Medical Writer (Pharmaceutical)

Location: Remote

Company

hirify.global is seeking medical writing expertise to support the development and evaluation of AI-assisted clinical documentation tools.

What you will do

• Author and review Clinical Study Reports, DSURs, PSURs/PBRERs, and related regulatory documents.
• Evaluate AI-generated clinical and safety content for scientific accuracy, structure, and regulatory compliance.
• Verify narrative claims against tables, figures, listings, clinical protocols, and source data.
• Assess document organization, cross-referencing, and eCTD requirements.
• Provide structured feedback and collaborate with project teams on evaluation standards and best practices.

Requirements

• 5+ years of regulatory medical writing experience in a sponsor, CRO, or consulting environment.
• Independent experience authoring or leading Clinical Study Reports.
• Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements.
• Ability to interpret clinical protocols, tables, figures, listings, and clinical data.
• Excellent written communication, analytical skills, and collaborative problem-solving ability.
• Advanced degree in medicine, pharmacy, life sciences, or equivalent experience.

Nice to have

• Oncology or haematology experience.

Culture & Benefits

• Remote contractor engagement.
• Opportunity to contribute to AI-assisted clinical documentation evaluation.
• Collaboration with project teams to establish regulatory writing evaluation standards.