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Medical Writer
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Medical Writer1106
Applications
1106
Applications
About the Job
Skills
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.
About the company
Industry
Education Administration ...
Company Size
51-200 Employees
Headquarter
Bengaluru
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