Description
I have a Regulatory Medical Writer (CSR/IB/Narratives) contract requirement (6-12 month) based in Andover MA. My client requires an experienced Regulatory Medical Writer who can hit the ground running in regulatory documents such as CSR's, IB's and Narratives.Key skills and experience required:
-Proven track record in writing Clinical Study Reports (CSR), investigatory brochures (IB's) and SAE narratives
-Strong knowledge of FDA regulatory requirements
-IND/NDA submissions experience
-Knowledge of good publication practice (GPP) and ICH guidelines
-Strong ectd knowledge
The successful regulatory writer will join an existing team, but will need minimal supervision and refers independently to pre-established guidelines to perform the functions of the job. Some remote work is available for the right person.
If you are interested please attach an up to date CV and I will be in touch.
To find out more about Real please visit www.realstaffing.com