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.