Life Sciences PM - Regulated Translation Remote

Lilt; Boston, New York, Washington (MA, NY, District of Columbia); Hybrid; USD 130,000 - 190,000; Full time

Job summary

LILT is seeking a Life Sciences Program Manager to lead a portfolio of regulated translation and localization programs for pharmaceutical, biotech, CRO, or medical device clients. Based in the United States, you will drive cross-functional initiatives with regulatory and clinical stakeholders.

You\'ll define service delivery strategies, maintain audit-ready documentation, and ensure SLAs and KPIs are met while collaborating with Revenue, Customer Success, and production teams to deliver

Qualifications

• 5+ years’ experience managing Life Sciences localization programs for pharmaceutical, biotech, CRO or medical device clients.
• Experience with regulated content, such as clinical trial documentation and COAs/PROs.
• Familiarity with ISO 17100, ISO 13485, ICH GCP, EU MDR/IVDR, 21 CFR Part 11.
• Excellent client-facing and internal communication skills.

Responsibilities

• Produce quotations for Life Sciences services including linguistic validation and regulatory translation.
• Drive implementation and testing of complex production workflows with Solutions and Product.
• Monitor KPIs and ensure adherence to SLAs.
• Direct tasks for production resources to meet KPIs and SLAs.
• Report production metrics and trends to stakeholders, with action plans.
• Stays current on regulatory requirements affecting Life Sciences translation and turns them into practical production requirements.

Skills

Life Sciences program management

Regulatory compliance (GxP)

Cross-functional leadership

Client-facing communication

Risk Management RCA & CAPA

Job description

LILT is seeking a Life Sciences Program Manager to lead a portfolio of regulated translation and localization programs for pharmaceutical, biotech, CRO, or medical device clients. Based in the United States, you will drive cross-functional initiatives with regulatory and clinical stakeholders.

You\'ll define service delivery strategies, maintain audit-ready documentation, and ensure SLAs and KPIs are met while collaborating with Revenue, Customer Success, and production teams to deliver