Jim Schweitzer

Roanoke, Virginia, United States Contact Info
1K followers 500+ connections

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About

Jim holds a BA in Cognitive Science and Economics from the University of Virginia and an…

Contributions

Activity

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Experience & Education

  • M&T Bank

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Licenses & Certifications

Publications

  • Lessons Learned from Validating a Cloud-Based IRT System Using the GAMP 5 Approach for Risk Based Validation

    Presentation given at ISPE Annual Meeting, 2013 in Washington, DC

  • Reducing Business Risk While Remaining Compliant with SaaS Solutions

    DIA

    Presentation at Drug Information Association Annual Meeting 2013, Boston, MA

  • Key Considerations in Call Center Management for Maintaining a Unified Message

    CBI

    Presentation at CBI Medical Communications and Information Summit, San Diego, CA

    See publication

Courses

  • Appian Designer - Partner Bootcamp

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  • Fundamentals of Pharmacology

    U Penn - Coursera

Projects

  • YakStack

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    Served as Acting Product Manager for startup organization for ground up development of social communications platform. Jim was responsible for high level system architecture of a system that required on-demand scalability involving Telephony Communication (Voice and SMS) powered by Twilio API, email, media processing and storage, and connected mobile applications.
    Jim participated in the development of the system including Ruby On Rails for web, backend, and API components and Android…

    Served as Acting Product Manager for startup organization for ground up development of social communications platform. Jim was responsible for high level system architecture of a system that required on-demand scalability involving Telephony Communication (Voice and SMS) powered by Twilio API, email, media processing and storage, and connected mobile applications.
    Jim participated in the development of the system including Ruby On Rails for web, backend, and API components and Android Development (Java) for the connected Android application.
    Jim acted as business customer liaison to capture and document requirements and design flows directly from customer/product owner, and communicate those requirements with development team following an Agile (Scrum) methodology.

  • Celgene - Risk Management IVRS Tech Lead

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    Served as Technical Lead and System Owner for Celgene’s Risk Management IVR system for Revlimid (RevAssist) and Thalomid (S.T.E.P.S) from 2005 through 2011. System served as the model adopted by FDA for REMS Elements to Assure Safe Use (ETASU) systems. Produced Computer Systems Validation deliverables to ensure compliance with FDA 21 CFR Part 11. Served as technical liaison between Customer Care call center and IT departments.
    Acted as technical lead for multi-year telephony application…

    Served as Technical Lead and System Owner for Celgene’s Risk Management IVR system for Revlimid (RevAssist) and Thalomid (S.T.E.P.S) from 2005 through 2011. System served as the model adopted by FDA for REMS Elements to Assure Safe Use (ETASU) systems. Produced Computer Systems Validation deliverables to ensure compliance with FDA 21 CFR Part 11. Served as technical liaison between Customer Care call center and IT departments.
    Acted as technical lead for multi-year telephony application integration project including Genesys Framework, GVP, VoiceXML, SIP, Pega PRPC covering all aspects of development such as requirements gathering, design documentation, telephony configuration, programming, testing, disaster recovery, and deployment planning.
    Served as System Owner for electronic dynamic Informed Consent Form application
    Served as Technical Lead for Computer Telephony Integration project for Patient Support (free goods) department.

Languages

  • Spanish

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Organizations

  • ISPE

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    ISPE is an individual membership Society for professionals involved in the manufacture of pharmaceuticals and related products. Engineers, microbiologists, chemists, QA/QC, production, process development, pharmacists, regulatory and training personnel, academia, suppliers, and other professionals contribute their expertise to the industry through their participation in ISPE activities.

  • DIA

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    DIA is a neutral, global, nonprofit association that provides knowledge resources across the full spectrum of medical product development. DIA provides professionals at all levels and across all disciplines access to timely and authoritative information to advance careers, skills, and innovation in the pharmaceutical, biotechnology, medical device, and related fields.

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