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
Job details are sourced from the employer's original posting.
