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.

Minimum Education Requirements: Associate’s Degree required; Bachelor’s Degree preferred.

Minimum Experience Requirements: 1+ year experience in biotech or pharmaceutical company (R&D, Clinical preferred).

With Regards,

Kavita Kumari

Clinical Recruiter

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Inc. 5000 – 2007-2014 (8th Year)

Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70

Tel: 732-549-2030 x208

Fax: 732-549-5549

Direct: 732-549-5302

www.irionline.com

https://www.linkedin.com/in/rkavita