Medical Writer / Clinical Document Author

Micro1; India; A distancia; INR 1.800.000 - 2.600.000; A tiempo parcial

Descripción de la vacante

Cashback24x7 is seeking a Senior Medical Writer / Clinical Document Author for a remote contractor role. You will author and review Clinical Study Reports and related regulatory documents, ensuring alignment with ICH E3 conventions and eCTD placement.

Your expertise in life sciences and clinical writing will guide AI-assisted tooling development by providing structured feedback and validated source references.

Formación

• Minimum 5 years of regulatory medical writing experience.
• Experience authoring full Clinical Study Reports (CSRs) independently.
• Fluency with ICH E3 conventions and eCTD placement.

Responsabilidades

• Write and review CSRs and clinical documents for AI-assisted tool development.
• Assess AI-generated content for adherence to clinical templates and data sources.
• Provide structured rationales to support assessment judgments for model improvement.
• Collaborate to refine evaluation frameworks and best practices in regulatory writing.

Conocimientos

Regulatory writing

Clinical study reports

ICH guidelines

Scientific writing

Educación

Advanced life sciences degree

Herramientas

eCTD knowledge

Descripción del empleo

Job Description

Role Title: Medical Writer / Clinical Document Author

Role Type: Contractor

Location: Remote

micro1 is 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

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

Preferred Qualifications

• Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
• Direct 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.
• Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc), or equivalent depth of authoring experience.
• 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.