Medical Writing Quality Control Specialist - (Remote US)

Requisition Number: 2585

Position Title: Senior Quality Control Specialist

External Description:

RESPONSIBILITIES:

• Perform quality check of documents, including Protocols, Informed Consent Forms, and Clinical Study Reports.
• Review documents for accuracy of data and information presented.
• Verify document completeness and consistency within a document and between related documents.
• Verify that document was consistent with project-specific writing conventions, including template and style guide.
• Verity that regulatory documents meet ICH and other applicable regulations.
• Provide direct support to the medical writers to ensure timely, high-quality deliverables.
• Provide regular status reports to the Medical Writing QC Manager and Director of Medical Writing.
• Assist with tracking of medical writing deliverables and project metrics.

Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

• Oral and written communication skills
• Planning and organizational skills
• Ability to work independently and in teams
• Knowledge of medical terminology

 
REQUIREMENTS:  

• BA/BS degree
• 2+ years of medical copy editing experience
• Knowledge of AMA style guide
• Proficient use MS Office products
• Working knowledge of ICH guidelines, FDA regulations.
• General understanding of clinical research

This position can be remote in the US.

#LI-EW1 #LI-Remote

City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Medical Writing Quality Control Specialist - (Remote US)

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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