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Posted on: 28 Mar 2024
Job Location: Pune, IN
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.
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