Job Description
Job description
Job Location: Ahmedabad (On-Site)
Experience required: 3-6 years in core medical writing, protocol writing for BA/BE.
Company Description
Cliantha Research, a full-service Clinical Research Organization (CRO), provides comprehensive offerings in clinical research, including Early Phase, Late Phase, Respiratory, Tobacco Research, and more. The company focuses on customer-centric services to enable the clinical development of pharmaceutical and healthcare companies. Cliantha has a global presence with advanced clinical sites and bio-analytical laboratories in North America and India.
Role Description
This is a full-time on-site role for a Medical Writer at Cliantha Research in Ahmedabad. The Medical Writer will be responsible for designing and preparation of Protocol, Case report form, Informed consent document and other protocol related documents in consultation with Group-In charge and Investigators, interdepartmental and intradepartmental communication, obtaining approval of protocols from the sponsor and Ethics Committee.
Requirement
A. Preparation of Protocols, Informed Consent Documents, 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.
B. Coordination with study personnel and other departments for protocol related issues for finalization of protocol.
C. Approval of protocols from Ethics committee in consultation with Principal Investigator and Sponsor.
D. Responsible for updating the protocol related concerns to investigator(s), sponsor and Ethics Committee.
E. Preparation and revision of related SOPs.
F. Conforms to training schedule for own position and maintains awareness of SOPs contents according to company requirements.
G. Stays current with the ongoing changes in the pharmaceutical regulatory environment, i.e. FDA, GCPs, GLPs, etc.
Job Location: Ahmedabad (On-Site)
Experience required: 3-6 years in core medical writing, protocol writing for BA/BE.
Company Description
Cliantha Research, a full-service Clinical Research Organization (CRO), provides comprehensive offerings in clinical research, including Early Phase, Late Phase, Respiratory, Tobacco Research, and more. The company focuses on customer-centric services to enable the clinical development of pharmaceutical and healthcare companies. Cliantha has a global presence with advanced clinical sites and bio-analytical laboratories in North America and India.
Role Description
This is a full-time on-site role for a Medical Writer at Cliantha Research in Ahmedabad. The Medical Writer will be responsible for designing and preparation of Protocol, Case report form, Informed consent document and other protocol related documents in consultation with Group-In charge and Investigators, interdepartmental and intradepartmental communication, obtaining approval of protocols from the sponsor and Ethics Committee.
Requirement
A. Preparation of Protocols, Informed Consent Documents, 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.
B. Coordination with study personnel and other departments for protocol related issues for finalization of protocol.
C. Approval of protocols from Ethics committee in consultation with Principal Investigator and Sponsor.
D. Responsible for updating the protocol related concerns to investigator(s), sponsor and Ethics Committee.
E. Preparation and revision of related SOPs.
F. Conforms to training schedule for own position and maintains awareness of SOPs contents according to company requirements.
G. Stays current with the ongoing changes in the pharmaceutical regulatory environment, i.e. FDA, GCPs, GLPs, etc.
💡 Quick Summary
Seeking a career-building opportunity? The Medical Writer position is now open for candidates interested in the Health Jobs sector. This role in Ahmedabad offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Health Jobs is a plus.
