Director, Medical Writing – AI Document Lead

Verastem Oncology

Medical Writer specializing in clinical and regulatory documents and AI-enabled tools. Working on clinical study protocols, reports, and developing efficient workflows for documentation.

Posted 7/2/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesSenior💰 $220,000 - $260,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Author, edit, and manage clinical and regulatory documents, including protocols, CSRs, IBs, amendments, clinical summaries, and related submission-supporting materials.
Use AI-enabled tools to support drafting, summarization, content reuse, consistency checks, and document QC while ensuring all outputs are verified against approved source materials.
Develop and refine human-in-the-loop workflows for AI-assisted medical writing, including prompt strategies, source document mapping, review checkpoints, and quality controls.
Partner with Clinical Development, Clinical Operations, Regulatory Affairs, Safety, Biostatistics, Data Management, and other stakeholders to ensure documents are scientifically accurate, submission-ready, and aligned with program strategy.
Identify opportunities to improve efficiency across medical writing processes, including document templates, libraries, automation, structured content, and cross-document consistency.
Ensure AI-assisted outputs comply with applicable SOPs, GCP, ICH guidelines, regulatory expectations, confidentiality requirements, and internal governance standards.
Support review and adjudication of cross-functional comments, ensuring clear documentation of decisions, source traceability, and final content quality.
Contribute to best practices, training, and governance for responsible use of AI in clinical and regulatory medical writing.

Requirements

What you’ll need

Significant experience authoring clinical and regulatory medical writing deliverables, including protocols, clinical study reports, and investigator’s brochures.
Strong understanding of clinical development, GCP, ICH guidelines, and regulatory document standards.
Demonstrated experience using AI, automation, structured content, or advanced document-generation tools to support medical writing or clinical documentation.
Ability to critically evaluate AI-generated content for scientific accuracy, regulatory appropriateness, source alignment, and completeness.
Strong project management skills, including the ability to manage complex documents, timelines, review cycles, and stakeholder input.
Excellent written and verbal communication skills, with the ability to synthesize complex clinical and scientific information clearly and accurately.

Benefits

Comp & perks

Annual bonus
Equity compensation
Competitive benefits package

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Clinical Study ReportsProtocolsInvestigator’s BrochuresDocument AutomationStructured Content DevelopmentContent EvaluationSource Document MappingQuality Control ProcessesSubmission-Ready DocumentationRegulatory Document Standards

Soft Skills

Excellent Written CommunicationExcellent Verbal CommunicationCritical Evaluation Skills