Amanda T.
Lead Regulatory Affairs Specialist at Swedish Cancer Institute
- Role
- Lead Regulatory Affairs Specialist at Swedish
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Amanda T.
Creative and critical thinker who initiate and are result oriented. Acknowledged to have managed multiple projects simultaneously in research and clinical settings for more than 10 years.
Experience
Lead Regulatory Affairs Specialist
Oct 2023 — Present · Seattle, WA, US
Provide leadership to the continuous growth of the regulatory team (currently consists of thirteen members), including employee onboarding, training, and improvement program.• Provide leadership and oversight to the process of implementation and interdepartmental integration of a new e-regulatory platform within the organization, as well as continuous improvement to the current clinical trial management system.• Develop, maintain, and implement policies, standards, guidelines, and procedures within the regulatory framework, as well as interdepartmental collaboration regarding clinical research operation within the institution.• Plan, organize, and manage the work of the regulatory team to ensure that performance expectations and outcomes are met.• Responsible for review and assessment in regulatory related protocol deviations within the department. Ensure team members have the necessary resources to complete corrective and preventative action.• Analyze and monitor compliance and violation trends. Develop process and procedures to address the trends, ensure process improvement, and compliance maintenance.• Leads the analysis and interpretation of regulations, programs, and policies to team members.
Education
University of Washington
Master of Science (M.S.), Biomedical Regulatory Affairs
2014 — 2016
University of Washington
Bachelor of Science (BS), Bachelor of Arts (BA), Biochemistry, Chemistry
2011 — 2013
St. Ursula High School
High School Diploma, Natural Sciences
2006 — 2009
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