Regulatory Affairs Publisher - Bridgewater, NJ - Georgia IT Inc.
Bridgewater, NJ
About the Job
Title : Regulatory Affairs Publisher
Location : Bridgewater, NJ
Duration : Full Time
No Visa Sponsorship available for this job. No third-party agencies Corp To Corp
Job description:
Location : Bridgewater, NJ
Duration : Full Time
No Visa Sponsorship available for this job. No third-party agencies Corp To Corp
Job description:
- Responsible for global regulatory submission / dossier publisher day-to-day activities and deliverables. Regulatory Publishing involves preparing the Clinical Documents (written by the Med. Writers) for submission through eCTD gateway
- Experience with electronic document management systems, submission publishing tools, knowledge of documents publishing/document management including, Adobe Acrobat.
- Compilation of regulatory documents, Maintaining Regulatory documents as per the procedure in client repository.
- Performing high level of formatting in both word and PDF files using the client provided software.
- Creating Bookmarks, hyperlinks, file Optimization etc. are some of the key activities.
- Perform technical quality control (electronic functionality, adherence to internal and external document standards) of dossier documents.
- To interact with scientific personnel and Project Team Representatives in the preparation, QC and publishing of nonclinical and clinical study reports and regulatory documents.
- Provide input and advice to project and trial teams on "submission readiness” requirements for document components.
- Supporting the client in aligning the process maps/SOPs/WI as per recent updates.
- 2-4 years of experience in the pharmaceutical industry, with relevant experience in electronic submission publishing, dossier management and dispatch of global drug dossiers (North America, Caribbean, Latin America, etc.).
- Expert in HA submission publishing requirements globally.
- Strong knowledge of regulatory processes and related tools (document management, publishing, etc.
- Excellent verbal and written communication skills.
- Demonstrated ability to be innovative and a creative thinker • High level of organizational
- Diploma/ Bachelor degree in Pharmacy, Life-Science
Source : Georgia IT Inc.