Life Sciences Program Manager
New
L
LILTLife Sciences localization
Remote (US) or hybrid in Boston, New York or Washington, D.C. This role requires candidates to be based in the United States., US time zoneFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- 5+ years’ related experience managing Life Sciences localization programs
- Required Skills
- Risk Management
Requirements
- 5+ years’ related experience managing Life Sciences localization programs for pharmaceutical, biotech, CRO, or medical device clients.
- Experience with risk management, RCA, and CAPA procedures in regulated Life Sciences programs and GxP environments.
- Working knowledge of Life Sciences translation workflows, including linguistic validation, forward and back translation, reconciliation, and cognitive debriefing.
- Knowledge of regulated content such as clinical trial documentation, COAs/PROs, labeling, IFUs, and regulatory submissions.
- Familiarity with relevant 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.
- Strong client-facing and internal communication skills.
- Organizational skills, attention to detail, and ability to multitask.
- Analytical and organized problem-solving abilities.
- Ability to meet deadlines and work under pressure.
Responsibilities
- Scope Life Sciences services and produce quotations with appropriate caveats and assumptions.
- Collaborate with Solutions and Product to implement, test, and iterate technical production workflows that meet client SOPs and regulatory requirements.
- Monitor production performance against KPIs and direct resources to meet KPIs and customer SLAs.
- Report production metrics and performance, explain trends, and address shortfalls through cross-functional action plans.
- Communicate with client stakeholders, local colleagues, freelancers, and internal project teams.
- Manage production escalations and drive root cause analysis and CAPA to completion, maintaining audit-ready documentation.
- Maintain account plans and documentation, ensure traceability, and enforce production and Life Sciences-specific procedures.
- Lead the account portfolio team and identify training and development opportunities.
- Support client and internal quality audits and keep account processes aligned with applicable quality standards and client SOPs.
- Translate current Life Sciences regulatory requirements into practical production requirements.
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