Job Description Medical Writer

Department: Medical Writing
Reports To: Site Head / Head – Clinical Research

Job Summary

The Medical Writer is responsible for preparing, reviewing, and maintaining high-quality clinical and regulatory documents for Bioavailability/Bioequivalence (BA/BE) studies and Phase I–IV clinical trials. The role ensures that all documents comply with ICH-GCP, NDCTR 2019, CDSCO guidelines, applicable regulatory requirements, and company SOPs.

Key Responsibilities
Prepare and review clinical and regulatory documents, including Protocols, Investigator Brochures (IB), Informed Consent Forms (ICF), Patient Information Sheets (PIS), Clinical Study Reports (CSR), and Case Report Forms (CRF).
Prepare documents for CDSCO/SUGAM, Ethics Committee, and regulatory submissions.
Perform scientific literature reviews and summarize clinical and regulatory information.
Ensure compliance with ICH-GCP, NDCTR 2019, CDSCO requirements, and institutional SOPs.
Coordinate with Clinical Operations, Regulatory Affairs, Biostatistics,



Data Management, and Sponsors for document preparation and review.
Maintain document version control, quality, and timely completion of assigned projects.
Support sponsor audits, QA audits, regulatory inspections, and responses to regulatory queries.

Qualification & Experience
M.Pharm, Pharm.D, M.Sc. (Life Sciences)
Minimum 3–5 years of experience in Medical Writing within a CRO, pharmaceutical company, or clinical research organization.

Required Skills
Solid knowledge of ICH-GCP, NDCTR 2019, CDSCO regulations, and clinical research documentation.
Experience in preparing Protocols, IBs, ICFs, CSRs, CRFs, and regulatory submission documents.
Excellent scientific writing, editing, literature review, and communication skills.
Proficiency in Microsoft Word, Excel, and PowerPoint with robust attention to detail and document management.

📌 Medical Writer Kandla
🏢 Rusan Pharma
📍 Kandla