Medical Writer

Auriga Research; Gurugram District; Hybrid; INR 700,000 - 1,100,000; Full time

Job summary

Auriga Research is seeking a Medical Writer to craft study protocols, CSRs, and regulatory documents across pharma and medical device studies.

The candidate should have 3–4 years of medical writing experience in a CRO or pharmaceutical setting, with strong English writing/editing skills and familiarity with ICH E3 guidelines. A formal Life Sciences qualification is required.

Qualifications

• 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

Responsibilities

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

Education

M.Pharm, PhD, or equivalent Life Sciences qualification

Job description

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