Sr. Medical Writer- CRO- CSRs/Protocols/REMOTE
Global CRO client is seeking Senior Medical Writers to join their division to assist with late phase (II-IV) work.
It is a remote contract for an initial 6 month duration, likely to extend or potential to convert to full time for the right person!
Regulatory experience required- see brief overview below
* At least 5 years of regulatory medical writing experience in a CRO or pharma environment.
* Experience as lead writer on protocols, CSRs, investigator brochures is required. Experience as a lead writer on IND in eCTD format and FDA meeting briefing documents is preferable.
* Experienced as a lead/primary author of CSRs and Protocols.
* Experienced in developing sections of the common technical document- IND/MAA
* FDA, EMA, or other experience
Education and Experience minimum qualifications to apply:
* Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
* Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years') or equivalent combination of education, training, & experience.
* Experience working in the pharmaceutical/CRO industry preferred
* Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
Sthree US is acting as an Employment Business in relation to this vacancy.