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Regulatory Affairs Publisher - Bridgewater, NJ
Ref No.: 18-01451
Location: Bridgewater, New Jersey
 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:
  • 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.
Experience:
  • 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
Qualifications:
  • Diploma/ Bachelor degree in Pharmacy, Life-Science