Offer summary
Qualifications:
Bachelor's/Master's degree in biomedical or life sciences, Minimum 2 years of relevant experience, Experience with clinical documentation and data, Knowledge of global regulations (FDA, ICH), Familiarity with eCTD requirements.
Key responsabilities:
- Write, edit, and review Essential Documents
- Track clinical study report patient safety narratives
- Collect documents for CSR appendices
- Conduct quality control reviews of documents
- Collaborate with narrative automation team