Preparation clinical study reports integrated summaries of efficacy and safety investigators brochures and other documents for domestic and international regulatory submissions to U. S. European and other regulatory agencies.
Will serve as lead writer on large submissions manage project timelines within the group and provide expertise and guidance to team members and to in-house and consulting writers.
8+ years experience with knowledge of ICH/CTD guidelines and working knowledge of bio-statistics are required
• EDUCATION: B. S. or M. S.
• JOB DURATION: This job is full time and long term.