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Job opening for Verity Submission Manager Coordinator in Lawrenceville, NJ
Ref No.: 18-14556
Location: Lawrenceville, New Jersey
Start Date / End Date: 03/26/2018 to 09/25/2018
Job Title         :          Verity Submission Manager
Location         :          Lawrenceville, NJ
Duration         :          6+ months

The Verity Submission Manager Coordinator assists the Global Submission Manager in driving the execution of the Global Submission Plan by assisting in creation and population of Verity (Client Regulatory Information Management System) submission content plans and workflows which are used to plan and execute dossier submissions to health authorities. The Verity Submission Manager Coordinator, under the direction of the Submission Manager will assist with the build of the submission content plan and in entering appropriate submission content details including individual report details to adequately track and report dossier contents for global submissions.

Job Description:
• In collaboration with Submission Manager/Regulatory, enter Submission content plan information, either planned or retrospectively for designated regulatory submissions into the Verity Regulatory Information Management (RIM) system, including appropriate metadata for individual dossier components.
• In collaboration with Submission Manager, assist in executing workflows, issuing tasks and entry of submission information and regulatory objectives in Verity as needed.
• In collaboration with Submission Manager, responsible for QC/QA of assigned Verity information.
• Utilizes strong knowledge of ICH CTD dossier organization and or dossier publishing experience to translate a submission table of contents into a Verity submission content plan.
• Working knowledge of global regulatory practices, electronic submission guidelines and requirements.
• Must exhibit strong attention to detail, have good organization, communication, and collaboration skills, and seamless multi-tasking abilities to be able to work simultaneously on multiple projects.
• Must be comfortable working in an environment that utilizes electronic docbases, databases, publishing and computer systems (Microsoft Office, Outlook, Lync, Access, Documentum, eCTD viewers and web based applications) and be technically savvy with such systems
• Maintains a good understanding of Regulatory submission processes, regulations and other guidelines applicable to the regulatory landscape

• B.S. in a relevant field (Science or Computer Science preferred) with a minimum of 3 years of pharmaceutical industry experience.
• A minimum of one year in regulatory affairs/operations/submission management.
• Knowledge of ICH eCTD, electronic dossier publishing systems a plus.
• Understanding of submission principles is required. Level will commensurate with knowledge and experience.
• Technically savvy

Interested candidates can send their updated resumes on and you can also reach me at 973-967-3431.