Scientist with 8+ years of experience in FDA-regulated pharmaceutical companies. I have created risk assessment programs for microbial contamination in production. I have expert skills in technical/scientific writing and have a generous knowledge of regulatory compendia from FDA, EU, ICH.…

Julia SH

Scientist with 8+ years of experience in FDA-regulated pharmaceutical companies. I have created risk assessment programs for microbial contamination in production. I have expert skills in technical/scientific writing and have a generous knowledge of regulatory compendia from FDA, EU, ICH.…

Available to hire

Scientist with 8+ years of experience in FDA-regulated pharmaceutical companies. I have created risk assessment programs for microbial contamination in production. I have expert skills in technical/scientific writing and have a generous knowledge of regulatory compendia from FDA, EU, ICH.

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Language

English
Fluent
Spanish; Castilian
Beginner

Work Experience

Add your work experience history here.

Education

Bachelor of Science at Colorado State University
August 17, 2011 - August 1, 2016
Bachelor of Biological Science
Masters of Regulatory Science at Arizona State University
January 11, 2023 - April 22, 2024
Currently enrolled

Qualifications

Add your qualifications or awards here.

Industry Experience

Healthcare, Life Sciences, Manufacturing, Other
    paper Informed Consent for Clinical Trials
    Technical article discussing requirements of informed consent for clinical drug trials. pharma clinicaltrials drug consent…
    paper Off label drug use
    FEATURE piece about off label drug use in the USA. pharma regulatorycompliance drug offlabel…
    paper API Manufacturing Risks, Costs, and Benefits
    Annotated Bibliography of API manufacturing. drug API pharma FDA…

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