Bachelor's Degree in a related field and/or 1-5 years related experience and/or training.
Basic Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
High Standard of Report Writing
Preferred:
Ability to work independently and/or as part of a team.
Ability to demonstrate attention to detail.
Ability to identify and resolve problems in a timely manner.
Ability to hold oneself in a professional manner.
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Equal Employment Opportunity (EEO) Statement:
Benefits
Health insuranceDental insuranceVision insurance401(k)Flexible scheduleEquity / stock optionsPerformance bonus
Additional Information
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The Clinical Regulatory Affairs Specialist oversees the company's policies and objectives involving matters of government and regulations, with respect to the FDA, DEA, MHRA, EEU, State of Illinois, and other regulatory agencies. This position does not have any supervisory responsibilities.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Write and implement procedures according to the current Code of Federal Regulations.
Assure that company policies are properly followed and applied by all appropriate personnel.
Facilitate the Customer and Regulatory auditing program by completing required pre-audit documentation, hosting audits, developing appropriate corrective actions documented through the audit reports and ensuring proper implementation.
Oversee regular inventories of Controlled Substances for ARCOS reporting and required inventory reports.
Review and maintain appropriate Site Master Files.
Create, review and maintain appropriate Clinical Customer Quality Agreements both globally and site specific.
Implement Corrective Actions that result from audits.
Manage and monitor Audit Corrective Actions.
Write audit responses pertaining to customer and/or internal observations.
Review investigations associated with DEA Controlled Products.
Submit applicable registration applications.
Prepare and present monthly Clinical metrics including Customer specific and overall departmental values.
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance to work is an essential function of this position
Performs other duties as assigned by Manager/Supervisor.
Pciservices · Rockford, IL