Senior Document Quality Reviewer
23 hours ago
Job Summary:
Parexel is seeking a skilled Senior Document Quality Reviewer to provide support for the preparation of regulatory documents through the provision of document quality checking services.
Key Responsibilities:
- Perform quality control (QC) checks, including the compilation, formatting, tabulation and pagination of documents.
- Perform editorial and format QC of documents.
- Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs, templates and style guidelines.
- Work with medical writers to plan, coordinate and execute complex QC activities.
- Consolidate QCs from multiple Document Quality Reviewers (DQRs) and provide a single output to medical writers.
Requirements:
- Experience in the pharmaceutical industry and medical writing.
- Knowledge of regulatory documents and ICH-GCP guidelines.
- Proof reading, quality control and copy editing experience essential.
- Advanced word processing skills.
- Expertise in Word for Windows, including creation and adaptation of document templates.
Education:
- Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
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