Junior Medical Writer Intern

Roles & Responsibilities
• Assist in preparation, formatting, and compilation of clinical trial documents such as Protocols, Investigator Brochures (IB), Informed Consent Forms (ICF), and Clinical Study Reports (CSR)
• Support senior medical writers and medical leads in reviewing documents for accuracy, clarity, and regulatory compliance
• Ensure documents align with ICH-GCP guidelines, ethical standards, and medical writing best practices under supervision
• Coordinate document review cycles and track comments from Clinical Operations, Data Management, and Regulatory teams
• Assist in compiling documentation for regulatory submissions including INDs and NDAs
• Support ongoing clinical trials with documentation related to safety data, protocol amendments, and medical queries
• Conduct literature searches and summarize scientific and clinical information
• Maintain version control and document management records as per quality standards
• Assist in preparing presentations, reports, and client-facing materials
• Adhere to patient safety, data confidentiality, and ethical research practices at all times

Qualification
• Educational background in Pharmacy, Life Sciences, Biotechnology, Clinical Research, or related disciplines

Skills
• Basic understanding of clinical trials and medical writing concepts
• Familiarity with ICH-GCP guidelines (preferred but not mandatory)
• Strong written communication skills and attention to detail
• Willingness to learn regulatory and clinical documentation standards
• Good coordination and time management skills
• Availability for immediate joining in Bengaluru

About the Company
Samahitha is a growing organization in the clinical research and healthcare domain, focused on delivering high-quality clinical and regulatory documentation services. The company provides hands-on learning opportunities, professional mentorship, and real-world exposure to clinical trials and medical writing, making it an ideal place for fresh graduates to begin a career in medical writing and clinical research.