Medical Writer

RemoteJobsOne; Singapore; Remote; SGD 53,000 - 106,000; Full time

Job summary

RemoteJobsOne is seeking a Medical Writer (Pharmaceutical) for a fully remote contractor role based in Singapore. You will author and review regulatory documents to train AI-assisted writing tools, applying deep domain knowledge to ensure high-quality inputs for model development.

Applicants should have 5+ years in regulatory medical writing, with experience in CSRs and strong knowledge of ICH E3 conventions and eCTD placement.

Qualifications

• Minimum 5 years of regulatory medical writing experience at sponsor/CRO or as consultant.
• Experience authoring or leading full Clinical Study Reports, not just summaries.
• Fluency with ICH E3 and safety documentation conventions (ICH E2F/E2C) and eCTD.
• Ability to read and interpret protocol documents and source data for narrative accuracy.
• Strong written and verbal feedback skills on clinical content.

Responsibilities

• Author and review tasks for CSRs, DSURs, PSURs/PBRERs to inform AI tool development.
• Assess AI content against clinical template, structure, and cross‑referencing.
• Evaluate narrative accuracy in efficacy, safety summaries, and conclusions.
• Trace narrative claims to source records and verify support.
• Provide structured written rationales to enable model improvement.
• Collaborate with leads to refine evaluation frameworks for AI‑assisted writing.

Skills

Regulatory medical writing

Clinical study reports

ICH E3 familiarity

AI-assisted clinical writing

Regulatory documentation feedback

Education

Advanced degree in life sciences, pharmacy, or medicine

Job description

This is a fully remote position, open to candidates based in Singapore.

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.