Pharmacist
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Apply Now Application ends in 15d 17h 9min
Job Detail
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Offered Salary 0
Job Description
Key Responsibilities:
- Review and approve clinical site orders, assess clinical protocols, and calculate supply requirements.
- Coordinate product supply levels, expiration dates, and collaborate with manufacturers to ensure continuous availability.
- Engage with pharmacists, conduct site visits, handle international shipping, and support packaging processes.
- Establish and update Standard Operating Procedures (SOPs) to align with regulatory and operational standards.
- Screen, process, and approve investigational drug orders in compliance with the protocol.
- Maintain accurate records of drug quantities, product details and inventory management using COSMOS.
- Facilitate emergency shipments and ensure the timely distribution of investigational agents.
- Review pharmacy monitoring reports, conduct site audits, and work with the Project Officer on clinical site concerns.
- Serve as the primary connection for clinical site pharmacists and other partners.
- Participate in meetings with NIAID/DAIDS, manufacturers, pharmaceutical partners, and clinical research sites.
- Initiate and run product recalls, including coordinating Certificates of Analysis (CoAs) for regulatory review.
- Develop drug supply statements and maintain protocol-related documents in Veeva Vault and shared drives.
- Research and facilitate the purchasing of study products while ensuring compliance with regulations.
- Establish packaging and labeling requirements that meet global regulatory standards.
- Prepare and submit audit reports and visit summaries to DAIDS.
Required Qualifications:
- Bachelor’s Degree in Pharmacy
- proven experience in the pharmaceutical industry with expertise in clinical trials and investigational drug supply management.
- Active Maryland Pharmacy License
- Strong knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Joint Commission – Hospital Accreditation Standards, and Maryland Pharmacy Laws.
- Understanding of federal, state, and international regulations for clinical study products, including import/export requirements.
- Strong analytical, research, and problem-solving skills with attention to detail.
- Ability to manage multiple projects efficiently and work independently.
- Effective communication and teamwork skills across multidisciplinary teams.
Preferred Skills:
- Experience using COSMOS for inventory management.
- Proficiency in Microsoft Office Suite and online research tools for technical report acquisition.
- Proficiency in constructing and implementing strategies to manage clinical supply in accordance with regulations.
Work Environment & Physical Requirements:
- Must enforce to all safety protocols and use personal protective equipment (PPE) as required.
- Ability to lift and carry up to 50 lbs.
- Periodic work in walk-in freezers or refrigerated environments.
- Ability to work on a computer for up to 8 hours per day.
- Work in both laboratory and warehouse/repository settings.
- Occasional domestic and international travel (up to 5 days per year).
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Application ends in 15d 17h 9min