Regulatory Publishing Specialist
3 weeks ago
We're seeking a highly skilled Regulatory Publishing Specialist to join our team at Lilly.
Key Responsibilities:
• Manage submissions, preparing cover letters and forms for regional 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 and combine files into electronic submissions (eCTD).
Requirements:
• Achieve a high level of technical and practical proficiency with eCTD XPress, Adobe Acrobat, Submission Validation software (Lorenz), and ISIToolbox.
• Stay up to date on system and tool upgrades that impact publishing.
What We Offer:
Lilly is an equal opportunity employer and welcomes applications from diverse candidates. We offer a dynamic work environment, opportunities for growth and development, and a competitive compensation package.
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