Prepare and review clinical documents that are part ofregulatory submission including but not limited to Protocol, Clinical StudyPharmacology Report, Clinical Study Report, Narratives, and Post ApprovalDocuments across the Therapeutic Areas.

Quality check of the clinical documents that are part ofregulatory submission including but not limited to Protocol, Clinical StudyPharmacology Report, Clinical Study Report, Narratives, Clinical Summary ofSafety, Clinical Summary of Efficacy and Common Technical Document Modules.

Initiates start up meetings with the Study Teams related tothe creation and development of the clinical document for regulatorysubmission, if required.

To work in coordination with all the members in the studyteam- internal and external for the development of clinical documents.

Share project timelines amongst the study team for thedevelopment of document.

Prepare Clinical Documents according to the StandardOperating Procedures, Document Standards and Guidance document.

Review statistical analysis plans and table/figure/listing,when required

Desired Candidate Profile
Qualifications :BACHELOR OF PHARMACY, MASTER OF PHARMACY