Keywords
Document Management Systems
Microsoft Visio
Microsoft SharePoint
Extensible Markup Language (XML)
Biology
Clinical Works
Clinical Trials
Electronic Common Technical Document
Electronics
Pharmaceuticals
Skills
EVMPD, eCTD, Electronic document management system, Electronic Submissions, Regulatory Submissions, Regulatory Affairs, ICH guidelines, Document Management, Regulatory Requirements, EMEA, FDA, Microsoft Office, XML, SharePoint, Microsoft visio, Visio, Lifesciences, Document publishing, Adobe Professional, ISI Toolbox, Pharmaceutics, Sop, Quality Assurance, Clinical Trial registration
Project history
Clinical Publisher and Trial Registration Administrator
09.2013 - today
Freyr Inc
Regulatory submissions associate
06.2012 - 08.2013
Providing guidelines to the technical team involved in the development of Regulatory submission tools and quality testing of the developed tools.
Managing the Electronic submissions like EVMPD.
Creating packages from Freyr EVMPD tool and uploading it to Eudraviglance database and receiving the acknowledgements.
Operating the EV WEB tool, running Queries and extracting the Excel reports from EV WEB.
Knowledge in NEES, eCTD submission.
Document publishing using ISI tool box and adobe.
Handling the Document Management System.
Preparing the documents on Drug registration process in different countries.
Information Technology and Services
51-200 employees
09.2013 - today
Freyr Inc
Regulatory submissions associate
06.2012 - 08.2013
Providing guidelines to the technical team involved in the development of Regulatory submission tools and quality testing of the developed tools.
Managing the Electronic submissions like EVMPD.
Creating packages from Freyr EVMPD tool and uploading it to Eudraviglance database and receiving the acknowledgements.
Operating the EV WEB tool, running Queries and extracting the Excel reports from EV WEB.
Knowledge in NEES, eCTD submission.
Document publishing using ISI tool box and adobe.
Handling the Document Management System.
Preparing the documents on Drug registration process in different countries.
Information Technology and Services
51-200 employees
Local Availability
Only available in these countries:
India
I have separate work station at home, comfortable for the work and discussions/meetings.
