Electronic Publishing Specialist
The e-publishing specialist, under direction of senior Regulatory Writing staff, is responsible for contributing to project delivery, dossier quality, efficient dossier processes and rapid response to agency questions.
This position is responsible for the assembly and publishing of all documents to be submitted to external regulatory authorities to agreed standards and contributing to the definition of document standards.
The specialist will focus on publishing day to day submissions as well as assisting with other submission projects.
This position plays a key role in terms of establishing and maintaining adequate infrastructure and processes to support regulatory submissions, supporting registration data requirements, and maintaining schedules for key regulatory submissions. All submissions ( INDs, eCTDs, NDAs, etc) are associated with significant business impact; ensuring adequate technical oversight including late-stage publishing/troubleshooting is critical.
Collaboration with the Global Publishers, Publishing Managers, and Regulatory Product Mangers regularly providing up to date status reports and reporting of issues in a timely manner. The submission specialist will work closely to understand current workload, and ensure support to other publishers. The duties performed in this position consist of the following tasks:
Create and assist with Virtual Document creation.
Remediate pdf documents to be submission ready.
Publish submissions (using eCTD Manager or plug-ins).
QC outputs to be submitted (validate if necessary).
Submit via the corresponding Gateway (ESG, Webtrader, EMA Gateway, CESP, …) if required
Store submissions and acknowledgements in Document end Management System.
Participate in other Regulatory Writing activities as required (e.g. Software upgrade testing, Document reviews etc.)
Ensure effective and standardized use and functionality of the regulatory submission assembly and publishing systems, processes and tools, and the integrity of the information (QC checks, training etc)
Perform Functional Administrator duties for RA eDoc systems, such as eCTD and eBLA, as necessary. Create folders on network file shares. Export or Import files, create Virtual Documents, add users and assign to groups.
Working knowledge of IND/CTA, eNDA/eBLA, CTD submissions, XML, document management systems, regulatory databases, electronic labeling standards (PIM, SPL).
Successful submission dossier experience in a regulated environment.
Experience in Document and Records Management system and electronic publishing.
Experience with ICH, US, and EU Regulatory Requirements on all publishing formats (paper, NeeS, and eCTD).
Experience with EXTEDO eCTD management and/or Veeva RIM software a plus.
Minimum BS, Information and Database Management Systems, or Health Information Management with 1-3 years relevant regulatory affairs experience.
Website : http://www.oraclinical.com/