Executive - Pharmacokinetics (Clinical Report reviewer)

2 - 6 years

4.0 - 9.0 Lacs P.A.

Vadodara

Posted:2 weeks ago| Platform: Naukri logo

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Skills Required

clinical report writerdocumentationRegulatoryReviewDocument Review

Work Mode

Work from Office

Job Type

Full Time

Job Description

JD of clinical study report writer ( 3-6 yr experience ) Preparation and review of clinical study report for various regulatory agencies like USFDA, EMA, Canada, ANVISA, ROW market(both clinical and PK-Stat portion) eCTD related activities as per regulatory guidance Preparation of various additional documents (e.g. OGD table, CSBE, BSIF, BTIF etc.) as per respective agency requirement . Handling and archival of finally submitted bio-study reports

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