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Documentation Specialist II

Newark Metro Area, NJ

Post Date: 07/30/2018 Job ID: JN -072018-22160 Job Type: Scientific
Duties:Tracking and reviewing change control documentation. Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulator requirements. Must be able to work quickly with a high degree of accuracy. Must possess sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others. Experience: 3 to 6 years.
  • Knowledge and understanding of the structure and content of Regulatory submissions to FDA for both Investigational New Drug (IND) and New Drug Application (NDA)
  • Experience in using SharePoint sites (e.g. creating new folders, uploading files, granting access to users, etc.)
  • Knowledge and experience in electronic document management systems
Education:Bachelor's Degree (preferred) or equivalent experience; Associates Degree

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