Principal Medical Writing Product Lead

Responsibilities

• Help design an AI-enabled medical writing product for generating, reviewing, and maintaining clinical trial documents from structured study design data.
• Translate medical writing workflows, review cycles, regulatory expectations, and writer pain points into product decisions.
• Define quality criteria and review methods for AI-generated content, including scientific accuracy, internal consistency, traceability, narrative quality, and appropriate use of expert judgment.
• Own the medical writing quality evaluation framework, including representative datasets, quality metrics, acceptance criteria, failure-mode analysis, and comparison with expert-authored documents.
• Define content logic and authoring instructions for transforming structured study data into regulatory-grade narrative and handling study-design changes.
• Partner with selected customers during deployment of new authoring workflows and support human-in-the-loop adoption.
• Partner with Implementation Services and Customer Strategy teams during pilot engagements, distinguishing customer-specific needs from reusable product capabilities.
• Bring medical writing expertise to customer and commercial conversations about AI-enabled authoring.
• Identify work that can be simplified, automated, or removed while preserving essential scientific and regulatory judgment.

Requirements

• 7+ years of medical writing experience in pharmaceutical, biotechnology, or CRO environments, with substantial responsibility for complex clinical and regulatory documents.
• Deep experience authoring and leading the development of clinical trial protocols and protocol amendments.
• Strong understanding of clinical development and cross-functional inputs from Medical, Clinical Operations, Biostatistics, Regulatory, Safety, and Data Management.
• Practical understanding of global regulatory expectations and document standards relevant to clinical development.
• Experience leading document review and reconciliation across multiple contributors.
• Ability to resolve inconsistencies and translate complex scientific decisions into clear written content.
• Experience working directly with senior clinical and scientific stakeholders.
• Bachelor's degree in a life science, health science, or related discipline.
• Practical experience using generative AI and LLM-based tools, including evaluating outputs and identifying failure patterns.
• Ability to distinguish scientific judgment from mechanical work and identify where human expertise must remain in control.
• Strong communication, iterative problem-solving, system-level thinking, and customer collaboration skills.

Nice-to-Haves

• Experience with clinical study reports, investigator brochures, or submission content.
• Advanced scientific or clinical training.

Compensation and Benefits

• Base salary range: $140,000–$200,000.
• Equity is a major component of total compensation.
• Health care plan covering medical, dental, and vision.
• 401(k) retirement plan.
• Basic life insurance.
• Short- and long-term disability.
• Flexible vacation policy, paid sick leave, and observed public holidays.
• Training and development reimbursement.
• Hybrid work environment.
• Peer-to-peer bonus program.
• Company and department outings and events.
• Stock option plan.
• Office amenities.