Temp - Senior Prompt/AI Engineer – Clinical Study Medical Writing

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)

About the Role:

We are seeking a Senior Prompt Engineer / AI Engineer to design, build, and deploy production-grade LLM systems that support clinical study medical writing workflows. This is a hands-on technical role focused on developing reliable, traceable, and regulation-aware AI solutions for drafting and quality control of Clinical Study Reports (CSRs), protocols, Investigator Brochures (IBs), safety narratives, and regulatory submissions.
You will architect and implement structured prompt systems, retrieval-augmented generation (RAG) pipelines, and validation layers.
Example tools include ChatGPT and custom GPTs (OpenAI); AWS services such as Amazon Bedrock (including Bedrock Agents/AgentCore) and AWS low-code workflow services; automation platforms such as n8n; orchestration frameworks like LangChain, LlamaIndex, and AutoGen; and data platforms such as Databricks for clinical data processing and integration.

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Your Contributions (include, but are not limited to):

Key Responsibilities 

• Design and implement section-aware prompt templates for efficacy, safety, methodology, and statistical interpretation 

• Build deterministic multi-step workflows separating data extraction, validation, and narrative generation 

• Develop and optimize RAG pipelines grounded in validated clinical artifacts (protocols, SAPs, TLFs, SDTM/ADaM) 

• Implement traceability mechanisms linking generated content to source tables, listings, and figures 

• Build automated guardrails and numerical consistency checks to prevent fabrication and cross-section discrepancies 

• Develop evaluation and regression testing frameworks across model and prompt versions 

• Deploy secure, scalable LLM services with logging, monitoring, and version control 

• Work directly with medical writers, clinicians, and biostatisticians to translate drafting requirements into robust AI workflows 

Required Qualifications 

• Deep understanding of LLMs and advanced structured prompting techniques 

• Demonstrated experience building and deploying LLM-powered systems in production 

• Strong Python and backend engineering skills 

• Experience designing validation frameworks for high-risk AI applications 

• Ability to work in regulated or compliance-sensitive environments 

• Strong analytical and technical problem-solving skills 

Preferred Qualifications 

• Clinical study medical writing experience (CSR, protocol, IB, regulatory submissions) 

• Experience integrating structured clinical/statistical outputs (SDTM, ADaM, TLFs) into AI workflows 

• Experience building RAG systems over regulated document corpora 

• Familiarity with AI validation practices in GxP or similar environments

Requirements:

​Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.