Job Summary

Job Description

•       The Quality Control Analyst / Biomedical Editor will be responsible for quality control of clinical documents intended for submission to regulatory agencies

•       Coordinate and perform quality control for clinical documents including, but not limited to, protocols, investigator brochures, clinical study reports, patient narratives, and clinical modules of the common technical document

•       Ensure documents comply with appropriate ICH and regulatory guidelines

•       Proofread, review and edit clinical documents in support of clinical development projects in multiple therapeutic areas and at various stages of development in order to verify:

•       Completeness and accuracy of information

•       Accurate use of grammar and style

•       Internal consistency of document

•       Compliance with submission-ready standards

•       Application of format standards

•       Works within document management system to ensure security and version control is maintained

•       Ensures consistent QC across authors and documents

•       Interact directly and independently with client

•       Ability to follow Company and sponsor processes

Requirements:

•       At least 2 years of medical writing, technical editing, or quality control experience

•       Minimum of a bachelor's degree with 3-5 yrs industry experience

•       Preferred: experience with regulated scientific/clinical documentation in a pharmaceutical, biotech or clinical research environment

•       Understands ICH guidelines, as applicable to medical writing for clinical studies

•       Excellent written English skills

•       High degree of organization and able to manage multiple projects at any given time

•       Attention to detail and committed to excellence in all aspects of their work

•       Ability to work under pressure, and to work independently and collaboratively with team

•       Excellent communication and interpersonal skills

•       Proficient in Microsoft Word and Adobe Acrobat

•       Experience in the use of an Electronic Document Management system

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