Purpose of the Mission
Scientific writing consists of writing documents related to the clinical development of products to be included in registration files. The Scientific Writer is responsible for writing, reviewing and editing Clinical and/or regulatory documents, as well as the planning, coordinating of reviews and finalization of the documents to ensure on-time delivery with quality. The Scientific Writer ensures that the appropriate company and regulatory standards are followed during document preparation.
- Writing, reviewing and editing study protocols, investigator brochures, clinical study reports and other higher level scientific/regulatory documents based on clinical trial data.
- Managing the review, approval and archiving of these documents
- Being proactive to ensure an efficient process of documents development
- Experience in the writing and editing of scientific reports/clinical documents
- Experience in computer-based authoring tools (Word, Excel, PowerPoint)
- Excellent communication, organizational, and planning skills
- Prior to working with the client, a contract Scientific Writer is expected to have been trained on the following:
- ICH E6 (Good Clinical Practice)
- ICH E3 (Structure and Content of Clinical Study Reports)
- Use of Microsoft Office tools: Word, PowerPoint, Excel
- Knowledge of basic Clinical Documentation (Protocol, ICF, CSR, IB)
- Ability to work/participate in cross-functional teams
- Positive attitude
- Ability to work efficiently
- Flexible (adapting to changes within a project, i.e. changes of priorities, timelines)
- A university degree in a scientific discipline (Masters or PhD).
English : Fluent spoken and written (fluent and grammatically correct)