Tucson, AZ | Job #: 18-06287
Seeking a Medical Writer to support all medical writing activities associated with the Clinical Science function. This individual should be able to work independently with project team members and the Biostatistics and Data Management staff to draft, edit, and finalize a variety of documents including study protocols, presentations, manuscripts for peer-reviewed publications, clinical study reports and submissions to the Food and Drug Administration (FDA).
Department: Clinical Science
Location: Tucson, AZ, 85755 (Oro Valley)
Hourly Rate: $41/hour
Timeline: January 2019 – 1 year contract with potential for extension based on performance and budget
- PhD preferred or BS with graduate coursework in molecular biology, cell biology, biochemistry or a related field
- Completed AMWA, CMPP, or CMWP certification is desired
- Two years of experience in protocol development, data analysis and report writing in clinical or non-clinical studies
- Experience in study design and data analysis
- Regulatory writing and design control processes
- Oncology and/or vitro diagnostic device experience preferred
- Demonstrated proficiency in typing, use of Adobe Acrobat 9 Pro and Microsoft Office 2010 products including Microsoft WORD, Outlook, and Power Point.
- Experience with EndNote X2.0 and Microsoft Visio 2010 preferred.
- Ability to rapidly develop expertise in FDA guidelines for in vitro diagnostic devices and the statistical basis for sensitivity, specificity and reproducibility testing required for validation and FDA clearance and approval
- Ability to rapidly develop expertise in the company's internal document management system.