Clinical Regulatory Writing

Freyr

5 - 6 years

0 Lacs

Hyderabad

Posted:19 hours ago| Platform:

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Skills Required

drug component Medical Writing module 5 module 2.5 module 2.7 Overview and Summaries Clinical Study Report

Work Mode

Remote

Job Type

Full Time

Job Description

Description

Primary Responsibilities:

Drafting and/or content QC of Module 2.5 and 2.7 for INDs, NDAs, BLAs and other regulatory submissions.
Drafting and/or content QC of clinical sections for Investigators Brochure (IB) and Briefing packages.
Drafting and/or content QC of clinical study protocols and Clinical study reports (CSR)
Perform Quality Check (QC) of clinical documents for consistency, accuracy of data and content.
Assist in gap analysis of regulatory dossier.
Verification of comment resolutions and taking up the document for finalization.

Secondary Responsibilities:

Participate and provide internal training on various technical matters/subjects.
Any other responsibilities given by the reporting lead/manager from time to time.
Preparation of Standard Operating Procedures and workflow process.
Be Audit ready and updated with recent regulatory guidelines.

Interactions (With different internal teams/stakeholders/clients/etc.):

Communication with other team members during the course of work requirements.

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