CliniLaunch Research Institute
Location
Pune | India
Job description
Location: Hinjewadi Phase 3, Pune.
Qualifications: B-Pharm, M-Pharm, Clinical experience. And related to the Clinical research field Experience: 2-5 years Note: Bioequivalence, Bio-Availability studies (BA/BA) Mandatory Experience Job Description For Medical Writer Preparation of BA/BE study protocol in compliance with ICH-GCP for various regulatory submission (DCGI/ USFDA / EMA / ANVISA / CDSCO/ TGA/ CANADA) Preparation of clinical trial protocol (Phase III / Phase IV) Preparation of investigator brochure Preparation of feasibility and study synopsis Preparation of informed consent form (ICF)/case report form (CRF) on protocol study design Preparation of protocol amendment, amendment report, list of changes and others documents if any molecule specific and subject safety related. changes based on literature. Preparation of clinical study report (CSR) in compliance to ICH-GCP for various regulatory submissions (DCGI/USFDA / EMA / ANVISA / CDSCO/ TGA/ CANADA) Preparation of clinical and non-clinical overviews for regulatory submission Preparation of DBE summary table for regulatory submission Review of outsourced BA/BE study protocol, ICF, CSR etc.Job tags
Salary
