Associate Director, Nonclinical Writing AI Innovation

The Associate Director, Nonclinical Writing Innovation, will lead the strategy and adoption of AI-enabled capabilities across nonclinical workflows. This high-visibility role will translate organizational priorities into scalable digital solutions that improve productivity and efficiencies, while maintaining data integrity, and life-cycle management from data generation through regulatory documentation. The position will include, but not limited to, AI tool automation, authoring regulatory dossiers, reporting, data integrity, record retention, and Training / SOP Management. The role partners cross-functionally with scientific, technology, quality, regulatory, and business stakeholders to identify high-value use cases, operationalize AI tools, and build responsible, sustainable AI practices. Hybrid role based in Cambridge, MA, with onsite presence aligned to team and business needs.

Lead intake, prioritization, and ROI tracking for AI use cases that improve productivity and operational efficiencies. Partner with scientific, regulatory, quality, IT, InfoSec, legal, procurement, and business teams to pilot, deploy, and scale AI-enabled solutions. Accountable for nonclinical writing deliverables across many programs to improve data verification, quality, and authoring regulatory documents using AI tools. Define and execute an AI strategy and roadmap aligned with Early Development, Nonclinical Writing, and organizational innovation priorities. Champion adoption of AI, automation, and digital enablement approaches across workflows, including governance, quality control, reporting, regulatory dossiers, training, and knowledge management. Evaluate emerging technologies, enterprise AI platforms, and vendor solutions to support responsible, secure, and fit-for-purpose implementation. Establish best practices to increase productivity, data quality, reproducibility, responsible AI use, and compliance with applicable regulatory and GXP expectations. Build AI capability through training, coaching, change-champion networks, and executive-ready communications that support sustainable adoption.

Bachelor's degree in a relevant scientific field required; Master's or PhD preferred. Approximately 5–10 years of progressive experience in AI, digital transformation, technology enablement, computational life sciences, nonclinical regulatory writing, contract research organization (CRO), or related R&D environments. Demonstrated expertise in authoring a wide range of regulatory documents (eg, nonclinical study protocols and reports, IBs, regulatory submissions). Demonstrated experience translating scientific or business needs into scalable AI-enabled solutions, including use case prioritization, implementation, adoption, and value measurement. Hands-on fluency with leading AI and LLM platforms, automation capabilities, agentic AI concepts, low-code prototyping, and responsible human-in-the-loop deployment models. Strong understanding of life sciences, R&D, nonclinical electronic data systems, program management solutions, regulatory documentation workflows, and regulated or IP-sensitive operating environments. Proven ability to lead complex cross-functional initiatives without direct authority and communicate effectively with technical, scientific, operational, and senior leadership audiences. Preferred experience with enterprise AI tools, data architecture or cloud platforms, AI governance frameworks, vendor management, consulting, or change management programs. Knowledge and understanding of global health authority requirements preferred, including but not limited to, CDER/CBER, OECD, ICH guidelines, and eCTD submission requirements, and Standard for Exchange of Nonclinical Data (SEND). #LI-JR1 U.S. Pay Range $156,500.00 - $211,700.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors