Medical Writer - Clinical Development
Job Summary
Working remotely, the Medical Writer - Clinical Development will author, edit, and review clinical and regulatory documents to support global clinical development programs on a full-time basis.
Key responsibilities
- Author clinical study protocols, Investigator Brochures, Clinical Study Reports, and regulatory submission documents
- Develop documents in accordance with regulatory requirements and internal standards while managing document review cycles
- Support regulatory submissions and health authority interactions, ensuring inspection readiness activities are met
Required qualifications
- Bachelor's degree or higher in a relevant scientific, medical, or related discipline; advanced degree preferred
- Hands-on medical writing experience within pharmaceutical, biotechnology, CRO, or clinical research environments
- Experience authoring or reviewing Clinical Study Reports, clinical study protocols, and Investigator Brochures
- Knowledge of clinical development processes and ICH guidelines, along with Good Clinical Practice (GCP) standards
- Experience supporting global clinical development programs and regulatory documentation
Complete Job Description
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