Publishing Specialist
3 weeks ago
We're seeking a Publishing Specialist to manage eCTD submissions and maintain regulatory compliance.
Main Responsibilities:
- Prepare submission cover letters and forms for review and approval.
- Plan submission workload by reviewing the RDE RIM or Share Point Calendar for planned documents.
- Partner with the Regulatory Associate to retrieve, publish, and submit Modules 1-5 reports/documents.
- Coordinate global registration activities and provide necessary documentation to affiliates.
- Submit and archive registrations, incoming correspondence, and Records of Contact with Regulators.
Requirements:
- Achieve a high level of technical and practical proficiency with eCTD XPress, Adobe Acrobat, and Submission Validation software.
- Successfully complete formal training modules.
- Stay up to date on system and tool upgrades that impact publishing.
Lilly is an Equal Opportunity Employer.
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