Clinical Regulatory Affairs Specialist 2

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-2 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 hosts audits for current and prospective clients.  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.
• Assists the Regulatory Affairs Manager by 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.
• Acts as a subject matter expert to other internal resources for concepts within 21CFR 210 & 211 as well as the Control Substances Act.   
• Create, review and maintain appropriate Clinical Customer Quality Agreements both globally and site specific.
• Review and maintain appropriate Site Master Files.
• Manage and monitor Audit Corrective Actions.
• Write audit responses pertaining to customer and/or internal observations, and track completion of actions.
• 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.

QUALIFICATIONS:

Required:

• Bachelor's Degree in a related field and/or 5-10 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.

The base salary hiring range for this position is ($69,920 - $78,660)  plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).

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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.