Regulatory Medical Writer -REMOTE (CSR/Protocols/IB's) (RE-12518163) New Jersey, USA
I have requirements for Senior Medical Writers for a REMOTE contract position for a leading CRO. I am looking for senior/principal regulatory writers who have worked for 5+ years within regulatory writing for a CRO or major pharma.
Proven track record in Regulatory Medical Writing specifically in writing:
-Clinical Study Reports (CSR)
-Protocols
-Investigator Brochures (IB’s)
- CTD documents; Summaries and Overviews
-Phase III experience
- Safety Reports
- Adherence to FDA/EMA style guidelines
A strong understanding of clinical research, the drug development process, and applicable regulatory guidelines is a must. This is a fully REMOTE position for a leading CRO. If you are interested please attach an up to date resume and I will be in touch.