Document Coordinator

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.