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FDA resumes in Raleigh, NC

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Business Development Project Management

Holly Springs, NC
... Bendamustine was subsequently acquired by Cephalon for late development and FDA approval for chronic lymphocytic leukemia indication with over $700M in annual sales; obviously a remarkable due diligence and recommendation for licensing. At Pharmacia ... - Apr 20

Data Entry Front Desk

Raleigh, NC
... duties of a clinical and developmental nature in support of multi-center clinical trials to ensure adherence to protocol, FDA, and international guidelines, and to ensure the quality of data received during the start up and maintenance phases of ... - Apr 11

Creative Project Manager

Central Park, NC, 27701
... 2019 Whole Foods Market, Chapel Hill, NC — Signage Auditor - Produce Department ● Organic audits & adherence according to FDA standards, receiving, new hire & cross-team training 2019 - Present TG Floristry, Raleigh, NC — Consultant + Contractor ● ... - Apr 11

Quality Control Associate Ii

Apex, NC
... Participated in audits internally and with the FDA, EMA, and contractors. Experience in troubleshooting multiple HPLC, UPLC and CE-SDS assays. ASSOCIATE SCIENTIST TALECRIS BIOTHERAPEUTICS JUL 2009 – FEB 2010 Triangle Park, NC Performing viral ... - Apr 08

Clinical Operations Project Manager

Garner, NC
... ·Obtained project information, analyzed data, and prepared documents for FDA regulatory submissions. ·Reviewed protocol documentation according to regulatory compliance in preparation for audit review. ·Created work instructions guide and trained ... - Apr 04

Clinical Research Project Manager

Research Triangle Park, NC, 27709
... Sponsors and Institutional Review Board (IRB) • Prepared and processed all regulatory documentation through the IRB, CTSRMC, FDA for Abbvie pre-start up study and study delivery timelines SOPs • Prepared and processed all required regulatory ... - Mar 24

Us Citizen Process Engineering

Cary, NC
... Regulatory Experience GLP, GMP, USP, FDA Natural products Purifying of any ingredients by the means of various techniques, such as extractions, filtrations, centrifugations, chromatographic and so on. Structure identification and characterization. ... - Mar 23

Risk Management Operational

Raleigh, NC
... Drug Safety Alliance, Raleigh, NC 11/2014 – 06/2015 Contract HR Specialist (Contract Completed) Conducted extensive internal record audits to analyze FDA compliance metrics, aligning organizational goals with strategic plan. Assured that vendor ... - Mar 18

Clinical Research Coordinator

Apex, NC
... Operating within the scope of EU Guidance on Good Manufacturing Practice, OSHA, and FDA cGMP 21CFR. Education Healthcare Clinical Research 2022 Wake Tech CC Advanced Emergency Medical Technician 2019 Nash CC I completed the 3-month hybrid course ... - Mar 07

Customer Service, Clinical Research, Trial Master File Specialist

Durham, NC
... of essential study and program documents Direct communication with CRO teams and third-party vendors Review new and revised FDA 1572s ICF review Records and compiles minutes from study team meetings Updates and maintains tracking logs FHI 360 Durham ... - Feb 22
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