Medical Writer

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

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 customers project focused on developing advanced AI-assisted writing tools for clinical this role youll 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 recordstables figures listings and protocolsto 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 customers 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 tomorrows writing teams draft and review regulatory documents through your expert input judgment and real-world experience.

How to apply

Apply here with your profile. We will then email you a link to complete your application on the hiring platform your application is only considered once that final step is done.

Employment Type : Full Time
Experience: years
Vacancy: 1
Hourly Salary Salary: 30 - 60