Document Review Specialist II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summarized Purpose :

Effectively reviews documents created within or outside of the company to ensure quality of a standard that meets or exceeds clients expectations. Documents include : regulatory submissions integrated clinical study reports serious adverse event narratives study protocols and publications. Ensures integrity of data in tables against source documents. Instructs others outside of the quality review group on the review process.

Essential Functions

• Reviews highly technical documents of all types created within or outside of the company to ensure quality standard that meets or exceeds clients expectations.
• Verifies scientific logic and clarity of the document by verifying data in tables against source documents checking for consistency according to current regulatory standards and guidelines.
• Edits for accuracy consistency and grammatical correctness
• Adjusts schedule to accommodate unexpected requests for priority review.
• Revises scientific language for usage flow clarity and audience appropriateness.
• Proactively queries authors to ensure compatibility with unique preferences and scientifically sound judgment
• Maintains communicates and applies knowledge of current guidelines templates and industry standards

Qualifications :

Education and Experience :

Knowledge Skills and Abilities :

Required Experience :

IC

Key Skills

DRG,Acute Care,Adobe Acrobat,ICD-10,Records Management,Technical Writing,Clinical Documentation Improvement,Documentation Review,Sharepoint,cGMP,Document Management Systems,Document Management

Employment Type : Full-Time

Experience : years

Vacancy : 1