Document Review Spec I

2 days ago

Bengaluru, India PPD Full time

**JOB DESCRIPTION**:

- The 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 event narratives, study protocols, and publications (manuscripts, posters, abstracts). The 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 Document Review Specialist brings to the review knowledge of clinical research, PPD procedures, English grammar, medicine, experimental design, and regulatory requirements.
- **Job Qualification**:
**Diversity Statement**:

- PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

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