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Sr. Medical Writer

Remote, CA 92121

Posted: 11/15/2022 Employment Type: Direct Hire/Perm Job Category: Regulatory Sciences and Medical Writing Job Number: 509163 Is job remote?: Yes Country: United States

Job Description

Job Responsibilities:
  • Independently or with minimal supervision write, edit, perform data verification, submit for review, and obtain approval 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
  • 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 develop and manage medical writing processes, SOPs, and templates for key documents
  • Help manage the functional review of study documents produced by other contract writers
  • Keep abreast of professional information and technology through literature, symposia, and conferences
  • 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
  • Experience writing protocols from the design phase
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