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Accountabilities:
- Serve as a subject-matter expert on global clinical and regulatory writing projects
- Lead the writing, review, and coordination of complex documents such as CTD Modules, Clinical Study Protocols, and Clinical Study Reports
- Drive development of key clinical documents that align with overall program and submission strategy
Requirements:
- Minimum 6 years of eCTD submission medical writing experience, including 3+ years as a medical writing project lead
- Extensive experience leading development of clinical summaries and regulatory submission documents across regions
- Proven ability to guide cross-functional stakeholders through complex submission development
Jobgether
Jobgether is a company that uses AI-powered matching to ensure applications are reviewed quickly, objectively, and fairly. Their system identifies the top-fitting candidates and shares this shortlist directly with the hiring company.