Doc Review Spec I/ii - Bengaluru, India - Thermo Fisher Scientific

Thermo Fisher Scientific

Verified Company

Bengaluru, India

3 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

The Senior Document Review Specialist is responsible for the thorough review of documents created within or outside of PPD in order to ensure quality of a standard that meets or exceeds client's expectations.

These documents include, but are not limited to, regulatory submissions (sections of NDAs, BLAs, PLAs, INDs, CTDs), integrated clinical study reports, serious adverse advent narratives, study protocols, case report forms, and publications (manuscripts, posters, abstracts).

The Senior Document Review Specialist is responsible for ensuring the integrity of the data presented by conducting a timely and cost-effective review of diverse scope against client, PPD, and regulatory requirements and specifications.

The Senior Document Review Specialist brings to the review a comprehensive knowledge of clinical research, PPD procedures, English grammar, diverse therapeutic areas, experimental design, and regulatory requirements.