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Documentation Specialist

Newark Metro Area, NJ

Posted: 09/18/2018 Job Type: Scientific Job Number: JN -092018-22578
Description:
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.

Skills: Applicant should be familiar with INDs, NDAs, eCTD Submissions, Health Authority Communications, Veeva Vault

Education: 4 year degree
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