Fort Detrick, Maryland30+ days ago
The target product profiles shall contain the indication and usage, dosage and administration, dose forms and strengths, contraindications, warning and precautions, safety adverse reactions and drug interactions, use in specific populations, drug abuse and dependence/overdose, description of drug, clinical/pharmaceutical, pre-clinical toxicology, clinical studies, references, storage and handling, patient counseling, risk evaluation mitigation strategy, and supporting documentation and/or templates as appropriate. Obtain and review investigational product shipment records to track product batch, review shipping conditions, and ensure product accountability and cold chain management; Facilitate import and export of investigational product and ensure compliance with all the applicable regulations and requirements; Manage Investigational Product shipping and destruction requests and respond to investigational product requests/order forms by keeping the product accountability system up to date including but not limited to a laboratory information management system (LIMS).