Life Sciences Program Manager
New
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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 zone; East Coast or Central preferred.Full-TimeManager
Salary not disclosed
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Job Details
- Experience
- 5+ years’ related experience managing Life Sciences localization programs for pharmaceutical, biotech, CRO or medical device clients
- Required Skills
- Risk Management
Requirements
- Have 5+ years of related experience managing Life Sciences localization programs for pharmaceutical, biotech, CRO, or medical device clients.
- Bring experience in risk management, RCA, and CAPA procedures for regulated Life Sciences programs in GxP environments.
- Have working knowledge of Life Sciences translation workflows, including linguistic validation, forward and back translation, reconciliation, and cognitive debriefing.
- Understand regulated content such as clinical trial documentation, COAs/PROs, labeling, IFUs, and regulatory submissions.
- Be familiar with relevant quality standards and regulations, including ISO 17100, ISO 13485, ICH GCP, EU MDR/IVDR, and 21 CFR Part 11.
- Have experience supporting client and regulatory audits and maintaining audit-ready documentation.
- Demonstrate client-facing and internal communication skills, organizational skills, attention to detail, and the ability to multitask.
- Use analytical and organized problem-solving abilities and be able to meet deadlines and work under pressure.
Responsibilities
- Produce competitive, well-reasoned quotations for Life Sciences services, including linguistic validation, back translation and reconciliation, regulatory review, and certified translation.
- Collaborate with Solutions and Product to implement, test, and iterate technical production workflows that meet efficiency, client SOP, and regulatory requirements.
- Monitor production performance against KPIs and direct production resources to meet customer SLAs.
- Report on production metrics and performance, explain trends, and address shortfalls through 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, maintaining audit-ready documentation.
- Conduct post-mortems on key account initiatives and coordinate follow-up actions and continuous improvements.
- Maintain account plans and documentation, enforce production procedures, and ensure regulated content follows validated processes with traceability.
- Support client and internal quality audits and translate current Life Sciences regulatory requirements into practical production requirements.
- Lead the account portfolio team and identify training and development opportunities.
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