- Ensures consistency and accuracy of clinical study reports, patient safety narratives, appendices, informed consent forms, clinical protocols, publications, written and tabulated summaries, amendments, and pharmacokinetic reports to source documents, templates, and client requirements.
- Proofs and edits clinical study reports, patient safety narratives, informed consent forms, clinical protocols, publications, written and tabulated summaries, amendments, and pharmacokinetic reports ensuring that company or client conventions, styles, formats, and terminology have been used.
- Completes reviews and checklists within given timelines.
- Proficient in reviewing the accuracy and consistency of high‑complexity and data‑rich documents; e.g., documents based on a trial featuring multiple criteria for evaluation, numerous unique cohorts of subjects, and/or multitude of differing endpoints.
- Compiles an electronic version of the final regulatory documents and creates the associated PDF files.
- Performs bookmarking and hyperlinking of the final PDF of the regulatory documents prior to client receipt.
- Compiles informational clinical study report appendices and inserts clinical study report tables, figures, and listings into appropriate sections.
- Performs peer review QC for published and compiled documents.
- Ensures documents are in compliance with the relevant regulatory guidelines.
- Manages, delegates, and leads team reviews.
- Understands the task to be completed and the budgeted hours. Monitors the actual hours and escalates to a manager if these hours will exceed the budgeted hours.
- Associate degree or Bachelor of Science/Arts (BS/BA) degree.
- Ability to understand and perform basic mathematical computations.
- Understanding of medical, pharmacokinetic, and statistical principles.
- Well-developed leadership skills.
- 2 years of experience
- 3 to 5 years of research experience.
- Additional experience may be substituted for education requirements.
- Must have excellent command of the English and Mandarin language, both oral and written. This includes knowledge of standard editing and proofing conventions, grammar, sentence structure, and style.
- Ability to efficiently use basic software (eg, Word, Excel, PowerPoint, Adobe Acrobat).
- High level of attention to detail and specifics.
- Knowledge of medical terminology preferred.
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