Job Summary:
The primary purpose of this job is to provide support for document approval/finalization and preparation for publishing; submission of documents to clinical study Trial Master File and QC of Trial Master File, including remediation
Principal Accountabilities:
• Assist Medical Writing Operations staff with document approval and notification processes and maintenance of the Trial Master File, including submission of documents and routine QC and remediation. 90%
• Assist Medical Writing staff with document formatting/troubleshooting/reference management. 10%
• Impacts quality of clinical documentation. Liaises with staff across Development Sciences and Global Medical.
Knowledge & Skills:
• Advanced Microsoft Office skills (Word, PowerPoint, Excel); familiarity with Adobe, Documentum, other systems as needed.
• Strong attention to detail.
• Ability to multitask in a fast-paced environment.
• Excellent oral and written communication skills.
• Aptitude for learning new systems and technology.
• Familiarity with the clinical development process, understanding of trial master file.
Integrated Resources INC
https://careers.smartrecruiters.com/IntegratedResourcesINC