Principal Medical Writing Lead

This is a fully remote position, open to applicants in California, +3 more states.

📋 Description

• Assist in the design of Faro's medical writing product aimed at generating, reviewing, and maintaining clinical trial documents derived from structured study design data.

• Act as the medical writing representative in product development by converting authoring workflows, review processes, regulatory requirements, and writer challenges into product strategies.

• Develop quality standards and review methodologies for AI-generated content, focusing on scientific accuracy, consistency, traceability, narrative quality, and expert evaluation.

• Oversee the medical writing quality assessment framework, which includes datasets, metrics, acceptance standards, failure-mode analysis, and comparisons with documents authored by experts.

• Specify content logic and authoring guidelines for converting structured study data into regulatory-compliant narratives.

• Collaborate with selected clients to implement authoring workflows, recognize value, and facilitate the adoption of human-in-the-loop processes.

• Partner with Implementation Services and Customer Strategy during pilot projects and translate field insights into reusable product features.

• Assist in customer and commercial discussions regarding enhancements in medical authoring with AI while maintaining quality and trust.

• Identify opportunities to simplify, automate, or eliminate medical writing tasks while retaining critical scientific and regulatory judgment.

⛳️ Requirements

• A minimum of 7 years of medical writing experience within pharmaceutical, biotechnology, or CRO settings.

• Significant experience in managing complex clinical and regulatory documents.

• Extensive background in authoring and leading clinical trial protocols and their amendments.

• Strongly preferred experience with clinical study reports, investigator brochures, or submission materials.

• Robust understanding of clinical development and the cross-functional contributions from Medical, Clinical Operations, Biostatistics, Regulatory, Safety, and Data Management teams.

• Practical knowledge of global regulatory standards and document expectations pertinent to clinical development.

• Proven experience in leading document reviews and reconciling input from multiple contributors.

• Ability to resolve inconsistencies and convey complex scientific decisions in clear written language.

• Capability to engage directly with senior clinical and scientific stakeholders and establish trust through expertise.

• Bachelor's degree in a life science, health science, or a related field is required.

• Hands-on experience with generative AI and tools based on large language models (LLM).

• Aptitude for testing AI systems, assessing outputs, identifying failure patterns, and proposing enhancements.

• Ability to differentiate scientific judgment from routine tasks and pinpoint areas where human experts should retain control.

• Comfort with working on incomplete solutions and iterating rapidly.

• Capacity to switch between in-depth analysis and system-level workflow considerations.

• Strong communication skills with medical writers, clinicians, product managers, and engineers.

• Willingness to work directly with clients and facilitate the adoption of new workflows.

🏝️ Benefits

• Equity will be a significant part of the overall compensation package.

• Comprehensive Health Care Plan (Medical, Dental & Vision).

• Retirement Plan (401k).

• Basic Life Insurance.

• Short Term and Long Term Disability coverage.

• Paid Time Off (Flexible Vacation Policy; Paid Sick & Public Holidays Observed).

• Reimbursement for Training & Development.

• Hybrid Work Environment.

• Peer-to-peer bonus program.

• Company and departmental outings and events.

• Stock Option Plan.

• On-Premises Office Amenities, including gym access, restaurant tenant discounts, and Padel Nine (San Diego).