Medical Writer

Role & responsibilities

Write study protocols, synopses, and Clinical Study Reports (CSRs) across Pharma Regulatory,

Observational, and Medical Device studies

• Draft quotations and scope-of-work documents to support Business Development proposals
• Prepare monographs and regulatory dossier content where required for client submissions
• Support manuscript writing and journal submission for sponsor publications
• Ensure all documents meet applicable regulatory (CDSCO, ICH) and journal formatting standards
• Coordinate document review cycles with Clinical Operations, Data Management, and Biostatistics

for accuracy

• Maintain a document template library to standardise turnaround across study types
• Support literature review and background sections for protocols and manuscripts

Preferred candidate profile

M.Pharm, PhD, or equivalent Life Sciences qualification

• Minimum 3-4 years of medical writing experience in a CRO or pharmaceutical company
• Strong scientific writing and editing skills in English, with a portfolio of protocols, CSRs, or

manuscripts

• Working knowledge of ICH E3 (CSR structure) and standard regulatory document formatting

requirements