Regulatory Specialist - Clinical Research

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POST DATE 8/31/2016
END DATE 10/23/2016

Technical Resources International Inc. Bethesda, MD

Company
Technical Resources International Inc.
Job Classification
Full Time
Company Ref #
360530
AJE Ref #
576029888
Location
Bethesda, MD
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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Responsibilities:

Managing the lifecycle of investigational applications (INDs, NDAs, BLAs, IDEs, etc.) and ensure compliance in accordance with GCPs/ICH and all applicable FDA regulations.


Preparing scientific and regulatory documents (e.g. clinical protocols, investigator s brochures, informed consent forms, annual reports, investigational new drug applications, new drug applications, regulatory correspondence, and clinical summary reports).