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Veeda CR
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Medical Writer

Medical Writer

4 - 6 years

|

5 - 8 Lacs

Posted:2 hours ago| Platform:

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Skills Required

medical writing ctd ba/be studies protocol writing clinical study report ich

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

To prepare protocol preparation
Incorporate the protocol comments received from Investigator, QC, QA, BR and Sponsor before finalization of the same.
To prepare informed Consent Documents (ICD) in English and coordinate for translation into Local language(s) and its back translation into English, if applicable.
To Prepare of the CRFs and other working documents, if applicable.
To prepare documents for submission to the regulatory.
Internal QC of study documents
Literature Search
To assist the Project Manager for feasibility assessment of study proposal.
Literature survey for PK & Safety study
Co-ordination with Principal Investigator (PI) and/or Clinical Investigator (CI) for application.
To prepare protocol preparations to the Ethics Committee (EC).

Preferred candidate profile

Experience in BA/BE Studies or clinical trial Phase 1 studies

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