Medical Writer / Clinical Document Author (Regulatory Medical Writing)

Location: Remote

Salary: $50–$80 per hour

Company

hirify.global provides consulting services, including regulatory and clinical documentation support.

What you will do

• Author and review Clinical Study Reports and other regulatory documents.
• Interpret clinical protocols and ensure alignment with ICH guidelines.
• Verify scientific accuracy using source data, Tables, Figures, Listings, and study documentation.
• Review safety documentation, including DSURs and PSURs/PBRERs.
• Provide structured feedback and collaborate with cross-functional teams.
• Support AI-assisted documentation evaluation and quality improvement initiatives.

Requirements

• 5+ years of regulatory medical writing experience in a sponsor, CRO, or consulting environment.
• Experience authoring Clinical Study Reports and regulatory documentation.
• Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements.
• Experience with scientific accuracy assessment, source data verification, clinical protocol interpretation, and TFL analysis.
• Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field, such as MD, PharmD, PhD, or MSc.
• Strong written communication and collaboration skills.

Nice to have

• Experience in oncology and haematology.

Culture & Benefits

• Remote work arrangement.
• Contractor engagement.
• Work focused on clinical and regulatory documentation quality.