Amaris Clinical. The organization is hiring experienced professionals in clinical research documentation, ICH-GCP compliance, and BA/BE studies.
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This role is ideal for candidates with a background in B.Pharm, M.Pharm, or Pharm D who want to grow in clinical trial documentation, regulatory submissions, and medical writing careers.
🧪 Job Overview
- Position: Clinical Medical Writer
- Openings: 2
- Experience: 2–3 Years
- Qualification: B.Pharm / M.Pharm / Pharm D
- Industry: Clinical Research / Medical Writing
- Location: India
📋 Key Responsibilities
As part of this clinical medical writing role, you will:
- Prepare clinical study protocols and Informed Consent Documents (ICD) for BA/BE studies and clinical trials
- Develop and review Clinical Study Reports (CSR) as per ICH-GCP guidelines
- Compile regulatory documents for BENOC and Test License (T-License) submissions
- Handle Ethics Committee submissions and approvals
- Coordinate with Ethics Committee members and assist in meetings
- Design and prepare Case Report Forms (CRF) for BA/BE studies
- Collaborate with investigators and clinical operations teams
- Ensure compliance with GCP and regulatory requirements
- Maintain accurate clinical documentation
🎓 Qualifications & Requirements
To qualify for this clinical research job in India, candidates must have:
- Degree in B.Pharm / M.Pharm / Pharm D
- 2–3 years of experience in clinical protocol writing and CSR preparation
- Strong knowledge of ICH-GCP guidelines and regulatory frameworks
- Experience in clinical trial documentation and regulatory submissions
- Excellent communication and documentation skills
- Ability to coordinate with clinical teams, regulatory bodies, and ethics committees
💼 Why Join Amaris Clinical?
- Work in a fast-growing clinical research environment
- Gain exposure to global regulatory standards (ICH-GCP)
- Opportunity to work on BA/BE studies and clinical trials
- Enhance expertise in medical writing and regulatory documentation
- Collaborative and performance-driven culture
📧 How to Apply
Interested candidates can share their updated CV at:
📩 hr@amarisclinical.com

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