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Electronic Publishing Specialist in Biologics Consulting Group

Salary Range: Between 3,000 and 5,000 US$ per month

Job Published on: February 24th, 2021

Available to applicants based in Country(ies): United States of America (USA)

Important skills: BLA, eCTD, IND, Master file, NDA

Years of Experience: 2+

Biologics Consulting Group, Inc. seeks to hire a full-time electronic publishing associate with experience publishing electronic IND, Master File, BLA, and NDA submissions.

This is a remote position. The Electronic Publishing Associate will be able to connect remotely to the Biologics Consulting Alexandria, Virginia office for work.

Major Duties and Responsibilities:

  • Convert source documents in various formats to FDA guidance-compliant PDF documents
  • Bookmark and hyperlink PDF documents per FDA specifications
  • Compile PDF documents into eCTD-formatted submissions
  • Validate eCTD applications according to FDA specifications
  • Detailed tracking of project progress
  • Audit of submissions for completeness, bookmark/hyperlink accuracy, correct document placement, etc.
  • Submission of applications and sequences through the FDA Electronic Submissions Gateway
  • Write proposals for publishing projects

Qualifications:

  • College degree in relevant discipline preferred
  • experience with multiple tools/plug-ins used for publishing FDA guidance compliant PDF documents (e.g. ISIToolbox, a-Pulse)
  • experience with eCTD publishing software/Validation tools (ARIM, eCTD Manager, docuBridge, etc.)
  • familiarity with documents normally included in FDA submissions
  • familiarity with all FDA electronic submissions guidance documents
  • ability to communicate clearly with clients regarding ongoing projects
  • attention to detail
  • ability to work on multiple projects simultaneously while maintaining deadlines
  • ability to work on projects involving large numbers of documents
  • requires minimal instructions on routine work and new assignments
  • comfortable working in a team environment

Interested? Apply now!


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