Principal Medical Writing Product Lead

Faro Health Inc.•New York, NY

18h•$140,000 - $200,000•Hybrid

About The Position

Faro aims to improve lives by helping life sciences companies answer complex clinical questions simply, efficiently and effectively. Our software platform gives clinical development teams a single source of truth for study design, bringing structured data, documents and teams together so they can design better trials and reach important milestones faster. We are now applying AI to one of the most time consuming and consequential parts of clinical development: turning study design into high quality clinical and regulatory documents. We are looking for an experienced medical writer who wants to help build the system they always wished existed. This is not a traditional medical writing role. You will not spend your days moving from one document deadline to the next. You will use your medical writing expertise to help define how an AI enabled authoring product should work, what excellent output looks like, where expert judgment is essential, and how the workflow should change when structured study data and AI can do more of the work. You will work directly with Product, Engineering, Customer Strategy, Clinical experts and a small number of strategic customers. You will help us build and test new authoring workflows in real customer environments, learn quickly from what works and what does not, and turn those learnings into a product that can scale across the industry. Why This Role Matters Clinical trial protocols sit at the intersection of scientific intent, operational execution and regulatory communication. They are also still created through highly manual, fragmented workflows. Faro has a different starting point: our platform already represents the study design as structured data. That gives us the opportunity to rethink authoring from the underlying design forward, rather than simply placing AI on top of an existing document process. The person in this role will have meaningful influence over how that product is built. You will help decide what should be automated, how quality should be measured, how writers should interact with AI, and what a modern medical writing workflow can become. If you have spent years seeing the same inefficiencies and thinking there must be a better way, this is an opportunity to help build it.

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. Experience with additional regulatory documents such as clinical study reports, investigator brochures or submission content is strongly preferred.
Strong understanding of clinical development and the cross functional inputs required to produce a high quality protocol, including 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, including resolving inconsistencies and translating complex scientific decisions into clear written content.
Demonstrated ability to work directly with senior clinical and scientific stakeholders and earn trust through subject matter expertise.
Bachelor's degree required in a life science, health science or related discipline. Advanced scientific or clinical training is valued but not required.
You are an excellent medical writer, but you are more interested in improving how medical writing is done than preserving the current process.
You have practical experience using generative AI and LLM based tools in your work and understand both their potential and their limitations. You do not need to be an engineer, but you should be comfortable testing AI systems, evaluating outputs, identifying failure patterns, and helping determine what needs to change for the output to meet the standards of an experienced medical writer.
You can separate scientific judgment from mechanical work and explain where a human expert must remain in control.
You are comfortable working with an incomplete solution and helping make it better through fast, practical iteration.
You can move between detail and system level thinking, from reviewing a sentence for accuracy to redesigning the workflow that produced it.
You communicate clearly with medical writers, clinicians, product managers and engineers and can translate between their different perspectives.
You are comfortable working directly with customers and can listen closely, challenge assumptions constructively and help teams adopt a new way of working.

Nice To Haves

Experience with additional regulatory documents such as clinical study reports, investigator brochures or submission content is strongly preferred.
Advanced scientific or clinical training is valued but not required.

Responsibilities

Help design the medical writing product you would want to use. Bring deep practical experience to Product and Engineering as we define how Faro should generate, review and maintain clinical trial documents from structured study design data.
Serve as the medical writing voice in product development. Translate real authoring workflows, review cycles, regulatory expectations and writer pain points into clear product decisions.
Define what good looks like. Establish practical quality criteria and review methods for AI generated content, including scientific accuracy, internal consistency, traceability to source information, narrative quality and appropriate use of expert judgment.
Own the evaluation framework for medical writing quality. Define representative evaluation data sets, quality metrics and acceptance criteria for AI generated content. Test generated content, identify and categorize failure modes, compare outputs with expert authored documents, and use the results to guide product improvement.
Help define content logic and authoring instructions. Determine how structured study data should be transformed into clear regulatory grade narrative and how content should respond when the underlying study design changes.
Partner directly with selected customers as we deploy new authoring workflows. Learn how their teams work today, help identify where the greatest value can be created, and support adoption of new human in the loop ways of working.
Partnering with the Implementation Services and Customer Strategy teams during pilot engagements. Help distinguish what is customer specific from what should become reusable Faro capability. Bring field learning back to the PM and product team so successful approaches can become part of the core product.
Bring credibility to customer and commercial conversations. Speak confidently with medical writers, clinical development leaders and other stakeholders about how AI can improve the authoring process without compromising quality or trust.
Challenge the current process. We are not looking to reproduce every manual step with new technology. Help us identify work that can be simplified, automated or removed entirely while preserving the scientific and regulatory judgment that matters.