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Electronic Publishing Specialist
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, book
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