Pharmacist

About the position

We are seeking a highly skilled Pharmacist III to support our government contract, ensuring the effective management of products. This role involves collaborating with government clients, leading all aspects of investigational drug distribution, and maintaining compliance with regulatory requirements.

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.

Requirements

• 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.

Nice-to-haves

• 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.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount