Samahita Research Solutions is a leading clinical research and medical writing organization specializing in biotech, pharmaceuticals, and healthcare communications. With a strong presence in the life sciences sector, we provide end-to-end clinical trial support, regulatory submissions, and scientific documentation.
Our team comprises industry experts dedicated to innovative research, compliance, and patient safety. Join us to contribute to cutting-edge medical advancements in a dynamic work environment.
📝 Job Description: Medical Writer
Key Responsibilities:
✔ Develop and review clinical trial protocols, investigator brochures, informed consent forms (ICFs), and study reports.
✔ Ensure compliance with ICH-GCP, FDA, EMA, and other regulatory guidelines.
✔ Provide medical and scientific expertise for INDs, NDAs, CTDs, and other regulatory submissions.
✔ Collaborate with cross-functional teams (Clinical Operations, Regulatory Affairs, Data Management) to meet project deadlines.
✔ Perform literature reviews, data analysis, and scientific writing for manuscripts, abstracts, and presentations.
✔ Address medical queries, safety concerns, and protocol deviations during trials.
✔ Support business development by contributing to proposals and client interactions.
✔ Stay updated with industry trends, guidelines, and therapeutic advancements.
🛠 Skills & Qualifications:
- Education: Bachelor’s/Master’s in Life Sciences, Pharmacy, Medicine, or related fields.
- Experience: Minimum 2 years in medical writing (regulatory documents, clinical research, or publications).
- Strong knowledge of clinical trial processes, ICH-GCP, and regulatory requirements.
- Excellent scientific writing, editing, and communication skills.
- Proficiency in Microsoft Office, PubMed, EndNote, and reference management tools.
- Ability to work in a fast-paced, deadline-driven environment.
📌 How to Apply?
Eligible candidates can send their updated resume to ➡️ career@samahitha.com
📩 Subject Line: “Application for Medical Writer – Immediate Joiner”
