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Online Resumes with "FDA Reporting"
Professional Summary To obtain a position utilizing 33 years of nursing experience. Encompassing 15 years critical care involvement including patient care, management on the director level and 18 years in the field of cardiology, electrophysiology and research. Coordinated research studies working side by side with Investigators, handling all patient and protocol management. Publishing many abstracts and presenting results ...
SUMMARY: International work experience in Pharmacovigilance, Clinical Trials, Pharmaceutical Sales and Regulatory Affairs encompassing Phase I experimental trials through post marketing safety reporting for the National Institutes of Health and for major pharmaceutical companies. Accomplishments include: Work Instruction Manual on Data Reconciliation for Astrazeneca. Led a team of six in writing the Work Instruction Manual ...
Tags for this Online Resume: Team Lead, MedDRA, RN, Acquired Immune Deficiency Syndrome (AIDS), oncology, Drug Safety Monitoring, Quality Assurance, Quality Control, Clinical Research Support, Data Management, Pharmacovigilance, FDA Reporting, IRB, International experience, Product Launch
SUMMARY: * Accomplished Information Technology Executive Agile Release Program Manager with a verifiable track record managing complex IT Initiatives as a Senior Project Management & Program Management Professional. * Strong Experience in Agile Development, Release Management with Customer facing experience in Research and Development, Business Process improvements, Change Management, Product Launches. * Most recently led D...
Over 20 Years of experience in IT, out of which over 15 years of experience in delivering Oracle JD Edwards solution. Involved in Discover, Design and Implementations, Upgrade and Support Development of Oracle JD Edwards product. * Proficiency in advance JDE toolset Jdeveloper Business Services (BSSV's) and Real-Time Events (RTE's) along with stand JDE objects - Watchlist, E1 Pages, IOT Orchastration, Object Management Work...
I am a Regisered Nurse with interests and experience in Clinical Regional Monitoring and Clinical Management/Project Manager - 15 Years of Experience - Near 06512
I have a strong clinical background as a Registered Nurse prior to my joining the pharmaceutical industry. This has been beneficial in the course of my career. I have expertise in many areas and observational abilities in tracking subject safety and tolerability. I am aware of site challenges, having conducted clinical trials in large hospital settings as an RN and can be supportive and provide suggestions to sites when ch...
Ideal Companies: DOCs ICON Pfizer
Tags for this Online Resume: Clinical Research, Oncology, Immunology, Neuroscience, CRA, Registered Nurse, Clinical Manager, Data Management, Clinical Oversight, Project Management, CRO, CRO Oversight, GCP, ICH, Pharmaceutical Industry, Clinical Site Management, Compliance, Safety Management, Site Selection, Regulatory Compliance, Continuous Quality Improvement, Medical Writing, FDA Reporting, Trial Master File/eTMF, Cross-Functional Facilitation, Strategic Planning, Risk Analysis, Safety Oversight and Reporting, Data Targeted Review