# Principal Medical Writing Product Lead

**Company:** [Faro Health](https://hotfix.jobs/companies/faro-health)
**Location:** Remote
**Role:** Product Management
**Salary:** $140k – $200k/yr
**Experience:** 7+ years
**Skills:** medical writing, clinical trial protocols, protocol amendments, clinical study reports, Generative AI, LLMs, regulatory writing, clinical development, quality evaluation, document review, biostatistics, clinical operations, data management, Regulatory Compliance, customer collaboration
**Posted:** 2026-08-13

> Leads the design and evaluation of an AI-enabled medical writing product for clinical trial and regulatory documents. The role combines deep protocol-writing expertise with product development, AI output assessment, customer pilots, and workflow redesign.

## Job Description

## 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.

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