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Lilt

AI-powered multilingual translation platform for enterprises

Program Manager - Life Sciences

Program ManagementConfirmed live in the last 24 hours
Full-timeNo salary listed

About the Job

Requirements

  • At least 5 years of related experience managing Life Sciences localization programs for pharmaceutical, biotech, CRO, or medical device clients.
  • Experience with Risk Management, root cause analysis (RCA), and corrective and preventive action (CAPA) procedures in regulated Life Sciences programs and GxP environments.
  • Working knowledge of Life Sciences translation workflows, including linguistic validation through forward and back translation, reconciliation, and 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, including ISO 17100, ISO 13485, ICH GCP, EU MDR/IVDR, and 21 CFR Part 11.
  • Experience supporting client and regulatory audits and maintaining audit-ready documentation.
  • Strong client-facing and internal communication skills.
  • Organizational skills, meticulous attention to detail, and ability to multitask.
  • Analytical and organized problem-solving abilities.
  • Ability to meet deadlines and work under pressure.
  • Must be based in the United States.

Responsibilities

  • Provide successful program management for a portfolio of complex accounts.
  • Implement and maintain service delivery strategies to meet service-level agreements (SLAs) and desired business outcomes.
  • Drive cross-functional and multi-stakeholder initiatives internally and externally, collaborating with team members at every level.
  • Produce competitive, well-reasoned quotations with necessary caveats and assumptions, including scoping for Life Sciences services such as linguistic validation, back translation and reconciliation, regulatory review, and certified translation.
  • Collaborate with Solutions and Product to drive implementation, testing, and iteration of complex technical production workflows for efficiency and compliance with client standard operating procedures (SOPs) and regulatory requirements.
  • Monitor and control production team performance against key performance indicators (KPIs).
  • Direct tasks for production resources to meet and exceed KPIs and customer SLAs.
  • Report internally and externally on production metrics and performance against objectives, explain trends, and proactively address shortfalls with cross-functional action plans.
  • Communicate with client contacts, including clinical operations, regulatory affairs, and medical affairs stakeholders, as well as local colleagues, freelancers, and internal project team members.
  • Manage production escalations and drive root cause analysis (RCA) and corrective and preventive action (CAPA) to completion while maintaining audit-ready documentation aligned with GxP and client quality system requirements.
  • Conduct post-mortems on key account initiatives, share results, and plan follow-up actions with key stakeholders to support continuous improvement and learning.
  • Implement processes and workflows, escalating requirements for customizations or deviations for appropriate consideration.
  • Maintain a deep understanding of production workflows and processes related to the accounts, including Life Sciences workflows such as linguistic validation, back translation and reconciliation, and regulatory submission content.
  • Maintain current plans and documentation for the account portfolio, ensuring traceability and audit readiness.
  • Monitor and enforce adherence to production and Life Sciences-specific procedures.
  • Lead the account portfolio team and identify opportunities for training and development.
  • Collaborate with Revenue and Customer Success to ensure comprehensive customer-requirement coverage and implementation while focusing on Production-specific SLAs.
  • Ensure regulated content, including clinical trial documentation, patient-facing materials, labeling and instructions for use (IFUs), and pharmacovigilance content, follows validated processes, with qualified linguists, subject-matter expert review, and full traceability.
  • Support client and internal quality audits, keeping account processes aligned with applicable quality standards and client SOPs.
  • Stay current on regulatory requirements affecting Life Sciences translation, including FDA, EMA, EU MDR/IVDR, and ICH GCP, and translate them into practical production requirements.

About the Company

Lilt

AI-powered multilingual translation platform for enterprises

Lilt provides an AI-powered translation platform for enterprises to manage multilingual content. It uses a Contextual AI Engine with a human-in-the-loop: AI translations are reviewed by professional linguists, and feedback helps the model improve. It supports 70+ languages and formats and integrates with 100+ enterprise systems, sold as a subscription SaaS (plus direct translation services). Its goal is to speed up high-volume translation while ensuring accuracy and consistency across global content.

Company size
501-1,000
Company stage
Series C
Total funding
$95.6M
Headquarters
San Francisco, CA
Founded
2015

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