Medical Writer (Pharmaceutical)

Remotebridge; United States; Remote; USD 110,000 - 150,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory writing

CSR authoring

ICH E3

eCTD knowledge

Data interpretation

Scientific writing

Feedback skills

Education

Advanced life sciences degree

Tools

eCTD systems

Job description

# Medical Writer (Pharmaceutical)Frontier AI Lab · Remote · Full-time## Ready to see if you fit?Upload a resume once, then run an honest fit check on this role in seconds. Access is free and always will be.Sign up to check your fit## About the roleRole Title: Medical Writer (Pharmaceutical)Role Type: ContractorLocation: RemoteOur team is engaging Medical Writers / Clinical Document Authors to participate in a customer’s project focused on developing advanced AI-assisted writing tools for clinical documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.### Scope of Work• Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents to inform AI tool development.• Apply expert judgment to assess whether AI-generated content fulfills clinical template and structural requirements, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.• Evaluate scientific accuracy in narrative sections such as efficacy, safety summaries, discussion, and conclusions, distinguishing true scientific or interpretive errors from stylistic differences.• Trace narrative claims to source records—tables, figures, listings, and protocols—to verify that all assertions are appropriately supported.• Provide clear and structured written rationales for each assessment, enabling precise diagnosis and improvement of AI model behavior.• Collaborate with project leads to refine evaluation frameworks and document best practices for clinical regulatory writing in the context of AI.### Preferred Qualifications• Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.• Direct experience independently authoring or leading the authoring of full Clinical Study Reports, beyond summaries or partial contributions.• Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F, ICH E2C) and eCTD placement.• Demonstrated ability to read and interpret TFLs and protocol documents, identifying where narrative diverges from source data.• Exceptional written and verbal communication skills, especially in providing structured, actionable feedback on clinical content.• Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc), or equivalent depth of authoring experience.• Experience across multiple clinical phases and therapeutic areas; oncology and haematology expertise is especially valued.Join our customer's team and leverage your authoring expertise to help design the next generation of AI-assisted clinical documentation solutions. This high-bar role offers you the chance to shape how tomorrow's writing teams draft and review regulatory documents — through your expert input, judgment, and real-world experience.