US FDA Compliance Safety Officer with 10+ years’ in Quality Assessments and Compliance.

Master’s degree In Regulatory Sciences (Johns Hopkins ’22). Over a decade of experience within the healthcare field, leadership positions, promoting clinical operations and treatment plans, overseeing training, billing, and accomplishing expansion within any given position. Project manager, Trials Assistant, Medical Device Auditor, and Site Contract Specialist with years of experience working with Contract Research Organizations (CROs), ensuring that all aspects of the clinical trials are adequately negotiated, collected, and authenticated. Exceptional interpersonal communication skills, proficiency, and ability to appropriately interact with medical staff in varying positions. Profoundly skilled in Electronic Data Capture (EDC) systems and well versed in FDA regulations and the ICHGCP in conjunction with applicable local and international regulations such as 21 CFR Part 11, Part 820, and ISO 13485. Highly motivated to excel, accomplish goals, remain determined and learn with an open-minded attitude. Elevated level of adaptability and experience with multiple practice management systems, clinic operations and electronic health records. Strong knowledge of the pharmaceutical industry, including an understanding of clinical drug and device development processes and associated documents (SOPs/Guidelines/Work Instructions). Effective and skilled organizational skills, attention to detail, adaptability, and aptitude to thrive in changing environments. Knowledgeable in clinical database applications (EDC, CDASH, SDTM, Medidata Builder, MedDRA & WHODrug Dictionaries, CTMS system, eCaselink etc.) Passionate about adhering to core values and performing at an exceptional level daily.