Associate Director: AI-Driven Nonclinical Writing

Alnylam Pharmaceuticals, Inc.; Cambridge, Northern (MA, KY); Hybrid; USD 150,000 - 230,000; Full time

Job summary

Alnylam Pharmaceuticals, Inc. in Cambridge, MA is seeking an Associate Director for Nonclinical Writing AI Innovation to lead AI-enabled capabilities across nonclinical workflows and regulatory documentation.

The role partners with scientific, regulatory, quality, IT, and business teams to prioritize use cases, deploy scalable AI solutions, and drive sustainable adoption with governance and data integrity in mind.

Qualifications

• Bachelor's degree in a relevant scientific field; advanced degree preferred.
• 5–10 years in AI, digital transformation, or related R&D environments.
• Experience authoring regulatory documents.
• Experience translating scientific or business needs into scalable AI-enabled solutions.
• Hands-on fluency with leading AI and LLM platforms, automation capabilities, and responsible human-in-the-loop deployment.
• Strong understanding of life sciences, regulatory workflows, and compliant operating environments.
• Ability to lead cross-functional initiatives without direct authority.
• Experience with enterprise AI tools, data architecture, cloud platforms, AI governance, or change management.
• Knowledge of global health authority requirements (CDER/CBER, OECD, ICH, eCTD, SEND).

Responsibilities

• 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.

Education

Bachelor's degree in a relevant scientific field

Master's or PhD preferred

Job description

Alnylam Pharmaceuticals, Inc. in Cambridge, MA is seeking an Associate Director for Nonclinical Writing AI Innovation to lead AI-enabled capabilities across nonclinical workflows and regulatory documentation.

The role partners with scientific, regulatory, quality, IT, and business teams to prioritize use cases, deploy scalable AI solutions, and drive sustainable adoption with governance and data integrity in mind.