QC Regulatory Document Reviewer (eCTD Format) (reputed company/Biotech)

Remote 1 year assignment Experience Level = 3-5 Years • Defines scope of reputed company control activities with the document author and the required reputed company documents and data required. • Conducts independent reputed company control review of documents per applicable checklist by checking against reputed company documents to ensure results are accurate. • Ensures reputed company 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 reputed company 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. • Bachelor’s degree required. Bachelor’s degree in Science, English, or Communication preferred. • 2-3 years in relevant industry experience in reputed company control/review of clinical regulatory documents or reputed company experience in an area such as reputed company 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 reputed company 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/reputed company. • Experience in working with reputed company cross functional teams. • Operates with limited reputed company.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: $43.00 - $45.00 per hour Expected hours: 40 per week Benefits: • Health insurance Education: • Bachelor's (Preferred) Experience: • QC Review of Clinical or Regulatory documents: 3 years (Preferred) • reputed company/biotech industry: 3 years (Preferred) • eCTD format, Common Technical Document (CTD): 3 years (Preferred) Ability to Commute: • Remote (Preferred) Work Location: Remote Apply tot his job Apply To this Job