PPD invites applications for the post of Document Review Specialist for Bengaluru location.
Pharmaceutical Product Development (PPD) is a global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.
- Bachelor’s degree 4 years B. pharm
- Relevant experience including 1 year of experience within the pharmaceutical/medical device industry and 2 years of writing, clinical research, and editing experience or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities Knowledge.
- 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.