Clinical Regulatory Affairs Specialist – Level 2
PCI Pharma Services
full-time
Posted on:
Location Type: Office
Location: Rockford • Illinois • 🇺🇸 United States
Visit company websiteSalary
💰 $69,920 - $78,660 per year
Job Level
Mid-LevelSenior
About the role
- 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.
Requirements
- 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.
- High Standard of Report Writing
Benefits
- paid time off
- health insurance coverage (including dental and vision)
- flexible spending account
- 401(k)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
audit managementregulatory compliancereport writingdata analysisinventory managementcorrective action developmentquality assuranceinvestigation reviewregistration application preparationClinical Customer Quality Agreements
Soft skills
problem solvingcommunicationorganizational skillsattention to detailteam collaborationleadershippresentation skillscritical thinkingadaptabilityinterpersonal skills