Quality Control Documentation Specialist

1 day ago

Remote, Oregon, United States Katalyst Healthcares & Life Sciences Inc Full time $60,000 per year

Responsibilities:

  • Defines scope of quality control activities with the document author and the required source documents and data required.
  • Conducts independent quality control review of documents per applicable checklist by checking against source documents to ensure results are accurate.
  • Ensures quality control documentation is complete and accurate and uploaded to the master file per the established business processes.
  • Maintain strong knowledge of clinical regulatory documents requiring quality control review and business processes.
  • Interacts daily with medical writers and/or medical writing managers and interfaces/communicates with applicable cross-functional areas.
  • Communicates and provides deliverables to medical writers, medical writing managers, and others as applicable.

Requirements:

  • Bachelor's degree required.
  • Bachelor's degree in Science, English, or Communication preferred.
  • 2-3 years in relevant industry experience in quality control/review of clinical regulatory documents or related experience in an area such as quality assurance, clinical research, drug development, medical writing, regulatory, or product support/R&D. Note: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.
  • Excellent knowledge of organization and content of clinical documents and eCTD structure.
  • Knowledge of drug development and experience with Common Technical Document (CTD) content templates.
  • Excellent oral/written communication, interpersonal/organizational, analytical/critical thinking, and conflict management skills.
  • Superior attention to detail and ability to prioritize multiple tasks/projects.
  • Experience in working with collaborative cross functional teams.
  • Operates with limited oversight.
  • Prepares technical documents to support both domestic and international regulatory submissions.
  • Incorporates text, graphs, charts, tables and statistical analysis.
  • Proofreads, circulates, edits, assembles, inspects and duplicates product submissions.

Job Type: Contract

Pay: $ $29.04 per hour

Work Location: Remote

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