Job Search Results - Biospace
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Technical Resources International Inc.
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3/15/2017
Technical Resources International Inc.
Bethesda, MD

• Reproduce simple and complex documents for submission to regulatory agencies and distribution to stakeholders. • Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents. • Maintain effective high-profile...

3/15/2017
Technical Resources International Inc.
Bethesda, MD

This position will require managing the lifecycle of investigational applications (INDs, NDAs, BLAs, IDEs, etc.) and ensuring compliance in accordance with GCPs/ICH and all applicable FDA regulations. Preparing and/or processing scientific and...

3/15/2017
Technical Resources International Inc.
Bethesda, MD

• 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...

3/15/2017
Technical Resources International Inc.
Bethesda, MD

• Overseeing and managing electronic regulatory submissions in support of active and planned investigational applications (INDs, NDAs, BLAs, IDEs, etc.) corporate-wide • Applying knowledge of electronic publishing requirements to ensure compliance...