Medical Writer - Clinical Development
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Job Summary
Supporting global clinical development programs, the part-time Medical Writer - Clinical Development will author, edit, and review clinical and regulatory documents while working remotely on a 4-month contract basis with flexible hours.
Key Responsibilities
- Author and review clinical and regulatory documents, including study protocols, Clinical Study Reports (CSRs), and submission materials
- Collaborate with cross-functional teams such as Clinical Development, Regulatory Affairs, and Biostatistics
- Coordinate document review cycles, integrating stakeholder feedback and ensuring timely deliverables
Required Qualifications
- 5+ years of regulatory/medical writing experience in the pharmaceutical or clinical research industry
- Hands-on experience with clinical and regulatory documents, especially protocols and CSRs
- Recent experience in Central Nervous System (CNS) clinical development programs
- Preferred experience with biologics or vaccines
- Strong knowledge of regulatory requirements and ICH guidelines
Complete Job Description
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