Senior Regulatory Publisher Jobs San Francisco Bay Area
Senior Regulatory Publisher
A biotechnology company in the San Francisco bay area is looking for a Senior Regulatory Publisher to join their team. You will be responsible for submission ready structure in CTD/eCTD format for all Regulatory submissions to the FDA.
Regulatory Publisher Responsibilities may include:
*Using technical expertise for leading e-CTD submissions
*Creating hyperlinks/cross-references/bookmarks
*Troubleshooting document issues with Adobe Acrobat MSWord
*Managing all technical aspects for assigned submissions and status updates to concerned parties
*Collaborating with scientific personnel for planning, preparation, publishing, and quality control checks of submissions
*Fielding publishing/processing questions from other business units
*Maintaining expert knowledge of internal and external publishing standards
*Other duties as required/assigned
Senior Regulatory Publisher Qualifications:
*Extensive knowledge of Acrobat Professional and Microsoft Office applications
*3+ years of Regulatory Publishing/Operations experience
*Prior expertise with electronic publishing systems
*Knowledge of FDA Requirements for eCTD submissions
*InSight Publisher experience a plus
*Validation experience a plus
If you would like to apply to this position, please reply to this advertisement ASAP to be considered as the client is looking to identify a candidate immediately