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Report Writer - Biopharmaceutics & Project Management Department

Report Writer - Biopharmaceutics & Project Management Department

Veeda CR

5 - 7 years

6 - 10 Lacs

Ahmedabad

Posted:1 day ago| Platform:

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Skills Required

Regulatory Pharmacokinetics Report Writing CTD Project Reports Clinical Study Report

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Work from Office

Job Type

Full Time

Job Description

Role & responsibilities Prepare clinical study report of BABE studies and patient based clinical trial studies (PK end point/PD end point/clinical end point studies) on the basis of data received from clinic after completion of study as per regulatory requirement/SOPs/client standards/client approved templates. Final compilation of the project report with respected appendices as per e-CTD including Module 2 (Summary report) and Module 5(Compilation of study report, literature, appendices & BR report) and/or applicable regulatory guidelines & requirements. Submit final compilation signed report with e-CTD to client. Co-ordinate with Project Manager for report requirement, sponsor's comments & response. Draft final report and submit to sponsors via project manager. Co-ordinate with BR for bio analytical report and stat for statistical report and submit sponsors via project manager.

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Veeda CR

www.veedaCR.com

Clinical Research, Biotechnology

Los Angeles

201-500 Employees

18 Jobs

Key People

Dr. Kiran Yelne

Managing Director
Ravi Raghavan

Vice President, Business Development

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Report Writer - Biopharmaceutics & Project Management Department

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Report Writer - Biopharmaceutics & Project Management Department

Experience & Salary

Skills Required

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