Remote Medical Writer for AI-Driven Clinical Documents

Remotebridge; United States; Remote; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

Frontier AI Lab is seeking a Medical Writer (Pharmaceutical) for a remote contractor role focused on AI-assisted clinical documentation tools. You will author and review Clinical Study Reports, DSURs, PSURs, and related documents to guide AI development.

The role requires deep regulatory writing experience (CSR, ICH E3, E2F/E2C; eCTD). You will provide structured rationales, trace claims to sources, and deliver clear feedback to improve model outputs across multiple clinical phases, with

Qualifikationen

• Minimum 5 years of regulatory medical writing experience at sponsor, CRO, or as independent consultant.
• Direct experience authoring full Clinical Study Reports (CSR) beyond summaries.
• Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F/E2C) and eCTD placement.
• Ability to read and interpret TFLs and protocol documents, identifying narrative divergences from source data.
• Provide structured, actionable feedback on clinical content to guide AI model development.
• Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc) or equivalent depth of authoring experience.
• Experience across multiple clinical phases; oncology and haematology expertise valued.

Aufgaben

• Author and review realistic evaluation tasks based on CSR, DSURs, PSURs/PBRERs, and related clinical documents.
• Assess AI-generated content against clinical templates and structure (ICH E3, cross-referencing, appendix management).
• Evaluate narrative sections for scientific accuracy and distinguish true errors from stylistic differences.
• Trace narrative claims to source records (tables, figures, listings, protocols) to verify support.
• Provide clear rationales for assessments to enable model diagnosis and improvement.
• Collaborate with project leads to refine evaluation frameworks and document best practices.

Kenntnisse

Regulatory writing

CSR authoring

ICH E3

eCTD knowledge

Data interpretation

Scientific writing

Feedback skills

Ausbildung

Advanced life sciences degree

Tools

eCTD systems

Jobbeschreibung

Frontier AI Lab is seeking a Medical Writer (Pharmaceutical) for a remote contractor role focused on AI-assisted clinical documentation tools. You will author and review Clinical Study Reports, DSURs, PSURs, and related documents to guide AI development.

The role requires deep regulatory writing experience (CSR, ICH E3, E2F/E2C; eCTD). You will provide structured rationales, trace claims to sources, and deliver clear feedback to improve model outputs across multiple clinical phases, with