Medical Writer

RemoteJobsOne; Brussel; À distance; EUR 36 000 - 73 000; Temps partiel

Résumé du poste

RemoteJobsOne is seeking an experienced Medical Writer (Pharmaceutical) for a fully remote contractor role based in Belgium. You will contribute to AI-assisted clinical documentation and regulatory writing, shaping how models learn from high‑quality real‑world input and ensuring compliance with ICH guidelines.

This high‑caliber position requires 5+ years of regulatory medical writing, fluency with ICH E3 (and E2 series), and an advanced life sciences degree.

Qualifications

• Minimum 5 years of regulatory medical writing experience.
• Experience authoring or leading CSR documents.
• Fluency with ICH E3 and eCTD conventions.
• Ability to interpret clinical trial data and source documents.
• Strong written and verbal communication for actionable feedback.

Responsabilités

• Author and review Clinical Study Reports and related documents.
• Assess AI-generated content for regulatory template and structure conformance.
• Trace narrative claims to source records and verify support.
• Provide clear, structured rationales for assessments.
• Collaborate with project leads to refine evaluation frameworks.

Connaissances

Regulatory medical writing

ICH E3 knowledge

Structured feedback

Clinical study reporting

Analytical reasoning

Formation

Advanced degree in life sciences/medicine/pharmacy

Description du poste

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 Belgium.

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.