Publishing Specialist

3 weeks ago


Bengaluru, Karnataka, India Lilly Full time

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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