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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing Life Sciences localization programs, ensuring compliance with regulatory standards and delivering high-quality service through effective program management and cross-functional collaboration. Proficient in implementing workflows and processes that meet stringent SLAs while driving continuous improvement and audit readiness.
Highest-signal resume keywords
Life Sciences Localization ManagementRisk Management, RCA, and CAPA ProceduresLinguistic Validation WorkflowsRegulatory Compliance KnowledgeClient-Facing Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Program ManagementService Delivery StrategiesProduction Workflow ImplementationPerformance Monitoring Against KPIsAudit-Ready DocumentationQuality Standards KnowledgeRegulatory ReviewQuotation ProductionContinuous Improvement ProcessesTraceability Maintenance
Soft Skills
Excellent Communication SkillsOrganizational SkillsAttention to DetailAnalytical Problem SolvingAbility to Work Under Pressure
Industry Keywords
Life SciencesPharmaceuticalBiotechCROMedical DeviceISO 17100ISO 13485ICH GCPEU MDR/IVDR21 CFR Part 11
About the role
Key responsibilities & impact- Provide successful Program Management for a portfolio of complex accounts
- Implement and maintain service delivery strategies to meet SLAs and desired business outcomes
- Drive cross-functional and multi-stakeholder initiatives internally and externally
- Produce competitive and well-reasoned quotations for Life Sciences services, including linguistic validation, back translation/reconciliation, regulatory review, and certified translation
- Drive implementation, testing, and iteration of complex technical production workflows with Solutions and Product
- Monitor and control production team performance against KPIs
- Direct production resources to meet and exceed KPIs and customer SLAs
- Report on production metrics and performance against objectives, explaining trends and addressing shortfalls with cross-functional action plans
- Communicate with client contacts, local colleagues, freelancers, and internal project team members
- Manage production escalations and drive RCA and CAPA to completion with audit-ready documentation
- Conduct post-mortems and plan follow-up actions for continuous improvement
- Implement processes and workflows, escalating customization or deviation requirements
- Maintain account portfolio plans and documentation for traceability and audit readiness
- Monitor and enforce production and Life Sciences-specific procedures
- Lead the account portfolio team and identify training and development opportunities
- Collaborate with Revenue and Customer Success on customer requirements and Production-specific SLAs
- Ensure regulated content follows validated processes with qualified linguists, subject-matter expert review, and full traceability
- Support client and internal quality audits
- Stay current on FDA, EMA, EU MDR/IVDR, and ICH GCP requirements and translate them into practical production requirements
Requirements
What you’ll need- 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
- Must be based in the United States
Benefits
Comp & perks- Leading tools
- Global collaboration
- Growth opportunities
- Opportunities to make a real impact