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 LILTLILT'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 DoThe 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.
- Implements 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.
