and transition, to the regulatory submission publishing team

Knowledge Sharing and Skills Development

• Maintain and enhance knowledge of regulatory guidelines
• Provide guidance to others regarding any nonclinical submission/documents related information
• Recognized for technical expertise in specific document development
• Network with others (including other functions and regions) to identify and share best practices
• Contribute to process improvements, suggesting opportunities where appropriate
• Perform other duties as assigned by management

Lilly 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.

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Experience Level

Senior Level