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

Date Posted: 8/7/2018

Job Snapshot

  • Employee Type:
    Contingent
  • Duration:
    72 weeks
  • Date Posted:
    8/7/2018
  • Job ID:
    130628
  • Pay Rate
    $20.0 - $25.87/Hour
  • Contact Name
    Volt Branch
  • Phone
    703-539-5374

Job Description

Position: Editorial Publication Assistant (7+ years)

Location: Indianapolis, IN

Status: 18-month contract

The Editorial Publication Assistant creates and maintains US regulatory registrations, creates global registrations, and provides maintenance support as needed for major markets for major markets. The purpose of this role is to prepare submission documents for submissions to regulatory agencies worldwide. Documents are organized using special electronic tools into items or, more recently, into modules. This position partners with Submission Coordinators, Regulatory Scientists, other publishing centers, and/or other contributing areas to execute the complete submission.

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 Sondeep "Sunny" Singh 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