5 дней назад
Clinical Supply Specialist (Biotech)
46 200 - 75 400$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Supply Specialist (Biotech) (Clinical Drug Supply & Logistics): Managing investigational product, ancillary supply, inventory, and distribution activities for clinical studies across multiple therapeutic areas with an accent on clinical supply operations, regulatory documentation, and quality release coordination. Focus on maintaining study supply continuity, managing IRT activities and inventory risks, and supporting inspection readiness and compliant clinical trial execution.
Location: Dublin, Ireland; hybrid work model with 3 days per week in the office, including Tuesdays and Thursdays
Salary: 46,200.00–75,400.00 annually
Company
is a biotechnology company developing and commercializing medicines for serious diseases across multiple therapeutic areas.
What you will do
- Manage investigational product supply, inventory planning, distribution, accountability, reconciliation, returns, and destruction activities for clinical studies.
- Maintain clinical supply systems, including lot creation, batch status updates, inventory records, and shipment execution.
- Monitor supply risks, depot stock levels, inventory trends, temperature excursions, and IRT alerts.
- Coordinate QA/QP release, pack-and-label reconciliation, ancillary supply procurement, shipping logistics, and lot management.
- Support eTMF activities, Expected Document List creation, regulatory-compliant document management, inspection readiness, and UAT.
- Collaborate with cross-functional teams and external stakeholders across multiple therapeutic areas.
Requirements
- BS/BA degree in a related field.
- 2+ years of experience in Clinical Supplies, Quality Assurance/Regulatory, Precision Medicine, Supply Chain, Manufacturing, research, commercial biopharma, or an equivalent area.
- Knowledge of clinical drug development, clinical trial methodology, and cross-functional clinical development operations.
- Knowledge of ICH, GCP, and applicable regulatory guidelines and directives.
- Experience with investigational product distribution, inventory planning, accountability, reconciliation, returns, and destruction.
- Familiarity with IRT management, alert management, and user acceptance testing.
Culture & Benefits
- Science-driven environment focused on developing life-changing medicines.
- Inclusive workplace and equal employment opportunity commitment.
- Competitive total rewards package that may include bonuses, equity, pension or retirement benefits, insurance, paid time off, and family support benefits.
- Background checks may verify identity, right to work, and educational qualifications where required by local law.
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