Medical Writer
Lifelancer
Date: 11 hours ago
City: Pune, Maharashtra
Contract type: Full time
Job Title: Medical Writer
Job Location: Pune, Maharashtra, India
Job Location Type: On-site
Job Contract Type: Full-time
Job Seniority Level: Executive
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.
Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please use the below Lifelancer link to Apply and view similar roles.
https://lifelancer.com/jobs/view/2e94fea769bd8698f5db175e3079aefb
Apply on Lifelancer Platform
Job Location: Pune, Maharashtra, India
Job Location Type: On-site
Job Contract Type: Full-time
Job Seniority Level: Executive
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.
Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please use the below Lifelancer link to Apply and view similar roles.
https://lifelancer.com/jobs/view/2e94fea769bd8698f5db175e3079aefb
Apply on Lifelancer Platform
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