About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
ACPRU Investigational Pharmacist ensures that the investigational product (IP) is received, stored, compounded/dispensed, and accounted for in the conduct of ACPRU clinical studies per the clinical study randomization schedule and dose preparation instructions. The Investigational Pharmacist, through appropriate application of USP, DEA and GCP requirements, generates SOPs and Work Instructions for ACPRU pharmacy operations.
Responsibilities
•Full supervisory responsibility for all pharmacy staff and equipment
•Maintain accurate drug accountability: Ensures IP-related clinical trial records including the receipt, preparation, retention samples, dispensing and return of IP are maintained per USP, DEA and GCP requirements. Ensure compliance to randomization schedule for blinded studies, responsible for verification of study set up. Ensure all pharmacy materials are available and of the appropriate quality and quantity throughout the execution of every study.
•Coordinates ordering, use and handling of ancillary supplies (e.g. rental pumps, infusion sets, IV fluids) for quality oversight and management in the conduct of clinical trials
•Subject matter expert for quality audits and regulatory inspections conducted at ACPRU
•Subject Matter Expert for SOPs, Work Instructions and Business Process documents pertaining to
ACPRU pharmacy operations, including procedures concerning quality assurance, security of controlled substances, and disposal of hazardous waste and drugs
•Review protocols and provide input on study-specific materials and activities that impact investigational product and ACPRU workflow in relation to compounding and dispensing. Contribute to the development of Dose Preparation Instructions and associated study records/templates. Including collaboration with Pharma Science and Device Development throughout all phases (0-4) of development at global sites.
•Ensure compliance with federal and state laws, regulations, and policies governing pharmacy operations
•Effectively communicates with ACPRU staff, AbbVie Management, and external vendors
•Point of contact to support AbbVie related efforts to improved clinical study execution as it related to compounded study drug preparation throughout all phases of development at global sites
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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