Julia Kopaczyńska

Freelance Medical Writer at Proper Medical Writing Sp. z o. o.
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Contact Information
us****@****om
(386) 825-5501
Location
Gdańsk, Pomorskie, Poland, PL
Languages
  • polski Native or bilingual proficiency
  • angielski Full professional proficiency
  • niemiecki Limited working proficiency
  • francuski Elementary proficiency

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Credentials

  • Writing in the Science
    Stanford University
    Mar, 2021
    - Nov, 2024
  • Clinical Research Academy Program
    VIARES
    Jul, 2020
    - Nov, 2024
  • e-learning course ICH GOOD CLINICAL PRACTICE E6 (R2)
    The Global Health Network
    Jul, 2020
    - Nov, 2024
  • Goethe-Zertifikat C1
    Goethe-Institut e.V.
    Jun, 2019
    - Nov, 2024

Experience

  • Proper Medical Writing Sp. z o. o.
    • Poland
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Freelance Medical Writer
      • Apr 2021 - Present

  • Parexel
    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior Regulatory Affairs Associate
      • Jan 2021 - Present

  • Cognizant
    • United States
    • IT Services and IT Consulting
    • 700 & Above Employee
    • Senior Regulatory Affairs Specialist
      • Jan 2019 - Dec 2020

      -Developing and understanding of regulations, guidelines, procedures and policies relating to the drugregistration process;- Responsibility for regulatory submission/dossier publishing activities (eCTD, paper and local dossierformats) for USA, Canada and Latin America;- Preparing IND, NDA, BLA, and DMF submissions (e.g. original applications, safety reports, protocolamendments, DSUR, PBRER, PSUR, annual reports) according to ICH and FDA guidelines;- Performing high-level of files’ formatting using the client provided software;- Interacting with relevant stakeholders during preparation and quality control of reports and regulatorydocumentation;- Managing, creating and archiving regulatory documents and correspondence in internal DocumentManagement System;- Performing quality check of work and providing support for other regulatory related activities;- Proactively troubleshooting technical/quality issues related to the preparation and dispatch of submissions;- Conducting training for our team (including new-joiners). Show less

    • Junior Regulatory Affairs Specialist
      • Jan 2018 - Jan 2019

  • Biovico
    • Poland
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Junior R&D Scientist
      • Jun 2016 - Dec 2017

      - Development of in vitro experimental models- Execution and interpretation of cell based experiments to optimize compound selection and explore itstherapeutic potential

    • Internship
      • Mar 2016 - Jun 2016

Education

  • Intercollegiate Faculty of Biotechnology UG-MUG
    Master of Science, Biotechnologia
    2010 - 2015
  • Heinrich-Heine-Universität Düsseldorf
    Biolotechnology
    2014 - 2015
  • Akademia Leona Koźmińskiego (Kozminski University)
    Postgraduate, Conducting and Monitoring of Clinical Trials
    2017 - 2018

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