Job Summary
A staffing agency has an open position for a Telecommuting Senior Medical Writer.
Candidates will be responsible for the following:
- Writing the synopsis and protocol/CIP of clinical trials/investigations and/or of late phase studies
- Developing CRF and related documents such as questionnaires and patient diaries
- Writing the integrated Clinical Study Report
Must meet the following requirements for consideration:
- May be required to travel up to 10%
- BS in a scientific/technical discipline
- Substantial experience in pharmaceutical, biological or device development
- Proven experience as a Medical Writer and management of regulatory documentation
- Experience with multiple NDA/IND submissions
- Previous experience with Medical Devices