Medical Writer

RemoteJobsOne; México; A distancia; MXN 748.000 - 1.495.000; Jornada completa

Descripción de la vacante

RemoteJobsOne seeks a Medical Writer (Pharmaceutical) on a contract basis to contribute to AI-assisted clinical documentation projects. You will author and review regulatory documents, ensuring alignment with ICH E3 and related safety reporting standards, drawing on at least five years of regulatory medical writing experience.

The role emphasizes high-quality, evidence-based narratives, traceability to source records, and clear rationales to guide AI model training.

Formación

• Minimum 5 years of regulatory medical writing experience.
• Fluency with ICH E3 conventions and eCTD placement.
• Experience authoring or leading Clinical Study Reports beyond summaries.

Responsabilidades

• Author and review clinical documents to inform AI tool development.
• Assess AI-generated content against ICH E3 structure and references.
• Evaluate scientific accuracy in efficacy and safety sections and flag errors.
• Trace narrative claims to source records and verify supporting data.
• Provide structured rationales to enable AI model improvement.
• Collaborate to refine evaluation frameworks for regulatory writing in AI.

Conocimientos

Regulatory medical writing

ICH E3 knowledge

Clinical Study Reports

Scientific writing

Feedback on clinical content

Educación

Advanced degree in life sciences, pharmacy, or medicine

Descripción del empleo

Pay: $30-60/hr

Role Title: Medical Writer (Pharmaceutical)

Role Type: Contractor

Location: Remote

We are 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

1. Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents to inform AI tool development.
2. 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.
3. Evaluate scientific accuracy in narrative sections such as efficacy, safety summaries, discussion, and conclusions, distinguishing true scientific or interpretive errors from stylistic differences.
4. Trace narrative claims to source records - tables, figures, listings, and protocols to verify that all assertions are appropriately supported.
5. Provide clear and structured written rationales for each assessment, enabling precise diagnosis and improvement of AI model behavior.
6. Collaborate with project leads to refine evaluation frameworks and document best practices for clinical regulatory writing in the context of AI.

Preferred Qualifications

1. Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
2. Direct experience independently authoring or leading the authoring of full Clinical Study Reports, beyond summaries or partial contributions.
3. Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F, ICH E2C) and eCTD placement.
4. Demonstrated ability to read and interpret TFLs and protocol documents, identifying where narrative diverges from source data.
5. Exceptional written and verbal communication skills, especially in providing structured, actionable feedback on clinical content.
6. Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc), or equivalent depth of authoring experience.
7. 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.