Description
A key client of mine is urgently seeking Medical Writers for 12 month contracts in New Jersey. The Medical Writer will be responsible for creating regulatory documents, managing the document review process, and formatting/managing documents with multiple review cycles and tight deadlines.An ideal candidate will possess the following qualities:
-experience creating regulatory documents (protocols, protocol amendments, clinical study reports (CSR), investigator brochures (IB))
-intimate understanding of ICH guidelines and the updated AMA Style Manual
-be able to hit the ground running writing regulatory documents in collaboration with study team members (with little to no supervision)
Essential requirements:
-Bachelor's degree in life sciences/RN (Master's degree in life sciences, PharmD, or PhD are preferred)
-Excellent writing skills
-Meticulous attention to detail
-experience using electronic document management system
-strong abilities interpreting/analyzing clinical data
-5+ years experience with regulatory medical writing
The client would prefer someone to be on site 5 days a week; however, remote work is a possibility. Training must be completed on site, but afterwards 2-3 days on site would be sufficient.
Rates are competitive with the market.
Please note: this role requires a 40 hour work week.
If you are interested or know anybody who might be, please send an updated CV and I will be in touch.