Medical Writing Specialist - Generative AI

Faro Health Inc.; California; Remote; USD 100,000 - 125,000; Full time

Job summary

An innovative company is seeking a Medical Writing Specialist to enhance its AI-driven protocol authoring solution. This role is pivotal in ensuring that AI-generated content meets high standards of quality and clarity. You will leverage your expertise in medical writing and regulatory documentation to shape the future of clinical trial documentation. Collaborating with cross-functional teams, you will set benchmarks for style and consistency across therapeutic areas, directly impacting the pace of innovation in clinical development. Join a forward-thinking team and help transform the landscape of medical writing.

Qualifications

• 5+ years of experience in Clinical Operations in pharmaceutical trials.
• Strong expertise in clinical trial protocol and regulatory document writing.

Responsibilities

• Support the development of AI solutions for clinical protocol writing.
• Evaluate the quality and style of AI-generated protocol text.

Skills

Medical Writing

Scientific Communication

Regulatory Documentation

Clinical Trial Protocol Development

Attention to Detail

Team Collaboration

Emotional Intelligence

Organizational Skills

Education

Bachelor's Degree in Physical or Life Science

Tools

EDC

IRT

CTMS

ePRO

eCOA

eConsent

TMF

Job description

Faro Health aims to improve lives by helping life sciences companies answer complex clinical questions, simply, efficiently and effectively. Our software platform is used to orchestrate complex clinical development with a single source of truth. It brings words, data and teams together, empowering researchers to design more intelligent trials, master complexity and reach milestones faster.

The Medical Writing Specialist – Generative AI will play a pivotal role in shaping the future of medical writing by advancing Faro’s AI-driven protocol authoring solution. In this role, you will apply your expertise in medical writing, scientific communication, and regulatory documentation to ensure that AI-generated content meets the highest standards of clarity, quality, and scientific accuracy. You will help define what exceptional protocol writing looks like in an AI-driven world — setting the benchmark for style, consistency, and precision across a variety of therapeutic areas. Your work will directly influence how clinical research documents are crafted, accelerating the pace of innovation in clinical development and transforming how the industry approaches medical writing.

This position is remote and offers flexible work hours. Open to candidates who currently reside in California, Nevada, Wisconsin, North Carolina, Pennsylvania, Virginia or New York only.

Requirements

Duties and Responsibilities

• Serve as a subject matter expert to support the development of Faro’s generative AI solution for clinical protocol writing.
• Identify, review, and curate high-quality clinical trial protocols and associated documents to be used as examples and training data.
• Evaluate the quality, scientific content, consistency, and style of AI-generated protocol text.
• Collaborate closely with software engineers, clinical specialists, and product management teams to provide clinical and editorial feedback to enhance the AI product.
• Provide clear and structured commentary on generated outputs, identifying gaps, inconsistencies, and areas for improvement.
• Assist in the development of style guides, reference materials, and evaluation frameworks for AI-generated text.
• Support training initiatives by helping define “good vs. great” examples of clinical trial documentation for the AI to learn from.
• Contribute to the continuous improvement of model prompts and outputs by applying clinical expertise and writing best practices.

Qualifications

• Bachelor’s degree required, preferably in physical or life science or statistics discipline
• 5+ years of Clinical Operations work experience in pharmaceutical clinical trials
• Strong expertise in clinical trial protocol development, clinical study reports, and regulatory document writing.
• Ability to read and comprehend complex clinical trial protocols and designs
• Familiarity with and experience using clinical trial technologies (e.g., EDC, IRT, CTMS, ePRO, eCOA, eConsent, TMF)
• Knowledge of regulatory requirements and information governance frameworks (e.g. ICH, GCP, HIPAA, GDPR)
• Excellent team player with demonstrated track record of success in a cross-functional team environment; consistent commitment to delivering on team goals with a sense of shared urgency
• Available to work 20 - 40 hours per week (open to part-time or full-time)

Skills and Competencies

• Strong organizational, motivational, and leadership skills, promoting a team-based approach
• Strong attention to detail skills and ability to triage and aid in resolution of escalations
• Ability to work independently or in a group setting; ability to adjust to changing priorities
• Strong emotional intelligence, interpersonal and communication skills, both verbal and written
• Strong organizational and leadership skills
• Goal-oriented
• Ability to project and maintain a professional and positive attitude
• Strong ability to learn and utilize technology to execute job responsibilities
• Hourly range for this position is $50 to $100 per hour
• This is a 3 month contract with possibility for extension and must be able to work 20-40 hours per week. (we are open to part-time or full-time)
• Individual hourly pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.
• Open to candidates who currently reside in California, Nevada, Wisconsin, North Carolina, Pennsylvania, Virginia and New York only.