Powering the Future of Genetic Medicines
Clinical Supply Specialist – Contract
Location
United States
Posted
1 day ago
Salary
$58 - $70 / hour
Seniority
Senior
Job Description
Clinical Supply Specialist – Contract
4D Molecular Therapeutics
• Supports the development and execution of Clinical Supply strategies for all 4DMT’s Phase 1/2/3 investigational drug products and ancillaries. • Coordinate and track bulk drug orders to ensure adherence to pre-defined supply and resupply timelines. • Monitor site inventory on a daily basis; coordinate and track drug shipments to ensure uninterrupted supply. • Supports drug product inventory management and distribution in partnership with 4DMT’s clinical partners; evaluates drug utilization versus forecast considering country requirements and logistical timeline. • Maintains study and depot-level accountability and reconciliation documentation to support regulatory compliance and study closeout. • Tracks and resolves study and depot level temperature excursions. Provide routine reporting of drug wastage due to these excursions. • Archives Proof of Delivery (POD) documentation. • Maintain traceable documentation to support GXP activities. • Archives documentation on Trial Master Files as required.
Job Requirements
- Degree in biological or life sciences, pharmacy or medicine (or international equivalent).
- A minimum of 3 years in the pharmaceutical industry or relevant work experience.
- A minimum of 1 year in Clinical Supply Chain.
- Familiar in the daily management and operations of a Clinical Supply Chain inclusive of bulk management, distribution, and maintaining study blinds across multiple investigational products.
- Experienced with Interactive Response Technology - IRT systems for inventory management and resupply.
- Working knowledge of regulations relating to clinical labeling, packaging, and distribution activities; working knowledge of GMP/GCP/GLP regulations.
Benefits
- Equal employment opportunities to all employees and applicants without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
- Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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