Medical Writer

Independently prepare, review and finalize the concept sheets Prepare the Clinical Study protocols in compliance to applicable regulatory requirements and associated study documents like ICF, CRF etc. Preparation & finalization of study specific Project Management plans, in consultation with respective Project Manager Write and edit clinical study documents like Concept sheet, Protocols, ICF, CRF, Clinical study reports etc. for all studies at CBCC Prepare, review and finalize SEC presentations in consultation with Medical Monitor and other stakeholders Work very closely with BD and concerned Director or HOD for the delivery of high quality, scientific and regulatory compliant concept sheet to sponsors Coordinate with translation agency for study specific document translations. Work within CBCC to assist with the review and preparation of summary documents that support the clinical/scientific needs of a project. Ensure compliance with the Quality standard requirement of quality management system and relevant documentation and filing. Perform all the other tasks assigned by concerned Director or HOD. Prepare Clinical study report and study report compilation in compliance to applicable regulatory requirements (if required)