Role & responsibilities

Position: Medical Writer
Experience: 2-5 Years
Qualification: PharmD/PhD/Master's degree in life sciences

Job Summary

We are looking for a proactive and scientifically driven Medical Writer with 2-5 years of experience in clinical research, preferably in vaccine clinical trials. The successful candidate will develop high-quality clinical and regulatory documents for sponsor projects while ensuring compliance with ICH-GCP and applicable regulatory guidelines.

Key Responsibilities

- Author and review Clinical Trial Protocols, Protocol Amendments, Clinical Study Reports, Synopses, Investigators Brochures, Informed Consent Forms, and other clinical documents.
- Interpret and summarize clinical data accurately.
- Collaborate with Clinical Operations, Pharmacovigilance, Regulatory Affairs,



etc.
- Ensure compliance with ICH-GCP and regulatory requirements.
- Manage multiple writing projects and timelines.
- Support regulatory submissions and process improvements.

Preferred candidate profile

- PharmD or M.Pharm.
- 2–3 years of medical writing experience in a pharmaceutical company or CRO.
- Hands-on experience in vaccine clinical trials.
- Experience writing Protocols and CSRs.
- Solid understanding of ICH-GCP.
- Excellent scientific writing and communication skills.
- Experience supporting regulatory submissions.
- Familiarity with CDSCO guidelines.

📌 Medical Writer (Hyderabad)
🏢 Indian Immunologicals (IIL)
📍 Hyderabad