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Regulatory Affairs Associate

Company: Stefanini
Location: Pembroke Pines
Posted on: May 8, 2022

Job Description:

Stefanini Group is hiring!Exciting opportunity awaits, let us help you get started! Click Apply now or you may call: (248) 263-5610 / email: Shaina.Pasay@stefanini.com for faster processing! Open to W2 candidates only!Required:*****Bilingual read/write in Spanish/English.***** This role would start out more as an administrative assistant type of work (filing, scanning, printing and filing, reading and compiling emails, creating documents, gathering signatures, reviewing and comparing Spanish documents). Once all of these tasks are self-managed well then I would assign and move the individual into more in-depth Regulatory work (with additional training of course) like drafting/QC ICFs/protocols, gathering/uploading documents into our eTMF cloud based repository, submitting studies to the IRB, etc.. Job Summary:The Regulatory Affairs Associate is responsible for establishing, maintaining, and providing administrative management of the Regulatory Documents in accordance with Federal regulations, ICH Guidelines, good Clinical Practices (GCPs) and WTI Standard Operating Procedures (SOPs). Essential FunctionsConducts 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 strict compliance to the study protocol at all timesGenerates, facilitates and maintains all study related regulatory documents from prestudy through study close out, ensuring quality, accuracy, and timelinessMaintains regulatory documents according to GCP, ICH, FDA, and Sponsor requirementsPrepares and maintains records for archiving and/or retrievalReviews all regulatory documents prior to Sponsor/Monitor/ Regulatory Authority visits.Works with Clinical Study Managers, clinical staff, IRB, and study Sponsors to resolve site and study related Regulatory concerns issuesProvides administrative and operational support to internal departments and clinical management teams Qualifications:Education a Bachelor's Degree in a health field is required. ExperienceProficient in MS Office (Word, Outlook, Excel and Teams)Experience organizing documents, Trial Master File preferred, in a health environmentMinimum of three (3) years of experience in the pharmaceutical industry, supporting clinical study conduct in an operational or training capacity and/or experience in a medically related profession, pharmaceutical, medical device company, or as a clinical research coordinator at an investigative site

Keywords: Stefanini, Pembroke Pines , Regulatory Affairs Associate, Other , Pembroke Pines, Florida

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