Technical Writer (Casual)

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)