Medical Writer

RemoteJobsOne; Amsterdam; Remote; EUR 36,000 - 73,000; Part time

Job summary

RemoteJobsOne is seeking a Medical Writer (Pharmaceutical) for a fully remote contractor role open to candidates based in the Netherlands. The position focuses on developing AI-assisted clinical documentation support, requiring expertise in regulatory writing and CSR authoring.

You will author and review Clinical Study Reports, assess adherence to ICH E3 conventions, and provide clear, structured rationales tied to source data. Collaboration with project leads is essential.

Qualifications

• Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
• 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.

Responsibilities

• Author and review Clinical Study Reports and related regulatory documents to inform AI tool development.
• Assess AI-generated content for compliance with clinical template structure, ICH guidelines, and cross-referencing.
• Evaluate scientific accuracy in narrative sections and distinguish true errors from stylistic differences.
• Trace narrative claims to source records (tables, figures, listings, protocols).
• Provide clear, structured rationales to support assessments and improvements of AI model outputs.
• Collaborate with project leads to refine evaluation frameworks and document best practices for regulatory writing in AI context.

Skills

Regulatory medical writing

CSR authoring

ICH E3 E2F E2C knowledge

Reading and interpreting protocols

Structured, actionable feedback

Clinical phases experience

Oncology/haematology domain knowledge

Education

Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc)

Job description

IMPORTANT: after you apply, please check your email. We send you a link to complete your application — it is not considered until that last step is done. If you do not see it, check your spam folder.

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

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.