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
credit-card $50 per day ($6.25 per hour)

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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Skills

Da
Data Science
Mi
Microsoft Powerpoint
Mi
Microsoft Word

Experience Level

Data Science
Expert
Microsoft Powerpoint
Expert
Microsoft Word
Expert

Language

English
Fluent
Spanish; Castilian
Beginner

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

Industry Experience

Healthcare, Life Sciences, Manufacturing, Other
    uniE613 Informed Consent for Clinical Trials
    Technical article discussing requirements of informed consent for clinical drug trials. #pharma #clinicaltrials #drug #consent
    uniE613 Off label drug use
    FEATURE piece about off label drug use in the USA. #pharma #regulatorycompliance #drug #offlabel
    uniE613 API Manufacturing Risks, Costs, and Benefits
    Annotated Bibliography of API manufacturing. #drug #API #pharma #FDA

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