Description
Exciting growing company seeks experienced regulatory medical writer to join the work from home workforce! We are looking for extremely bright and friendly medical writers to join a fun team of solid writers - strong team environment and fun culture! This year this company plans to grow 25% and next year 50-75%!!! Lots of advancement opportunities and great work-life balance - foreign company looking to carry on with excellent stability and quality of life and work!Responsibilities:
- Write Phase I-IV clinical and regulatory documents and submissions, including IBs, CSRs, protocols, integrated summaries of efficacy and safety, briefing books, CSS, CSE, narratives, regulatory responses and other similar regulatory documents
- Work within tight deadlines and multi-task on projects
-Edit and QC work before it is sent for further reviews
- Prepare content templates for clinical documents that are consistent with FDA and ICH guidelines and with electronic submission guidelines
Requirements:
-GRADUATE DEGREE REQUIRED, MS/PHD/PHARMD PREFERRED
-5 Years of REGULATORY Medical Writing and senior medical writers NECESSARY, not technical nor medical education
-Ability to multi-task and to meet deadlines
-Strong understanding of ICH guidelines and FDA regulations
DO NOT miss out on this once in a lifetime opportunity to get a full-time, home-based job in your dream career! Get experience on a variety of therapeutic areas, and various documents! This opportunity will better your experience and your resume!
Send resumes to Dandan Zhu at Real Staffing now at: !
To find out more about Real please visit www.realstaffing.com