Associate Director, Nonclinical Writing AI Innovation
Cambridge, Massachusetts, United States · Hybrid
$157k–$212k/yr
Senior$4.5B raised
Overview 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 priori…
Skills: AI strategy, Nonclinical writing, Regulatory documentation, Data integrity, AI tool automation
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Associate Director, Nonclinical Writing AI Innovation
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
$157k–$212k/yr
Full-time
bachelor degree, postgraduate degree
Medical coverage, Dental coverage, Vision coverage, Life insurance, Disability insurance, Lifestyle reimbursement program
Posted 8d ago
~40 hrs/week
Responsibilities
The Associate Director will lead the strategy and adoption of AI-enabled capabilities across nonclinical workflows to improve productivity and data integrity. They will partner with cross-functional teams to pilot, deploy, and scale AI solutions while ensuring compliance with regulatory and GXP expectations.
Requirements
Candidates must have a bachelor's degree in a scientific field and 5–10 years of experience in AI, digital transformation, or nonclinical regulatory writing. Expertise in authoring regulatory documents and hands-on fluency with AI and LLM platforms is required.
Full job description
Overview
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.
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.
Qualifications
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 including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).
Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers
About Alnylam
We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.
Alnylam is the leading RNAi therapeutics company. We're a fast-growing biopharma with a deep pipeline and global reach.
Industry
Biotechnology Research
Company size
1,001-5,000 employees
Founded
2002
Headquarters
Cambridge, Massachusetts
LinkedIn followers
298,456
Total funding
$4.5B
SILENCE DISEASE. AMPLIFY LIFE.™
Alnylam is a leading independent biopharmaceutical company and the pioneer in RNA interference (RNAi) therapeutics – a revolutionary approach to treating diseases which “silences” the genes that cause or contribute to them.
Founded in 2002 by a group of distinguished researchers and biotech leaders, Alnylam’s work over more than two decades has yielded the critical breakthroughs and advancements that have made the field of (RNAi) therapeutics possible. In 2018, our first commercial medicine, and the world’s first RNAi therapeutic was approved. Since then, five more Alnylam-developed medicines have been approved and we’re hard at work developing new therapies to treat both rare and prevalent diseases.
We are a global and diverse company of 2,600+ people. We pride ourselves on fostering a fun, inclusive and dynamic work environment where employees can recognize their fullest potential. That's why we’re consistently ranked as a top employer by The Boston Globe (2015-25), Science Magazine (2018-25), Fast Company (Best Workplaces for Innovators 2020-25) and Great Place to Work.
We are based in Cambridge, Massachusetts (U.S.), with offices throughout North America, Europe, Asia, and South America.
See our social media community guidelines: https://bit.ly/2FcRhJy.
Please note: If you wish to report an adverse event or product complaint, please email [email protected] or you may call us using the following telephone numbers: for North America, 877.ALNYLAM (877.256.9526), for Europe, +31 20 369 7861
Fraudulent Recruitment Activity
Be aware of the potential for scams and fraudulent recruitment activity from individuals claiming to represent Alnylam Pharmaceuticals. Alnylam never conducts its interview process via messaging apps, freelance sites, or social media platforms. Alnylam team members only communicate with potential candidates through an official Alnylam email address ending in "@alnylam.com."
Offices: 675 W Kendall St, Cambridge, Massachusetts 02142, US · 27 Market Street, Maidenhead, England SL6 8AA, GB · Grafenauweg 4, Zug, Zug 6300, CH · Antonio Vivaldistraat 150, Amsterdam, North Holland 1083, NL · Erika-Mann-Str. 7, Munich, Bavaria 80636, DE
How much do Data & Analytics jobs in Cambridge, MA pay?
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