Offer summary
Qualifications:
Bachelor's/Master's degree in biomedical or life sciences, Minimum 2 years of relevant industry experience, Prior experience in pharmaceutical or biotechnology, Basic knowledge of FDA and ICH regulations, Understanding of eCTD requirements.
Key responsabilities:
- Writes, edits, and reviews clinical documentation
- Produces and tracks clinical study reports
- Collects and organizes CSR appendices documents
- Performs quality control reviews for documentation
- Collaborates on narrative automation with the team