Medical Writer, Clinical Documents & Regulatory Submissions
Overview
Author Clinical Study Reports and regulatory documents for AI-assisted projects. You will own the full authoring cycle, from protocol interpretation to final CSR, ensuring ICH E3 compliance. Work with cross-functional teams in a remote contract role, delivering high-quality outputs. Pay ranges $50–$80/hour based on experience and expertise.
What You'll Do6
- 1Author and review Clinical Study Reports and other regulatory documents, ensuring scientific accuracy and regulatory compliance.
- 2Interpret clinical protocols and ensure adherence to ICH guidelines, including ICH E3, ICH E2F, and ICH E2C.
- 3Verify scientific accuracy using source data, TFLs, and study documentation, flagging discrepancies.
- 4Review safety documentation, including DSURs and PSURs/PBRERs, for completeness and quality.
- 5Provide structured feedback to cross-functional teams, improving document quality and consistency.
- 6Support AI-assisted documentation evaluation, testing and refining models for accuracy and compliance.
Requirements5
- 15+ years of regulatory medical writing experience in a Sponsor, CRO, or consulting environment.
- 2Experience authoring Clinical Study Reports and regulatory documentation.
- 3Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements.
- 4Advanced degree in Life Sciences, Pharmacy, Medicine, or related field (MD, PharmD, PhD, or MSc).
- 5Experience in oncology and haematology is preferred.
Salary Insight
$50 - $80k per year
Location
Required Skills
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