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Role & Responsibilities
• Prepare, review, and quality-check clinical trial documents
• Develop clinical protocols, Investigator’s Brochure (IB), ICFs, CTD modules, CRFs, and safety reports
• Ensure documents comply with SOPs, timelines, and regulatory guidelines
• Conduct literature searches and scientific data interpretation
• Perform QC reviews for accuracy, consistency, and compliance
• Support regulatory submission documentation
Qualification
• B.Pharm or M.Pharm
Experience
• 2–3 years in clinical research, medical writing, or regulatory documentation
• Experience in CRO or pharmaceutical industry preferred
Skills
• Clinical documentation and medical writing
• Regulatory guideline understanding
• Literature review and data interpretation
• Quality control and compliance checks
• Strong written communication
About the Company
• Lambda Therapeutic Research Ltd. is a global full-service CRO
• Operations across India, USA, Canada, UK, Spain, and Poland
• Provides exposure to international clinical trials and regulatory projects