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Regulatory Operations Specialist Jobs

Bridgewater, New Jersey
<p>Job Title: Regulatory Operations SpecialistJob Location: Bridgewater, NJJob Duration: 7 monthsPosition DescriptionTitle: REGULATORY OPERATIONS SPECIALISTThe NDA/BLA Regulatory Specialist is responsible for performance of the medical services portion of the NDA annual report. In particular, the NDA AR Project Manager is responsible for overseeing and managing the timely assembly of the Clinical Data Template for their assigned products. The Project Manager is responsible for ensuring the process is followed in compliance with all appropriate SOPs.The individual will be expected to quickly gain familiarity with internal clinical databases such as Crystal, PRISMA, CTMS, and to gather all of the relevant information to assemble the Clinical Data Template. The individual may also act as quality control viewer for CDTs prepared by other individuals.Knowledge and Skills: Strong attention to detail is a MUST Project management and organizational skills Decision making and problem solving skills Ability to work autonomously Working knowledge or clinical development, FDA regulations and ICH/GCP guidelines Understanding of database concepts Knowledge of industry standards and practices preferred Excellent interpersonal and communication skills, including medical terminology Strong organizational and time management skillsMinimum Qualifications:1. Bachelor Degree in business or science area with 3+ years pharma/biotech industry experience in clinical research or medical affairs.2. Track record of successfully managing multiple complex projects from start to completion.This role will be based in Bridgewater, NJ.</p>
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