5.0 - 6.0 years

0 - 0 Lacs

Hyderabad

Remote

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...

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Sr. Medical Writer - Regulatory Writing Gi Group

8.0 - 13.0 years

15 - 27 Lacs

Bengaluru

Work from Office

Job Title: Senior Medical Writer Regulatory Writing Education Requirements: MBBS / PhD / MDS / BDS / MPharm / PharmD/M.Sc/B.Pharma/B.Tech Location: Bangalore (Hybrid as applicable) Experience: 8 to12 years of experience in authoring clinical and regulatory documents supporting global filings, particularly CTD Module 2 and Module 5. Role Purpose: This role involves managing complex medical writing projects, reviewing regulatory deliverables, and mentoring junior writers. The position requires both strategic thinking and hands-on execution in support of global regulatory submissions. Key Responsibilities: Independently prepare and review regulatory documents such as clinical study reports (CSR...

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