Karen Pu

Experience

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  BIOMECH - Paonan Biotech Co., Ltd.

  Apr 2016 - Oct 2017

  Medical Science Liaison & Medical Device Engineer

  1.Maintain effective communication and collaborative relationships with external experts and physicians-Develop new clinical research opportunities-Project management and business support-Clinical research and trial design capabilities-Training (ISO13485 internal auditor) and presentation skills-Service and client relationship abilities2.Discuss clinical potential risks and research design analysis with clinical specialists-Track the real-world status of patients with the interspinous fixation system-Complete the research project for the interspinous fixation system at Changhua Christian Hospital-Design research for the interspinous fixation system, organize and analyze data, and assist in applying for publication in international SCI journals3.Post-market surveillance, statistics, and data analysis for medical device products-Investigate user satisfaction post-surgery for the interspinous fixation system-Track user feedback post-surgery for the orthopedic system-Monitor product user risks and provide feedback to the risk management system-Actively participate in the operation of orthopedic systems in hospital operating rooms4.Documentation, organization, and report compilation for front-end R&D of medical devices (Taiwan, China, EU, Japan)-Prepare technical documentation for the cervical disc system, lumbar interbody fusion system, and disc maintenance system for EU (CE)-Prepare technical documentation for the auxiliary intervertebral fixation system for Japan (PMDA)-Integrate technical documentation for the interspinous fixation system, lumbar disc fixation system, and spinal pedicle screw fixation system for China-Establish the quality plan for the pedicle screw system Show less

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  Protech Pharmaservices Corporation, PPC (Novotech Health Holdings)

  Nov 2017 - Apr 2018

  Medical Writer

  1.Responsible for writing clinical trial protocols, CRFs, and IRB documents for medical devices and drugs.2.Responsible for interim and final clinical trial reports3.Professional application of medical statistics4.Clinical research design5.Medical literature review studies

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  財團法人醫藥品查驗中心 (Center for Drug Evaluation, CDE)

  May 2018 - now

  Medical Device

  • Senior Project Manager

    Jun 2023 - now

  • Project Manager

    May 2018 - Jun 2023