Ref #: 30534

Employment type: Freelancer - Full-Time

Location: Bangalore/Homebased

Posted: 12-Jul-2021

Description

To independently write, edit and compile documents that are components of clinical/regulatory marketing approval applications for new biologics, drugs, or devices, and to direct other medical writers in the writing, editing and compilation of documents

To assist in the management of medical writing resources

Interpret clinical data
Write clinical trial reports and other regulatory documents
Write and manage NDA, PMA, BLA, IDE, and IND documents (both preclinical and clinical reports of clinical studies)
Provide additional writing and editing services as required (e.g. for publications)
Advise on the content and format requirements for clinical reports and regulatory documents
Perform quality control (review) of documents and assess whether specific project related documents comply with regulatory requirements, client requests and ICON SOPs
Participate in non-project specific activities, including assistance in maintaining the medical writing work schedule
Be responsible for the daily management of assigned medical writing projects
Liaise with project managers and statisticians to ensure the timely implementation of activities related to the production of reports
Keep Medical Writing management informed of project status (e.g. in relation to quality, timelines, progress, and problems)
Participate in the training and supervision of new and junior medical writers
Represent Medical Writing at internal and external meetings
Assist Business Development with the preparation of proposals and cost estimates for medical writing tasks