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 strong attention to detail and document management.

📌 Medical Writer (Kandla)
🏢 Rusan Pharma
📍 Kandla