Life Sciences Program Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee effective Program Management for a diverse portfolio of intricate accounts.

• Develop and uphold service delivery strategies to achieve SLAs and intended business objectives.

• Propel cross-functional and multi-stakeholder initiatives both internally and externally.

• Generate competitive and well-justified quotations for Life Sciences services, including linguistic validation, back translation/reconciliation, regulatory review, and certified translation.

• Facilitate the implementation, testing, and refinement of complex technical production workflows in collaboration with Solutions and Product teams.

• Monitor and assess production team performance against established KPIs.

• Allocate production resources effectively to meet and surpass KPIs and customer SLAs.

• Report on production metrics and performance relative to objectives, clarifying trends and addressing deficiencies with cross-functional action plans.

• Engage in communication with client contacts, local colleagues, freelancers, and internal project team members.

• Manage production escalations and drive Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA) to completion with documentation ready for audit.

• Conduct post-mortem analyses and strategize follow-up actions for ongoing improvement.

• Implement processes and workflows while escalating customization or deviation needs as necessary.

• Maintain account portfolio plans and documentation to ensure traceability and readiness for audits.

• Oversee and enforce production and Life Sciences-specific procedures.

• Lead the account portfolio team and identify opportunities for training and development.

• Collaborate with Revenue and Customer Success teams regarding customer requirements and Production-specific SLAs.

• Ensure that regulated content adheres to validated processes involving qualified linguists, subject-matter expert reviews, and complete traceability.

• Assist with client and internal quality audits.

• Remain updated on FDA, EMA, EU MDR/IVDR, and ICH GCP requirements, translating them into actionable production criteria.

⛳️ Requirements

• A minimum of 5 years of relevant experience managing Life Sciences localization programs for pharmaceutical, biotech, CRO, or medical device clients.

• Experience with Risk Management, RCA, and CAPA procedures as they pertain to regulated Life Sciences programs (GxP environments).

• Proficient understanding 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 pertinent to Life Sciences translation (e.g., ISO 17100, ISO 13485, ICH GCP, EU MDR/IVDR, 21 CFR Part 11).

• Experience in supporting client and regulatory audits while maintaining documentation that is audit-ready.

• Exceptional client-facing and internal communication skills.

• Strong organizational capabilities, including keen attention to detail and multitasking proficiency.

• Analytical mindset with organized problem-solving skills.

• Ability to meet deadlines and perform well under pressure.

• Must reside in the United States.

🏝️ Benefits

• Access to leading tools.

• Opportunities for global collaboration.

• Growth potential within the organization.

• Chance to make a significant impact.