Editorial Publication Assistant (7+ years) in Indianapolis, IN at Volt

Date Posted: 8/7/2018

Job Snapshot

Job Description

Position: Editorial Publication Assistant (7+ years)

Location: Indianapolis, IN

Status: 18-month contract

This Fortune 500 Company discovers and brings life-changing medicines to those who need them, improves the understanding and management of disease, and gives back to communities through philanthropy and volunteerism. Greater than 90% of workers rate their contract assignment as above average or excellent.

Responsibilities:

  • Responsible for creating links and bookmarks to aid the regulatory agencies in their reviews of the submission
  • Work closely with regulatory and contributing teams to understand the specific requirements as well as the applicable submission regulations and guidelines
  • Planning submission workload by reviewing/ monitoring the CRR Calendar for planned documents for registration submissions
  • Receive process, publish, and submit Module 1, 2, and/or 5 reports/documents from contributing areas of LRL and will combine these files into electronic submissions (eCTD) according to the master table of contents for the dossier
  • Creates different dossiers for Europe, the U.S. and sometimes Canada or other supported worldwide markets.
  • Receive, process, and publish CRFs and datasets required for regulatory submissions
  • Receive, process, publish, and submit U.S. FDA required post-Marketing supplements and amendments (IsRA).
  • Responsible (R) for managing their assigned molecule for routine submissions
  • Manage FDA Webtrader account to enable submissions via electronic gateway
  • Assure all appropriate metadata fields are completed when archiving in electronic filing system (eFiles)
  • Update Document status to manage workload and provide information on specific documents’ status as it pertains to any specific submission
  • Track and report on the progress of document and submission preparation
  • Maintain and update the submission table of contents
  • Maintain and create document and submission calendar entries
  • Ensure compliance with FDA/Regulatory Agencies regulations and Lilly policies and procedures
  • Ensure quality assurance of submission documents and materials
  • Comply promptly and thoroughly with all investigation or audit requests
  • Submit and Archive submitted Registrations to central electronic filing system (eFiles)

Required Qualifications:

  • 7+ years of experience in a regulatory setting and/or pharmaceutical industry
  • Experience using eCTD express, Adobe Acrobat and MS Office
  • High School diploma or equivalent
  • Effective communication/interpersonal skills
  • The individual must be able to maintain the security of confidential information

Preferred Experience:

  • Experience with NDAs/INDs
  • Experience with international regulatory submissions

Please apply to position or contact Matt Haltom at (317) 685-2200 for any questions and more details regarding this position.

Volt has been serving some of the nation's strongest companies for over 60 years. As a Volt employee, you can expect the highest level of on-site support. We have a long-standing tradition of developing lasting and mutually beneficial relationships with its employees.

Volt is an Equal Opportunity Employer