Medical Writer

Role & responsibilities

To Co-ordinate with the Project Manager (PM), Principal Investigator (PI) and/or Clinical Investigator (CI), Bioanalytical team, and Statistician, for protocol preparation

• To prepare informed Consent Documents (ICD) in English and coordinate for translation into Local language(s) and its back translation into English, if applicable.

• To Prepare of the CRFs and other working documents, if applicable.

• To prepare documents for submission to the regulatory.

• Incorporate the protocol comments received from Investigator, QC, QA, BR and Sponsor before finalization of the same.

• Internal QC of study documents

• Literature Search

• To assist Project Manager for feasibility assessment of study proposal.

• Literature survey for PK & Safety study. IEC Communication:

• Co-ordination with Principal Investigator (PI) and/or Clinical Investigator (CI) for application.

• To prepare documents for submission to the Ethics Committee (EC)