Medical Writer

691

Applications

Pune
Full-Time
Junior: 1 to 3 years
3L - 5L (Per Year)
Posted on Feb 15 2023

About the Job

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. 



About the company

CLRI is an advance clinical research institute, Professional Training Centre that has been established to fix the current vacuum of value prepared assets/Professionals by being an urgent connection among Aspirant and Industry. Our excellent center is to elevate Pharmacy, Lifesciences, and Medicine including Paramedical alumni into Clinical Research Industry with our unrivaled long-time Industry or ...Show More

Industry

Education Administration ...

Company Size

51-200 Employees

Headquarter

Bengaluru

Other open jobs from Clini Launch Research Institute