Job Details

A company is looking for a Senior Manager, Medical Writing.Key ResponsibilitiesProduce high quality and timely writing deliverablesIndependently plan, write, edit, and format key clinical documentsFacilitate the review and finalization process for documents produced internally and externallyQualificationsBachelor's degree in Life Science or English/Communications with relevant expertise; advanced degree preferred6+ years of experience as a medical writer in a sponsor or CRO settingIn-depth knowledge of Good Clinical Practices, FDA regulations, and ICH guidelinesSuccessful track record of managing multiple projects in a fast-paced environmentExperience with regulatory submissions and eCTD formatting is a plus