Cliantha Research, a full-service Clinical Research Organization (CRO), is a leading provider of Clinical research services, based in Ahmedabad, India. Cliantha’s motto is Science with Integrity. Cliantha has fifteen years of impeccable regulatory history with USFDA, WHO, MHRA, Health Canada, AGES, AEMPS, MCC, MOH, ANSM, MOPH, ANVISA, CAP, and NABL.
Post : Medical Writer
Department : Consumer Research
Basic qualification required : B.Pharm / M. Pharm, M.Sc
Experience : 2 - 6 Years
Job Description
• Preparation of Protocols, Informed Consent Forms, Case Report Forms, and other protocol related documents as per applicable regulatory requirements in consultation with Group In-charge, Principal Investigator, Biostatistician, Analytical Investigator, and Head of the department.
• Coordination with study personnel and other departments for protocol related issues for finalization of protocol.
• Approval of protocols from Ethics committee in consultation with Principal Investigator and Sponsor.
• Responsible for updating the protocol related concerns to investigator(s), sponsor and IEC
• Preparation and revision of related SOPs.
• Conforms to training schedule for own position and maintains awareness of SOPs contents according to company requirements.
• Stays current with the ongoing changes in the pharmaceutical regulatory environment, i.e. FDA, GCPs, GLPs, etc
Location : Ahmedabad
Last date : 15th August, 2023
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