Remote Pharma Medical Writer for AI-Regulatory Evaluation

Medcruit Limited; United States; Presencial; USD 58.000 - 115.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work

Descripción de la vacante

Appsierra Group seeks experienced Pharmaceutical Medical Writers and Clinical Document Authors to contribute to AI-assisted regulatory documentation. You will evaluate AI-generated content for scientific accuracy, regulatory structure, source-data fidelity, and appropriate clinical interpretation.

No prior AI experience is required; your expertise in pharmaceutical clinical documentation is the core requirement for this role. Remote contractor engagement with long-term project work.

Formación

• 5+ years of regulatory medical writing experience at a pharmaceutical sponsor, CRO, or as an independent consultant.
• Direct experience independently authoring or leading full Clinical Study Reports (CSRs).
• Strong knowledge of ICH E3 and conventions for periodic safety documentation, including ICH E2F and ICH E2C.
• Understanding of eCTD placement and clinical regulatory documentation conventions.
• Ability to interpret tables, figures, listings (TFLs), and clinical protocols and identify where narrative content diverges from source data.
• Exceptional written and verbal communication skills, particularly when providing structured and actionable feedback on clinical content.
• Advanced degree in life sciences, pharmacy, or medicine, such as PhD, PharmD, MD, or MSc, or equivalent depth of authoring experience.

Responsabilidades

• Author and review evaluation tasks based on Clinical Study Reports (CSRs), DSURs, PSURs/PBRERs, and related clinical documents.
• Assess AI-generated content against clinical document structures and regulatory requirements, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.
• Evaluate scientific accuracy across efficacy and safety summaries, discussion, conclusions, and other narrative sections.
• Distinguish substantive scientific or interpretive errors from acceptable stylistic differences.
• Trace narrative claims to source materials, including tables, figures, listings (TFLs), and clinical protocols, to verify that statements are appropriately supported.
• Provide clear, structured written rationales explaining assessment decisions and identified deficiencies.
• Collaborate with project leads to refine evaluation frameworks and document best practices for regulatory medical writing in AI‑assisted clinical documentation.

Conocimientos

Regulatory medical writing

Clinical Study Reports (CSRs)

ICH E3 knowledge

eCTD placement

Source data verification

Structured feedback

Educación

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

Descripción del empleo

Appsierra Group seeks experienced Pharmaceutical Medical Writers and Clinical Document Authors to contribute to AI-assisted regulatory documentation. You will evaluate AI-generated content for scientific accuracy, regulatory structure, source-data fidelity, and appropriate clinical interpretation.

No prior AI experience is required; your expertise in pharmaceutical clinical documentation is the core requirement for this role. Remote contractor engagement with long-term project work.