Associate Director, Nonclinical Writing AI Innovation
Alnylam Pharmaceuticals
September 02, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities:
- Lead intake, prioritization, and ROI tracking for AI use cases to 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 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/digital enablement across workflows (governance, quality control, reporting, regulatory dossiers, training, knowledge management).
- Evaluate emerging technologies, enterprise AI platforms, and vendor solutions for responsible, secure, fit-for-purpose implementation.
- Establish best practices for productivity, data quality, reproducibility, responsible AI use, and compliance with regulatory and GXP expectations.
- Build AI capability via training, coaching, change-champion networks, and executive-ready communications.
Qualifications:
- Bachelor’s degree in a relevant scientific field required; Master’s or PhD preferred.
- ~5–10 years progressive experience in AI, digital transformation, technology enablement, computational life sciences, nonclinical regulatory writing, CRO, or related R&D.
- Expertise authoring regulatory documents (protocols/reports, IBs, regulatory submissions).
- Experience turning scientific/business needs into scalable AI-enabled solutions (use case prioritization, implementation, adoption, value measurement).
- Hands-on fluency with AI/LLM platforms, automation, agentic AI concepts, low-code prototyping, and responsible human-in-the-loop deployment.
- Strong knowledge of life sciences/R&D, nonclinical electronic data systems, regulatory documentation workflows, and regulated/IP-sensitive environments.
- Ability to lead cross-functional initiatives without direct authority and communicate effectively with technical and senior leadership audiences.
- Preferred: enterprise AI/data architecture/cloud, AI governance frameworks, vendor management, consulting, change management.
- Preferred knowledge of global health authority requirements (CDER/CBER, OECD, ICH, eCTD, SEND).
Compensation/Benefits (explicitly stated): Annual short-term incentive award and annual long-term incentive award; medical/dental/vision, life/disability, lifestyle reimbursement, FSAs/HSAs, 401(k) with company match, paid time off, wellness days, holidays, two recharge breaks; family resources and leave.
- Lead intake, prioritization, and ROI tracking for AI use cases to 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 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/digital enablement across workflows (governance, quality control, reporting, regulatory dossiers, training, knowledge management).
- Evaluate emerging technologies, enterprise AI platforms, and vendor solutions for responsible, secure, fit-for-purpose implementation.
- Establish best practices for productivity, data quality, reproducibility, responsible AI use, and compliance with regulatory and GXP expectations.
- Build AI capability via training, coaching, change-champion networks, and executive-ready communications.
Qualifications:
- Bachelor’s degree in a relevant scientific field required; Master’s or PhD preferred.
- ~5–10 years progressive experience in AI, digital transformation, technology enablement, computational life sciences, nonclinical regulatory writing, CRO, or related R&D.
- Expertise authoring regulatory documents (protocols/reports, IBs, regulatory submissions).
- Experience turning scientific/business needs into scalable AI-enabled solutions (use case prioritization, implementation, adoption, value measurement).
- Hands-on fluency with AI/LLM platforms, automation, agentic AI concepts, low-code prototyping, and responsible human-in-the-loop deployment.
- Strong knowledge of life sciences/R&D, nonclinical electronic data systems, regulatory documentation workflows, and regulated/IP-sensitive environments.
- Ability to lead cross-functional initiatives without direct authority and communicate effectively with technical and senior leadership audiences.
- Preferred: enterprise AI/data architecture/cloud, AI governance frameworks, vendor management, consulting, change management.
- Preferred knowledge of global health authority requirements (CDER/CBER, OECD, ICH, eCTD, SEND).
Compensation/Benefits (explicitly stated): Annual short-term incentive award and annual long-term incentive award; medical/dental/vision, life/disability, lifestyle reimbursement, FSAs/HSAs, 401(k) with company match, paid time off, wellness days, holidays, two recharge breaks; family resources and leave.