Michael Hart, Ph.D.

Michael Hart, Ph.D. Email and Phone Number

Senior Medical Writer @ DRAGONFYRE Group
Louisville, KY, US
Michael Hart, Ph.D.'s Location
Philadelphia, Pennsylvania, United States, United States
Michael Hart, Ph.D.'s Contact Details

Michael Hart, Ph.D. work email

Michael Hart, Ph.D. personal email

n/a
About Michael Hart, Ph.D.

Medical writer with 7+ years of experience in preclinical and translational research.

Michael Hart, Ph.D.'s Current Company Details
DRAGONFYRE Group

Dragonfyre Group

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Senior Medical Writer
Louisville, KY, US
Michael Hart, Ph.D. Work Experience Details
  • Dragonfyre Group
    Senior Medical Writer
    Dragonfyre Group
    Louisville, Ky, Us
  • Technical Resources International, Inc.
    Medical Writer
    Technical Resources International, Inc. Nov 2023 - Nov 2024
    Bethesda, Md, Us
    -Reviewed clinical study concepts for scientific accuracy and research plan consistency.-Prepared meeting summaries, reports, and requests for medical officers for cancer clinical trials in the United States and internationally.-Conducted literature reviews to identify safety concerns with investigational agents and to prepare reports on agent background information.-Performed QC review of regulatory and medical writing documents.-Authored protocols, informed consent documents, Central Institutional Review Board (CIRB) documents and associated protocol documents in coordination with study teams for oncology studies.-Developed and maintained the Development Safety Update Reports (DSURs), clinical study reports (CSRs), Comprehensive Adverse Events and Potential Risks Lists (CAEPRs), and study protocols to support clinical trials for more than 200 INDs.
  • Jazz Pharmaceuticals
    Contingent Worker In Global Ist & Eap Operations
    Jazz Pharmaceuticals Sep 2022 - Oct 2023
    Dublin, Ie
    -Led review committee meetings and collected feedback from review committee subject matter experts on submitted concepts and research protocols.-Experience in collecting data for study management tools (SMTs), and supported in the updating of the Tableau IST SMT Dashboard to monitor clinical and preclinical study progress.-Experience in supporting Jazz contracting team in agreement negotiations with external institutions sponsoring Jazz-approved trials.-Led all operations for Oxybate studies and JZP150 Expanded Access Program (EAP) requests and supported IST operations for Sativex and US-approved Epidiolex studies.-Skilled in conducting quality control of all submitted concepts and protocols in VisionTracker and iEnvision to ensure alignment with strategic research objectives in conjunction with the larger development team.-Coordinated deadlines with and collected study files from principal investigators and medical science liaisons for approved and ongoing ISTs.-Expertise in conducting fair-market value (FMV) analyses of submitted IST budgets and processing invoices for completed study milestones in coordination with Accounts Payable.-Aided in reviewing and updating standard operating procedures (SOPs) within IST and EAP operations.
  • University Of Pennsylvania School Of Medicine
    Research Assistant
    University Of Pennsylvania School Of Medicine Mar 2018 - Sep 2022
    Pa, Us
    -Synthesized and developed targeted and activatable fluorophores for detection of non-small cell lung cancer.-Designed protocols for evaluating fluorescence imaging of human, canine, and murine lung tumor tissues.-Compared lung tumor fluorescence resulting from prototype fluorophore administration to fluorescenceresulting from application of FDA-approved fluorophores.-Coordinated with clinical and veterinary teams to obtain patients samples for fluorophore validation.-Mentored high school, undergraduate, and graduate students in molecular imaging techniques.-Aided in NIH grant writing and editing for optical imaging projects.-Prepared abstracts, poster presentations, slide decks, and manuscripts detailing the results of the thesisproject.
  • Centre College
    John C. Young Scholar
    Centre College May 2016 - May 2017
    Danville, Ky, Us
    -Designed a research project analyzing the effects of antibodies on amyloid-beta aggregation (one of the primary causes of Alzheimer's disease progression) and testing the efficacy of a widespread assay technique. Applied and interviewed for the program (one of seven students taken for the 2016-17 academic year). Funded by Centre College.-Conduct experiments improving skills in assay development and SDS-polyacrylamide gel electrophoresis.-Will give a presentation and write a report in April summarizing the results of my research.
  • Centre College
    New Student Orientation And Greek Life Coordinator
    Centre College Aug 2016 - Dec 2016
    Danville, Ky, Us
    -Aid the Director of Greek Life in organizing Greek events and informing the Department of Public Safety of all Greek activities.-Organize information for the Greek chapters on campus for the Director of Greek Life, including member rosters and the preparation of policy forms.-Manage the scanner entry and exit system utilized to track attendance at Greek-sponsored events.
  • Centre College
    Research Assistant
    Centre College Feb 2015 - Aug 2016
    Danville, Ky, Us
    -Conducted organic chemistry research screening the potential of peptide-linked metal chelators to inhibit amyloid-beta aggregation (one of the primary causes of Alzheimer's disease).-Gained experience using UV spectroscopy, assay development, nuclear magnetic resonance spectroscopy, high performance chromatography, SDS-polyacrylamide gel electrophoresis, solid-phase polypeptide synthesis, and organic synthesis.-Presented research at the 252nd National Meeting of the American Chemical Society in Philadelphia.
  • Centre College
    Teaching Assistant
    Centre College Feb 2016 - May 2016
    Danville, Ky, Us
    -Assisted in instruction and laboratory management in an introductory course to biochemistry and molecular biology.-Proctored quizzes and maintained the laboratory in the absence of the professor.

Michael Hart, Ph.D. Skills

Drug Development Assay Development Sds Page High Performance Liquid Chromatography Nuclear Magnetic Resonance Uv/vis Spectroscopy Ir Spectroscopy Organic Synthesis Peptide Synthesis Leadership Cell Culture Immunohistochemistry Immunocytochemistry Small Animal Imaging Immunoprecipitation

Michael Hart, Ph.D. Education Details

  • University Of Pennsylvania School Of Medicine
    University Of Pennsylvania School Of Medicine
    Pharmacology
  • Centre College
    Centre College
    Biochemistry And Molecular Biology

Frequently Asked Questions about Michael Hart, Ph.D.

What company does Michael Hart, Ph.D. work for?

Michael Hart, Ph.D. works for Dragonfyre Group

What is Michael Hart, Ph.D.'s role at the current company?

Michael Hart, Ph.D.'s current role is Senior Medical Writer.

What is Michael Hart, Ph.D.'s email address?

Michael Hart, Ph.D.'s email address is mi****@****tre.edu

What schools did Michael Hart, Ph.D. attend?

Michael Hart, Ph.D. attended University Of Pennsylvania School Of Medicine, Centre College.

What skills is Michael Hart, Ph.D. known for?

Michael Hart, Ph.D. has skills like Drug Development, Assay Development, Sds Page, High Performance Liquid Chromatography, Nuclear Magnetic Resonance, Uv/vis Spectroscopy, Ir Spectroscopy, Organic Synthesis, Peptide Synthesis, Leadership, Cell Culture, Immunohistochemistry.

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