Job Description
Work Schedule Standard (Mon-Fri)
Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse
Job Description Pharmacist III - CRPMC Government Contract 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.
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) .
This position offers an opportunity to contribute to critical clinical research initiatives while ensuring regulatory compliance and operational excellence. We encourage you to apply!
Compensation and Benefits The salary range estimated for this position based in Maryland is $91,700.00-$145,800.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
- 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
For more information on our benefits, please visit: Thermo Fisher Scientific
Job Tags
Holiday work, Contract work, Temporary work,