Skills:
DCGI,, USFDA, EMA, ANVISA, CDSCO, CSR, ICH-GCP, ICH-GCP, BA/BE study, ICF,

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.