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Bioagilytix

Posted 5 days ago

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Technical Writer (Casual, FT)

MelbourneOn-site

AI Summary

A Technical Writer prepares clinical study reports and related documents, supports project planning and data analysis, and ensures compliance with quality and regulatory standards for clinical projects.

About this role

360biolabs is Australia's most comprehensive quality-accredited specialty laboratory services organisation. 360biolabs is a BioAgilytix company and part of a leading global contract research organisation (CRO) supporting the development of innovative new medicines in a quality-controlled environment. At 360biolabs, we develop and conduct pharmacokinetics (PK) and pharmacodynamic (PD) assays across a wide variety of therapeutic areas to ensure the success of our clients' clinical trials and preclinical studies.
Working at 360biolabs means working with the best people (and technology) in our field. With a genuine focus on development, you will have access to local and global opportunities. You will also have access to a diverse offering of wellbeing and connection initiatives which reflects that people are our priority.

The purpose of this role is to assist in the management of clinical projects supported by 360biolabs. Responsible for preparing clinical study associated reports and documents to support the high-quality collaborative R&D at 360biolabs for clients to NATA R&D. This role is offered on a casual basis, ideally 5 days per week, but happy to discuss for the right applicant.

Key Responsibility Areas

  • The key responsibility areas (KRAs) are the major outputs for which the position is responsible and are not a comprehensive statement of the position activities.
    • Project Management
  • Assist in the planning and start-up activities associated with the implementation of new clinical studies
  • Liaise with colleagues to ensure study activities are delivered consistent with Work Order timelines
    • Data analysis, Reporting and Document work
  • Maintain records to levels consistent with relevant standards
  • Prepare and review reports related to assay validation, assay qualification, assay qualification, laboratory manuals, analytical protocols and study reports
  • Produce reports for internal use and communication to clients
    • Quality & Accreditation
  • Adhere to ISO/IEC 17025, the OECD Principles of Good Laboratory practice, 360biolabs’ Quality Management System, SOPs, and other requirements as per NATA Accreditation and regulatory guidelines
  • Maintain awareness of, and ensure compliance with, relevant International Standards and Guidelines including ICH GCP
    • Team Work
  • Maintain high levels of communication with colleagues and maintain productive relationships with clients, CROs, collaborators and partners
    • Professional Development
  • Attend meetings associated with clinical research and the work of 360biolabs
  • Participate in professional activities including attendance at training courses and seminars as required

    • Key Selection Criteria

  • Bachelor of Science (Hons) or equivalent qualification plus relevant experience (Essential)
  • PhD in a Biological discipline or equivalent experience (Desirable)

    • Experience / Knowledge / Attributes

  • Experience in medical laboratory techniques (Essential)
  • Experience with preparation of technical documents (Desirable)
  • Excellent organisational and writing skills (Essential)
  • Ability to work as part of a team (Essential)
  • Good communication skills (Essential)
  • Proficient in use of Word Office, including Word, Excel, and PowerPoint (Essential)
  • Experience with database software and file management (Essential)
  • Experience in the conduct of clinical trials (Desirable)
  • High motivation and enthusiasm for medical research and drug development (Desirable)

    • Skills

    Clinical Trial DocumentationDatabase SoftwareExcelFile ManagementISO/IEC 17025NATAOECD GLPPowerPointTechnical WritingWord

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