Medical Writer Clinical Document Author Remote
Overview
We seek an experienced Medical Writer to develop review and evaluate clinical regulatory documents ensuring scientific accuracy and compliance. This remote contractor role focuses on authoring CSRs and supporting AI-driven documentation evaluation.
What You'll Do6
- 1Author and review Clinical Study Reports and other regulatory documents
- 2Interpret clinical protocols and ensure ICH guideline compliance
- 3Verify scientific accuracy using source data TFLs and study documentation
- 4Review safety documentation including DSURs and PSURs/PBRERs
- 5Provide structured feedback and collaborate with cross-functional teams
- 6Support AI-assisted documentation evaluation and quality improvement initiatives
Requirements5
- 15+ years of regulatory medical writing experience in a Sponsor CRO or consulting environment
- 2Experience authoring Clinical Study Reports and regulatory documentation
- 3Strong written communication and collaboration skills
- 4Advanced degree in Life Sciences Pharmacy Medicine or related field
- 5Experience in oncology and haematology is preferred
Salary Insight
$50 - $80k per year
Location
Required Skills
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