Electronic Submission Specialist
A global biopharmaceutical company is seeking to hire an Electronic Submissions Specialist for a 12-month contract for their Summit, NJ headquarters.
The Electronic Submission Specialist will be responsible for: 1) supporting the Global Regulatory Operations Leads in the coordination, preparation, and submission of all INDS/NDAs/MAAs & 510Ks and life cycle management in eCTD as well as paper and NeeS formats. 2) Creation, assembly, publishing, and verification of both major and routine regulatory dossier submissions, including IND safety reports, DSUR, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Responses, etc. 3) Maintaining all Regulatory and Health Authority submission archiving within specified time frames. 4) Verification of regulated electronic documents via workflows within the company's electronic document management system. 5) Adhers to required submission timelines, health authority publishing specifications, and internal working practices.
Location: Summit, New Jersey (100% office-based)
Duration: 12-month contract
Compensation: $38-42 per hour
- Must have 2 yrs. pharmaceutical industry publishing experience required (MUST specifically be in Regulatory Operations).
- Experience with compiling eCTD, validating, and verification of eCTD submissions in a publishing tool (eg, eCTDXPress, eCTDManager, ViewPoint, etc)
- Needs to have technical knowledge of electronic publishing systems/document management systems and software.
- Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic is required.
- Education: BA/BS Degree or equivalent experience
- Must be proficient with MS-Office Suite and Adobe Acrobat applications
Sthree US is acting as an Employment Business in relation to this vacancy.