Medical Writer, Clinical Documents & Regulatory Affairs
Overview
You will own the full lifecycle of clinical and regulatory documents, from drafting Clinical Study Reports (CSRs) to final submission. You will interpret ICH E3 guidelines and verify scientific accuracy against source data and TFLs. You will collaborate with cross-functional teams to deliver compliant, high-quality documents. This role also supports AI-assisted documentation evaluation, combining writing expertise with modern tools. You will work remotely with flexible hours, focusing on oncology and haematology studies.
What You'll Do7
- 1Author and review Clinical Study Reports (CSRs) and other regulatory documents.
- 2Interpret clinical protocols and ensure compliance with ICH E3 guidelines.
- 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.
- 7Ensure eCTD compliance for all regulatory submissions.
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
$104 - $166k per year
Location
Required Skills
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