Life Sciences Program Manager

lilt.com; United States; Remote; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

LILT is seeking a Life Sciences Program Manager who reports to the Director, Production. You will provide successful program management for a portfolio of complex Life Sciences accounts, implementing service delivery strategies to meet SLAs and desired business outcomes.

You will drive cross-functional, multi-stakeholder initiatives with teams across client, Solutions, and Product, ensuring regulated content follows validated processes and audit-ready documentation in line with GxP requirements.

Qualifikationen

• 5+ years’ related experience managing Life Sciences localization programs for pharmaceutical, biotech, CRO or medical device clients.
• Experience in Risk Management, RCA and CAPA procedures as they apply to regulated Life Sciences programs (GxP environments).
• Working knowledge of Life Sciences translation workflows, including linguistic validation and regulated content.
• Familiarity with quality standards and regulations relevant to Life Sciences translation (ISO 17100, ISO 13485, ICH GCP, EU MDR/IVDR, 21 CFR Part 11).
• Experience supporting client and regulatory audits and maintaining audit-ready documentation.
• Excellent client-facing and internal communication skills.
• Solid organizational skills including meticulous attention to detail and multitasking skills.
• Analytical and organized problem solving abilities.
• Able to meet deadlines and work under pressure.

Aufgaben

• Provide successful Program Management for a portfolio of complex Life Sciences accounts.
• Implement and maintain service delivery strategies to meet SLAs and desired business outcomes.
• Drive cross-functional and multi-stakeholder initiatives with internal and external teams.
• Coordinate with client contacts, regulatory affairs and quality teams to ensure compliance.
• Maintain audit-ready documentation and support client/regulatory audits.
• Lead account portfolio team and identify training opportunities.

Kenntnisse

Life Sciences PM

Risk Management

Regulatory GxP

Audit Support

Client Communication

Project Management

Time Management

Analytical Thinking

Jobbeschreibung

ABOUT LILT

AI is changing how the world communicates — and LILT is leading that transformation.

We're on a mission to make the world's information accessible to everyone, regardless of the language they speak. We use cutting-edge AI, machine translation, and human-in-the-loop expertise to translate content faster, more accurately, and more cost-effectively without compromising on brand, voice, or quality.

At LILT, we empower our teammates with leading tools, global collaboration, and growth opportunities to do their best work. Our company virtues—Work together, win together; Find a way or make one; Dance in the customer's shoes; Quicker than they expect; Quality is Job 1—guide everything we do. We are trusted by Intel Corporation https://www.linkedin.com/company/intel-corporation/, Canva https://www.linkedin.com/company/canva/, the United States Department of Defense https://www.linkedin.com/company/deptofdefense/, the United States Air Force https://www.linkedin.com/company/united-states-air-force/, ASICS https://www.linkedin.com/company/asics/, and hundreds of global Enterprises. Backed by Sequoia, Intel Capital, and Redpoint, we’re building a category-defining company in a $50B+ global translation market being redefined by AI.

Location: Remote (US) or hybrid in Boston, New York or Washington, D.C. US time zone; East Coast or Central preferred.

Team: Production, Life Sciences

Reports to: Director, Production

Direct reports: US time zone project managers

THE PRODUCTION TEAM AT LILT

LILT’s Production Team is a global workforce, operating across four continents. We are passionate about localization and making information accessible to all. The Team spans project management, customer onboarding and program management, quality, and talent management, working with some of the world’s largest organizations.

Working in LILT’s Production Team you will have access to leading tools, collaborative teammates, and opportunities to make a real impact.

WHAT YOU’LL DO

The Life Sciences Program Manager reports directly to the Director, Production and is responsible for providing successful Program Management for a portfolio of complex accounts.

The Life Sciences Program Manager is responsible for implementing and maintaining successful service delivery strategies to meet SLAs and desired business outcomes.

The Life Sciences Program Manager drives cross-functional and multi-stakeholder initiatives both internally and externally, and is accomplished at collaborating with team members at every level.

KEY RESPONSIBILITIES

• Produces competitive and well reasoned quotations, with necessary caveats and assumptions, including scoping for Life Sciences services such as linguistic validation, back translation/reconciliation, regulatory review, and certified translation.
• In collaboration with Solutions and Product, will drive the implementation, testing and iteration of complex technical production workflows to ensure optimal efficiency and compliance with client SOPs and regulatory requirements.
• Demonstrates strong analytical capabilities to monitor and control production team performance against KPIs.
• Directs tasks for production resources to meet and exceed KPIs and customer SLAs.
• Regularly reports internally and externally on production metrics, performance against objectives (including KPIs and customer SLAs), explaining trends, addressing shortfalls proactively with cross-functional action plans.
• Communicates seamlessly with client contacts (including clinical operations, regulatory affairs and medical affairs stakeholders), local colleagues, freelancers and internal project team members.
• Manages production escalations, drives RCA and CAPA to completion, maintaining audit-ready documentation in line with GxP and client quality system requirements.
• Conducts post-mortems on key account initiatives, sharing results and planning follow-up actions with key stakeholders to ensure continuous improvements and learnings.
• Implementes process and workflows, escalating requirements for customizations/deviations for appropriate consideration.
• Demonstrates a deep understanding of all production workflows and processes related to their accounts, including Life Sciences-specific workflows such as linguistic validation, back translation and reconciliation, and regulatory submission content.
• Maintains up to date plans and documentation for account portfolio, ensuring traceability and audit readiness.
• Monitors and enforces adherence to production and Life Sciences-specific procedures.
• Leads the account portfolio team, identifies opportunities for training and development.
• Works in close collaboration with Revenue and Customer Success to ensure comprehensive coverage and implementation of customer requirements while focusing on Production-specific SLAs.
• Ensures regulated content (e.g., clinical trial documentation, patient-facing materials, labeling and IFUs, pharmacovigilance content) follows validated processes, with qualified linguists, subject-matter expert review and full traceability.
• Supports client and internal quality audits, keeping account processes aligned with applicable quality standards and client SOPs.
• Stays current on regulatory requirements affecting Life Sciences translation (e.g., FDA, EMA, EU MDR/IVDR, ICH GCP) and turns them into practical production requirements.

SKILLS AND EXPERIENCE

• 5+ years’ related experience managing Life Sciences localization programs for pharmaceutical, biotech, CRO or medical device clients
• Experience in Risk Management, RCA and CAPA procedures as they apply to regulated Life Sciences programs (GxP environments)
• Working knowledge of Life Sciences translation workflows, including linguistic validation (forward and back translation, reconciliation, cognitive debriefing) and regulated content such as clinical trial documentation, COAs/PROs, labeling, IFUs and regulatory submissions
• Familiarity with quality standards and regulations relevant to Life Sciences translation (e.g., ISO 17100, ISO 13485, ICH GCP, EU MDR/IVDR, 21 CFR Part 11)
• Experience supporting client and regulatory audits and maintaining audit-ready documentation
• Excellent client-facing and internal communication skills
• Solid organizational skills including meticulous attention to detail and multitasking skills
• Analytical and organized problem solving abilities
• Able to meet deadlines and work under pressure

This role requires candidates to be based in the United States.

OUR STORY

Our founders, Spence and John met at Google working on Google Translate. As researchers at Stanford and Berkeley, they both worked on language technology to make information accessible to everyone. While together at Google, they were amazed to learn that Google Translate wasn’t used for enterprise products and services inside the company.The quality just wasn’t there. So they set out to build something better. LILT was born.

LILT has been a machine learning company since its founding in 2015. At the time, machine translation didn’t meet the quality standard for enterprise translations, so LILT assembled a cutting-edge research team tasked with closing that gap. While meeting customer demand for translation services, LILT has prioritized investments in Large Language Models, human-in-the-loop systems, and now agentic AI.

With AI innovation accelerating and enterprise demand growing, the next phase of LILT’s journey is just beginning.

OUR TECH

What sets our platform apart:

• Brand-aware AI that learns your voice, tone, and terminology to ensure every translation is accurate and consistent
• Agentic AI workflows that automate the entire translation process from content ingestion to quality review to publishing
• 100+ native integrations with systems like Adobe Experience Manager, Webflow, Salesforce, GitHub, and Google Drive to simplify content translation
• Human-in-the-loop reviews via our global network of professional linguists, for high-impact content that requires expert review

LILT IN THE NEWS

• Featured in The Software Report’s https://www.thesoftwarereport.com/the-top-100-software-companies-of-2024/ Top 100 Software Companies!
• LILT makes it onto the Inc. 5000 List https://labs.lilt.com/lilt-listed-on-the-2024-inc-5000.
• LILT’s continues to be an intellectual powerhouse, holding numerous patents https://patents.justia.com/inventor/john-sturdy-denero that help power the most efficient and sophisticated AI and language models in the industry.
• Check out all our news on our website https://lilt.com/news.

Information collected and processed as part of your application process, including any job applications you choose to submit, is subject to LILT's Privacy Policy at https://lilt.com/legal/privacy.

At LILT, we are committed to a fair, inclusive, and transparent hiring process. As part of our recruitment efforts, we may use artificial intelligence (AI) and automated tools to assist in the evaluation of applications, including résumé screening, assessment scoring, and interview analysis. These tools are designed to support human decision-making and help us identify qualified candidates efficiently and objectively. All final hiring decisions are made by people. If you have any concerns, require accommodations, or would like to opt-out of the use of AI in our hiring process, please let us know at [e-mail].

LILT is an equal opportunity employer. We extend equal opportunity to all individuals without regard to an individual’s race, religion, color, national origin, ancestry, sex, sexual orientation, gender identity, age, physical or mental disability, medical condition, genetic characteristics, veteran or marital status, pregnancy, or any other classification protected by applicable local, state or federal laws. We are committed to the principles of fair employment and the elimination of all discriminatory practices.