Description
Regulatory Submission Publisher/eCTD/eCTDXpress/ISI Toolbolx/ ISI publisher/Documentum/IND/NDA/BLA.I have a 12 month contract requirement for 5 Regulatory Submission Publishers for a market leading Pharma based in Marlyland.
I am looking for someone with 3-5 years experience in filings of INDs, NDAs, BLAs preferably in eCTD format or CTD format. My client uses Liquent products at the moment but will be moving to EctdXpress within the duration of the contract.
Extensive experience in both Electronic Submissions (US ectd, centralized submissions, MPD submissions) and Paper Submissions will be required.
Tools Required: Liquent Insight Publisher, Liquent Core Dossier, eCTDXpress, ISI Toolbox, ISI Publisher, Documentum.
Some remote work is an option, if you are interested, please attach an up to date CV and I will be in touch.