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.
Manage submissions
- Plan submission workload by reviewing/monitoring RIM for planned documents for registration submissions.
- Partner with the Global Regulatory Associate and Regional Submission Associate to retrieve, publish, and submit
- Modules 1-5 reports/documents and combine files into electronic submissions (eCTD) and/or non-eCTD submissions according to the master table of contents or Content Plan for the dossier.
- Coordinate global registration activities and provide the necessary documentation to affiliates for registration of products in global countries
Submit and archive submissions
- Submit and archive submitted submissions, assuring all metadata fields are complete in RIM.
- Manage FDA Web trader account to enable submissions via electronic gateway.
- Assure all appropriate metadata fields are completed when archiving in electronic filing system (RIM).
- Assure accurate entry for future retrieval of submissions if/when requested
Build on high level of expertise in electronic publishing
- Achieve a high level of technical and practical proficiency with eCTD XPress, Adobe
- Acrobat, Submission Validation software (Lorenz), ISIToolbox.
- Successfully complete the formal training modules.
- Stay up to date on system and tool upgrades that impact publishing.
- Share technical information among staff members and apply what is learned in day-to-day work.
- Apply learning from quality review of submission work.
- Keep up to date in subject matter expert area.
Build technical and quality expertise
- Understand changes to Regulatory Guidance and Requirements and advise RDE
- Management as to their potential impact on Publishing.
- Keep current on latest quality improvement methods.
- Ensure best practices through partnership with Regulatory Quality
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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