The Associate Editor will work with more senior Medical Writing Editors and Medical Writers to learn about clinical regulatory documents and the drug development process. The individual will also work with more senior Medical Writing Editors to learn how to perform a full QC check of clinical regulatory documents, to ensure that they meet company standards and Health Authority guidelines. As the individual’s QC skills, knowledge of the drug development process and knowledge of regulatory document content increase, his/her responsibilities will increase to include more editing responsibilities (eg, checks for appropriate spelling/grammar, template use, and content).The Associate Editor will focus on learning QC techniques before learning the editing processes. The individual in this position will perform the following tasks:
- QC checks on Clinical Study Protocols and Clinical Study Protocol Amendments,
- This includes verifying consistency between the schedule of assessments and study description, ensuring consistency between the study schema and the schedule of events, and verifying references
- QC checks on Clinical Study Reports and Clinical Summaries,
- This includes verifying consistency between hand-generated in-text tables and source tables, and between in-text numbers/ statements and source tables; ensuring consistency between discussion/ conclusion sections and results sections; and verifying reference, table, figure, and listing citations.
- QC checks on IBs and IB Updates,
- This includes verifying consistency between hand-generated in-text tables and source tables, in-text numbers and source tables, in-text clinical summaries and Clinical Study Reports, and in-text non-clinical summaries and nonclinical reports
- Compilation, verification of content, formatting, and tracking of CSR appendices