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Quality Control Editor (Reg Documents)

Remote, CA 92121

Posted: 11/29/2022 Employment Type: Contract Job Category: Quality and Compliance Job Number: 512229 Country: United States Is job remote?: Yes

Job Description

Job Responsibilities:
  • Independently or with minimal supervision edit, perform data verification for clinical and nonclinical regulatory documents including, but not limited to, clinical protocols, clinical study reports (CSRs), investigator's brochures, summary document, and safety reports
  • Perform copy editing for grammar, punctuation, style, and internal consistency
  • Perform formatting of the documents written by a MW, as required
  • Collaborate effectively with other functional area authors to achieve submission schedules as prioritized by senior management
  • Administer QC checks to ensure documents comply with FDA guidelines
  • Help QC medical writing processes, SOPs, and templates for key documents
  • Participate in departmental and cross-departmental initiatives.
  • Provide innovation and be a resource for improving departmental processes.
  • Provide expertise and guidance on document design and principles of good medical writing to department and product teams
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