Electronic Submission Specialist
Edison-New Brunswick Metro Area, NJ
Responsibilities will include, but are not limited to, the following:
1. Support 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. Responsible for the 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. Responsible for maintenance of all Regulatory and Health Authority submission archiving within specified time frames.
4. Verification of regulated electronic documents via workflows within company s electronic document management system.
5. Adherence to required submission timelines, health authority publishing specifications, and internal working practices.
6. Liaise with functional source areas (clinical, nonclinical, cmc, regulatory) to ensure documents are compliant with authoring style guide.
- Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.
- Close interaction with authoring community to track availability of deliverables.
7. Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
8. Other responsibilities related to the above within company as a whole, as assigned.
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)
Technical knowledge of electronic publishing systems/document management systems and software
BA/BS Degree or equivalent experience
Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic
Proficiency with MS-Office Suite and Adobe Acrobat applications
Knowledge of health authority procedures/guidance s regarding electronic submissions
Ability to balance multiple tasks to meet priorities and timelines
Self-starter with superior time management skills, and ability to work independently or in teams
Strong attention to detail