Director Medical Writing - AI Document Lead
Verastem Oncology
June 30, 2026
Remote friendly (Greater Boston)
United States
Clinical Research and Development
Position Summary
- Experienced medical writer with expertise in clinical and regulatory documents and demonstrated use of AI-enabled tools to support development, review, and QC of clinical documentation.
Key Responsibilities
- Author, edit, and manage clinical and regulatory documents (protocols, CSRs, IBs, amendments, clinical summaries, and submission-supporting materials).
- Use AI-enabled tools for drafting, summarization, content reuse, consistency checks, and document QC; verify outputs against approved source materials.
- Develop and refine human-in-the-loop workflows for AI-assisted medical writing (prompt strategies, source mapping, review checkpoints, quality controls).
- Partner cross-functionally (Clinical Development/Operations, Regulatory Affairs, Safety, Biostatistics, Data Management, others) to ensure documents are scientifically accurate, submission-ready, and aligned to program strategy.
- Improve efficiency via templates, libraries, automation, structured content, and cross-document consistency.
- Ensure AI-assisted outputs comply with applicable SOPs, GCP, ICH, regulatory expectations, confidentiality, and internal governance.
- Support review/adjudication of cross-functional comments with traceability and final content quality.
- Contribute to best practices, training, and governance for responsible AI use.
Required Qualifications
- Significant experience authoring clinical/regulatory documents (protocols, CSRs, IBs).
- Strong knowledge of clinical development, GCP, ICH, and regulatory document standards.
- Demonstrated AI/automation/structured content/advanced document-generation experience.
- Ability to critically evaluate AI-generated content for scientific and regulatory accuracy, source alignment, and completeness.
- Strong project management; ability to manage complex documents, timelines, review cycles, and stakeholders.
- Excellent written and verbal communication.
Preferred Qualifications
- Experience building AI-assisted workflows (prompt libraries, templates, content reuse, QC frameworks).
- Experience with LLMs, document intelligence platforms, structured authoring, literature automation, or medical writing tech.
- Oncology/rare disease experience.
- Regulatory submission experience.
- Familiarity with data privacy/security/validation/governance for AI tools.
Benefits/Compensation
- Base salary range: $220,000–$260,000; eligible for annual bonus, equity compensation, and competitive benefits package.
Application Instructions
- Not specified.
- Experienced medical writer with expertise in clinical and regulatory documents and demonstrated use of AI-enabled tools to support development, review, and QC of clinical documentation.
Key Responsibilities
- Author, edit, and manage clinical and regulatory documents (protocols, CSRs, IBs, amendments, clinical summaries, and submission-supporting materials).
- Use AI-enabled tools for drafting, summarization, content reuse, consistency checks, and document QC; verify outputs against approved source materials.
- Develop and refine human-in-the-loop workflows for AI-assisted medical writing (prompt strategies, source mapping, review checkpoints, quality controls).
- Partner cross-functionally (Clinical Development/Operations, Regulatory Affairs, Safety, Biostatistics, Data Management, others) to ensure documents are scientifically accurate, submission-ready, and aligned to program strategy.
- Improve efficiency via templates, libraries, automation, structured content, and cross-document consistency.
- Ensure AI-assisted outputs comply with applicable SOPs, GCP, ICH, regulatory expectations, confidentiality, and internal governance.
- Support review/adjudication of cross-functional comments with traceability and final content quality.
- Contribute to best practices, training, and governance for responsible AI use.
Required Qualifications
- Significant experience authoring clinical/regulatory documents (protocols, CSRs, IBs).
- Strong knowledge of clinical development, GCP, ICH, and regulatory document standards.
- Demonstrated AI/automation/structured content/advanced document-generation experience.
- Ability to critically evaluate AI-generated content for scientific and regulatory accuracy, source alignment, and completeness.
- Strong project management; ability to manage complex documents, timelines, review cycles, and stakeholders.
- Excellent written and verbal communication.
Preferred Qualifications
- Experience building AI-assisted workflows (prompt libraries, templates, content reuse, QC frameworks).
- Experience with LLMs, document intelligence platforms, structured authoring, literature automation, or medical writing tech.
- Oncology/rare disease experience.
- Regulatory submission experience.
- Familiarity with data privacy/security/validation/governance for AI tools.
Benefits/Compensation
- Base salary range: $220,000–$260,000; eligible for annual bonus, equity compensation, and competitive benefits package.
Application Instructions
- Not specified.