Life Sciences Program Manager

LILT

1d•Hybrid

About The Position

The Life Sciences Program Manager provides program management for a portfolio of complex accounts and implements and maintains service-delivery strategies that meet SLAs and desired business outcomes. The role drives cross-functional and multi-stakeholder initiatives with internal teams and clients, and reports to the Director, Production. It leads US time zone project managers and works closely with Production, Solutions, Product, Revenue, and Customer Success. The position oversees competitive quotations and scoping for Life Sciences services; implementation and iteration of technical production workflows; production performance against KPIs and customer SLAs; client communication and escalations; root cause analysis and corrective and preventive actions; audit-ready account documentation; and continuous improvement. It ensures regulated content is handled through validated processes with qualified linguists, appropriate subject-matter review, and traceability, while keeping account processes aligned with applicable standards, regulations, and client SOPs. Candidates must be based in the United States. The role may be remote in the US or hybrid in Boston, New York, or Washington, D.C., with US time zone availability; East Coast or Central is preferred.

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, and corrective and preventive action procedures as applied to regulated Life Sciences programs in GxP environments.
Working knowledge of Life Sciences translation workflows, including linguistic validation (forward and back translation, reconciliation, and cognitive debriefing) and regulated content such as clinical trial documentation, COAs/PROs, labeling, instructions for use, and regulatory submissions.
Familiarity with relevant Life Sciences translation quality standards and regulations, 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.
Excellent client-facing and internal communication skills.
Solid 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

Produce competitive, well-reasoned quotations with necessary caveats and assumptions, including scoping Life Sciences services such as linguistic validation, back translation and reconciliation, regulatory review, and certified translation.
Collaborate with Solutions and Product to implement, test, and iterate complex technical production workflows for efficiency and compliance with client SOPs and regulatory requirements.
Monitor and control production team performance against KPIs, directing production resources to meet or 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 and corrective and preventive actions to completion, maintaining audit-ready documentation in line with GxP and client quality system requirements.
Conduct post-mortems on key account initiatives, share results, and plan follow-up actions with 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 account production workflows, including Life Sciences-specific workflows such as linguistic validation, back translation and reconciliation, and regulatory submission content.
Maintain current account portfolio plans and documentation to ensure traceability and audit readiness.
Monitor and enforce adherence to production and Life Sciences-specific procedures.
Lead the account portfolio team and identify training and development opportunities.
Collaborate with Revenue and Customer Success to ensure comprehensive coverage and implementation of customer requirements while focusing on Production-specific SLAs.
Ensure regulated content, including clinical trial documentation, patient-facing materials, labeling, instructions for use, and pharmacovigilance content, follows validated processes with qualified linguists, subject-matter expert review, and full traceability.
Support client and internal quality audits and keep account processes aligned with applicable quality standards and client SOPs.
Stay current on regulations affecting Life Sciences translation, including FDA, EMA, EU MDR/IVDR, and ICH GCP, and translate them into practical production requirements.