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Report Writer

Alliance Pharma Inc

  • Malvern, PA
  • 15 days ago

    Highlights

    Complete all paperwork in compliance with good record keeping principles; correctly and on time in compliance with GLP/GCP and in accordance with Good Documentation Practices (GDP). Make suggestions for how processes can be improved and efficiency maximised, to include revising and/or creating report templates, lab manuals and other items as needed.

    Numbers & Facts

    LocationMalvern, PA

    Description

    • Have a good knowledge of the appropriate GLP/GCP standards and latest regulatory guidelines, to include 21CFR Part 11.
    • Be familiar with, and work in accordance with, SOPs and Study Documents.
    • Complete all paperwork in compliance with good record keeping principles; correctly and on time in compliance with GLP/GCP and in accordance with Good Documentation Practices (GDP).
    • Prepare documents in accordance with requirements. Be able to effectively communicate findings and summaries from study data.
    • Utilize LIMS and other data systems to prepare data, chromatograms, tables, and figures for inclusion in reports.
    • Work with scientific teams regarding technical and study details.
    • Responsible for overseeing report lifecycle, addressing QA audits, and submission of reports to clients.
    • Be flexible; realise that timelines, priorities and requirements will change regularly and respond to these challenges accordingly.
    • Ability to plan and organise your work, while being aware of required timelines. Manage your own time and challenge yourself to identify and champion process improvement opportunities
    • Make suggestions for how processes can be improved and efficiency maximised, to include revising and/or creating report templates, lab manuals and other items as needed.
    • BA/BS in a science or related field preferred; all experiences will be evaluated
    • Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP.
    • Demonstrated knowledge of scientific or technical writing, with proven written skills
    • Able to work in a regulated environment
    • Able to work effectively and contribute within a team
    • Able to work with computer systems; in-depth knowledge of Microsoft Office.
    • Able to document clearly

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