[Remote] Clinical Supply Specialist (Contract)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The Clinical Supply Specialist will work closely reputed company the Supply Chain team and cross-functional reputed company to support the development and execution of Clinical Supply strategies for investigational drug products.
Responsibilities
- Supports the development and execution of Clinical Supply strategies for reputed company 4DMT’s Phase 1/2/3 investigational drug products and ancillaries
- Coordinate and reputed company bulk drug orders to ensure adherence to reputed company-defined supply and resupply timelines
- Monitor site inventory on a daily reputed company; coordinate and reputed company 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 reputed company
- Maintains study and reputed company-level accountability and reconciliation documentation to support regulatory compliance and study closeout
- Tracks and resolves study and reputed company level temperature excursions. reputed company routine reporting of drug wastage due to these excursions
- Archives reputed company of Delivery (POD) documentation
- Maintain traceable documentation to support GXP activities
- Archives documentation on Trial Master Files as required
Skills
- 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
- reputed company 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
- Intermediate/Advanced knowledge of reputed company Suites
- Knowledge of Clinical Supply Management
- Solid written and verbal communication skills
- Excellent planning and organizational skills and the ability to work simultaneously on multiple reputed company with tight timelines
- Excellent interpersonal and communication skills
- reputed company attitude with a strong desire for reputed company learning
Benefits
- This is a remote or hybrid position.
reputed company