Medical Writer (Pharmaceutical)

Medical Writer (Pharmaceutical)

$57,600–$115,200/year estimated annualized equivalent
$30–$60/hour
Remote | Contractor | 30 openings

Estimated annualized equivalent based on 40 hours/week across 48 working weeks. Actual earnings vary based on hours worked, project availability, and engagement duration.

About the Role

We’re seeking experienced Pharmaceutical Medical Writers and Clinical Document Authors to contribute to the development and evaluation of AI-assisted tools for clinical and regulatory documentation.

You’ll apply hands-on regulatory medical writing expertise to realistic clinical documents and evaluation tasks, assessing AI-generated content for scientific accuracy, regulatory structure, source-data fidelity, and appropriate clinical interpretation.

No prior AI experience is required. Your experience authoring and reviewing pharmaceutical clinical documentation is the core expertise for this role.

What You’ll Do

• 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.

Requirements

• 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, beyond summaries or partial contributions.

• 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.

Preferred Qualifications

• Experience across multiple clinical development phases and therapeutic areas.

• Oncology and haematology domain expertise.

• Strong familiarity with clinical documentation workflows and source-data verification.

• Experience evaluating or documenting AI-assisted clinical or regulatory content is useful but not required.

Work & Engagement

• Remote contractor engagement

• 30 openings

• Project work focused on clinical and regulatory documentation.

• Evaluation materials may include CSRs, DSURs, PSURs/PBRERs, protocols, TFLs, and related clinical source documentation.

• Prior AI experience is not required.

Why This Opportunity

Apply your pharmaceutical medical-writing expertise to the evaluation of AI-assisted clinical documentation. The role combines regulatory writing, scientific accuracy assessment, source-data verification, clinical document interpretation, and structured expert feedback to help improve how AI handles complex pharmaceutical documentation.