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
- 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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