Medical Writer, Clinical Documents & Regulatory Affairs
Overview
You'll author and review Clinical Study Reports (CSRs) and regulatory documents for a remote-first clinical research team. You'll ensure scientific accuracy and compliance with ICH E3 guidelines while supporting AI-assisted documentation evaluation. Your work directly shapes submissions that reach global regulators. This role offers flexible remote work and a contract engagement with competitive pay.
What You'll Do6
- 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.
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 a 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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