Home - Based Senior Medical Writer

Internationally well-renowned and growing CRO is seeking a senior/principal level medical writer to work on regulatory documents 100% from home with occasional travel to a regional office nearby. The hiring manager is seeking highly experienced regulatory writers to work independently from home! Salary level is up to $100k plus bonus and benefits! 100% full-time and home-based: it's a dream come true!! Travel is only required 2-3 times out of the year for a few days at one time. 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: 212-707-8499!

To find out more about Real please visit www.realstaffing.com [1]

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[1] http://www.realstaffing.com