1 Draft Protocol Jobs

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Quality Control - Biopharmaceutics and Project Management Veeda CR

3.0 - 5.0 years

3 - 6 Lacs

Ahmedabad

Work from Office

Role & responsibilities To review & comment on the draft protocol, draft Informed Consent Documents (English ICD), draft Case Report Form (CRF) and/or associated documents received from (Medical Writer team) as per SOP and applicable regulatory guidelines. To review & comment on draft report including all appendices (Clinic related sections) and final e-CTD report received from Report writer in accordance with related SOP/regulatory guidelines/sponsor requirement. To review the respective documents as per defined timelines and/or as per the priority. To review the respective documents updated based on sponsor comment, regulatory observation and ensure compliance to the same. To responsible t...

Posted 3 months ago

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