Independently utilizes experience and expertise to accurately and efficiently manage the submission of regulatory documents to ensure compliance with governing requirements. Offers mentorship and training to new and junior staff and assists in the development of procedures and policies. Manages complex and non-routine regulatory functions. Responsible for making independent decisions regarding protocol issues and resolving protocol deviations.Preferred Qualifications2-3 years of regulatory experience, an understanding of medical terminology and technical writing experience preferred.Oncology clinical trial experience highly preferred.Working knowledge of Food and Drug Administration (FDA) requirements, Office of Human Research Protection (OHRP), International Conference of Humanization (ICH) Good Clinical Practice (GCP), as well as state and federal guidelines.Knowledge of clinical development process sufficient to effectively direct and manage multiple projects and timelines.Strong attention to detail, establishing priorities, and adhering to deadlines.Able to show initiative and work independently, take initiative and complete tasks to meet deadlines.Excellent interpersonal communication (including oral and written) and leadership skills also required.Proficient in standard Microsoft office applications including Word, PowerPoint, Excel, Project, and other project management tools.SOCRA or ACRP certification.Huntsman Cancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve which includes Idaho, Montana, Nevada, Utah, and Wyoming with impact worldwide.In your cover letter or during your interview process, we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institutes mission and this position.