Clinical Document Author Remote
Job Location:
California, CA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Location: Remote
Job Type: Contractor
Pay: $50$80/hour
We are seeking an experienced Medical Writer / Clinical Document Author to develop review and evaluate clinical and regulatory documents while ensuring scientific accuracy regulatory compliance and high-quality medical writing.
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Author and review Clinical Study Reports (CSRs) and other regulatory documents.
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Interpret clinical protocols and ensure compliance with ICH guidelines.
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Verify scientific accuracy using source data TFLs (Tables Figures and Listings) and study documentation.
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Review safety documentation including DSURs and PSURs/PBRERs.
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Provide structured feedback and collaborate with cross-functional teams.
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Support AI-assisted documentation evaluation and quality improvement initiatives.
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Regulatory Medical Writing
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Clinical Study Report (CSR) Authoring
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ICH E3 Guidelines
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Scientific Accuracy Assessment
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Source Data Verification
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Clinical Protocol Interpretation
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TFL Analysis
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eCTD Knowledge
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Strong Written Communication & Collaboration
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5 years of regulatory medical writing experience in a Sponsor CRO or consulting environment.
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Experience authoring Clinical Study Reports and regulatory documentation.
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Strong knowledge of ICH E3 ICH E2F ICH E2C and eCTD requirements.
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Advanced degree in Life Sciences Pharmacy Medicine or a related field (MD PharmD PhD or MSc).
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Experience in oncology and haematology is preferred.
