Regulatory Affairs Specialist II SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire, and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
Title: Regulatory Affairs Specialist IILocation: Miramar, FLIndustry: Pharmaceutical Hours: – Mon – Fri 8am – 5pmSalary: $15-$22 hour paid weekly with benefits optionsEmployment Type: 6 Long Term Contract
Environment: This client is a global leader in the Pharmaceutical industry, committed to improving the lives of patients by developing, producing and marketing affordable, high – quality generic drugs and specialty pharmaceuticals.Job Summary:The Regulatory Affairs Specialist is responsible for establishing, maintaining, andproviding administrative management of the Regulatory Documents in accordance withfederal regulations, ICH Guidelines, good Clinical Practices (GCPs) and WTI StandardOperating Procedures (SOPs).Essential Job Functions: Conducts all regulatory activities in accordance with Institutional Review Board (IRB)guidelines, Good Documentation Practices (GDPs), Good Clinical Practice (GCP)standards, Standard Operating Procedures (SOP’s), Quality procedures (QA/QC),OSHA guidelines and other state and local regulations as applicable, ensuring strictcompliance to the study protocol at all times Generates, facilitates and maintains all study related regulatory documents from pre-studythrough study close out, ensuring quality, accuracy, and timeliness Maintains regulatory documents according to GCP, ICH, FDA, and Sponsorrequirements Prepares and maintains records for archiving and/or retrieval Reviews all regulatory documents prior to Sponsor/Monitor/ Regulatory Authorityvisits. Works with Clinical Study Managers, clinical staff, IRB, and study Sponsors to resolvesite and study related Regulatory concerns issues Provides administrative and operational support to internal departments and clinicalmanagement teamsQualifications:Education a Bachelor’s Degree in a health field is required.Experience Experience organizing documents, Trial Master File preferred, in a health environment Minimum of three (3) years of experience in the pharmaceutical industry, supportingclinical study conduct in an operational or training capacity and/or experience in amedically related profession, pharmaceutical, medical device company, or as a clinicalresearch coordinator at an investigative siteADA/EOE
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