The ESTERN Medical Regulatory Services Center of Excellence is responsible for ensuring that work undertaken by ESTERN Medical Early and Late Stage Development Services meets the requirements of government regulatory agencies locally and worldwide. This responsibility includes the preparation of a variety of clinical documents including protocols and clinical study reports for Phase I to IV clinical trials run by ESTERN Medical globally, in collaboration with other ESTERN Medical units as necessary.
It is the responsibility of the Senior Medical Writer to prepare such documentation to the required standard in a timely fashion. The Senior Medical Writer is also responsible for providing this service and associated advice to clients. The Senior Medical Writer is expected to acquire a competency in the use of Documentum and associated tools.
