Role Summary
The Editor will support the Head of Medical Writing Editing and more senior Medical Writing Editors by performing a full QC check of clinical regulatory documents, to ensure that they meet company standards and Health Authority guidelines. The Editor will train on more in-depth editing techniques and be expected to perform editing duties on various document types. As the individual’s editing/QC skills, knowledge of the drug development process and knowledge of regulatory document content increase, his/her responsibilities will increase.
Responsibilities
- Work independently to perform high-quality QC checks of MW documents (e.g., Submission Modules, CSRs, IBs)
- Edit ICFs and Protocol Amendments; as knowledge and skillset improves, edit Protocols and IBs
- Train on document editing and formatting for Submission Modules and CSRs
- Work with more senior MWE staff to review and updates process improvement projects
- Compile, verify content, and format appendices for CSRs
- Ensures adherence to internal standards and procedures
Qualifications
- Required: Bachelor's Degree or editor of life science (ELS) certification
- Required: 2 years of relevant industry experience
- Required: Technical reading, writing and editing skills
- Required: Organizational, interpersonal and communication skills
- Required: Working knowledge of MS Word, Adobe Acrobat, PowerPoint
- Required: Be able to work independently
Education
- Bachelor’s Degree or editor of life science (ELS) certification