Key Responsibilities:- Write clinical study protocols aligned with ICH-GCP, EU MDR, FDA, and other global regulatory standards
- Conduct systematic literature reviews using databases like PubMed, Embase, and Cochrane
- Prepare and contribute to Clinical Evaluation Reports (CERs) and Clinical Study Reports (CSRs)
- Collaborate with cross-functional teams (medical, regulatory, biostatistics, and data management)
- Define study objectives, eligibility criteria, and endpoints
- Analyze and summarize scientific data to support clinical research initiatives
Requirements:- MBBS/MD (or equivalent medical degree) Required
- Additional qualification in Clinical Research (Diploma, MSc, or PhD) Preferred
- 25 years of experience in medical writing, clinical research, or regulatory affairs
- Excellent written and verbal communication skills
- Strong leadership and collaboration abilities
Work Mode: Full-time, Onsite (Bangalore)
