Description
I have a 12 month contract Regulatory Submissions Publisher role for a Pharma based in Princeton or Rockville. Liquent experience is a MUST and I am looking for somoeone with a track record in Regulatory Submission Publishing experience. The succesful candidate will require knowledge of FDA/EMEA regulations and guidance for electronic and paper submissions.Job Responsibilities:
* Planning and publishing of new submissions following industry and regulatory standards.
* Produce paper/electronic regulatory submissions (e.g., Clinical Study Reports, INDs, annual reports, routine submissions) in accordance with U.S. FDA and global requirements, using electronic publishing tools and an EDMS system.
* Compile documents from document management system into publishing assemblies.
* Perform publishing QC and validation of routine submissions and report level publishing activities.
* Review and Prepare documents for electronic submissions by adding and ensuring that documents
contain the proper navigation (hyperlinks, bookmarks and PDF settings)
Technical Skills:
* Strong computer skills with demonstrated experience and ability in Documentum, Microsoft Office
suite (Word, Excel, Access, and PowerPoint), and the Internet
* Strong Working knowledge of Liquent Insight Publisher, Liquent eCTD Reviewer with Conformity
Checker, GlobalSubmit, Validate, GlobalSubmit Review, and ISIToolbox is required.
If you are interested, please attach an up to date CV and I will be in touch.
To find out more about Real please visit www.realstaffing.com