Certified Medical Writer
Certified Medical Writer has the responsibility for creating and maintaining the documentation that regulatory agencies require in the approval process for drugs, devices and biologics. These documents contain records, reports and forms pertaining the preparation process, quality protocols and mandate,clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and summary documents that summarize and discuss the data a company gathers in the course of developing a medical product.
DURATION : 2 Months
Course Outline
Module 00 : Carry out preparation of regulatory documents
Module 01 : Coordinate with manager, team members and cross functional teams
Module 02 : Collaborate and coordinate with experts
Module 03 : Carry out reporting and documentation
Module 04 : Maintain a healthy, safe and secure working environment in the life sciences facility
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