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Online Resumes with "FDA"
Clinical Research - 2 Years of Experience - Near 77449
HIGHLIGHTS OF QUALIFICATIONS: * RN with close to 2-years experience in clinical trials monitoring * Knowledgeable of clinical trial procedures and approval processes. * In-depth knowledge of ICH GCP guidelines and FDA regulations * Conversant with Design and Review of case report forms (CRF) * Conversant with Site Monitoring visits (PSVs, SIVs, IMVs and COVs) to meet study expectations. * Clinical and post-marketing safety ...
Tags for this Online Resume: Direct Patient Care, DRESSING CHANGES, Medical, Patient Care, Suctioning, Surgical, Wound Care, Acquired Immune Deficiency Syndrome (AIDS), HIV, Monitoring
Pharmacist - 7 Years of Experience - Near 27516
Professional Summary: A healthcare clinician with a PhD in Pharmacy and a specialty in pulmonary medicine and a master's degree in Organizational Management/Project Management seeks an opportunity to transition into clinical research in order to apply business skills with clinical skills, and FDA regulations preferably overseeing clinical research projects. My goal is to direct or coordinate clinical research projects to en...
Tags for this Online Resume: Benefits, Biomedical Industry, Insurance, Pharmacology, Research, Drug Utilization, Inventory, Medical, Medical Records, Therapy
Electromechanical Equipment Assembler - 1 Years of Experience
SUMMARY: * More than 5 years of Experience in cGMP regulated environment. * Manage control of changes, Deviations, OOSIR and CAPA * Review batch records and releases lots * Prepare and revise Standard Operating Procedure for cGMP Equipment * Work both independently and in team to finish project on-time. * Knowledge of FDA regulations and 21 CFR 210 & 211, cGMP/GLP/GDP guidelines for solid and liquid drug products.
Tags for this Online Resume: Manufacturing, Packaging, Documentation, Management, Quality, Quality Assurance, Quality Management, Test, Audit, Quality Control
Mechanical Engineer - 20 Years of Experience - Near 14424
Professional Summary: Mr. DiGrande graduated from Union College in 1980 with a Bachelor of Science degree in Mechanical Engineering. With over 35 years of engineering experience, he was awarded four United States Patents and one company secret on manufacturing process developments. Mr. DiGrande has managed engineering projects from one to over twenty specialists with budgets ranging from $2000 to $1.2 million. Mr. DiGrande ...
Tags for this Online Resume: Engineering, Mechanical Engineering, Failure Analysis, Forensic Engineering, Manufacturing, Automation, Consulting, Delphi, HVAC, Licensing, mechanical engineering, Forensics
Clinical Pharmacovigilance/Drug Safety
SUMMARY * Medical degree with over 25 year experience in clinical and drug safety surveillance setting within the pharmaceutical and Biopharmaceutical industry (Example: Amgen, Alza Corporation, Idec, Biogen Idec, Elan, Genentech, Roche, Sharing AG, Wyeth, Élan Pharmaceuticals, Actelion Pharmaceuticals) * Advance knowledge of US and international Safety regulations and Safety assessment of Marketed and Investigational drugs...
Tags for this Online Resume: Training, Data Entry, Coding, Policies and Procedures, Clinical Research, Data Management, Immunology, Management, Oncology, Query
Clinical Research
Summary of Qualifications Clinical Research Manager, Associate, Monitor, Coordinator, with over 25 years experience in the medical field and 21 years experience in clinical trials with extensive experience in the fields of Cardiology, Electrophysiology, Neurology, Urology, Autoimmune, Respiratory, Gastroenterology, Weight Loss, Diabetes, Women's Studies, Arthritis, COPD, Gynecology, Endocrinology, Rheumatology and Stem Cell...
Tags for this Online Resume: Monitoring, Protocol, Cardiovascular, Clinical Research, Management, Pharmaceutical, Research, Therapy, Audit, Data Management, Medical Device, CRA, CTM, Clinical Trials
Engineering Technician
Tags for this Online Resume: Metal coating, vacuum technologies, DAC, Lathes, Packaging, Software, Manufacturing, Support, White Papers, Apple Mac OS X, Apple MacIntosh Operating System, MCSA, Wireshark, Color management, Fiery pro certified
Clinical Research
Tags for this Online Resume: Pricing, Pharmaceutical, Oncology, Licensing, Consulting, Research, Urology, Market Access, Patient Access, Outcomes Research, Health Economics, Neuroscience, Boston, Cambridge, Pharmaceutical Administration, Device, Biotechnology, Health Technology Assessment, Marketing, Policy, clinical trials, clinical research
Clinical Research - 1 Years of Experience - Near 35806
Professional Summary: Dynamic Clinical Research Scientist with five years of international research experience. Demonstrated expertise performing research feasibility, data collection and analysis, investigative procedures verification and report preparation. Proven medical knowledge of cardiology, nephrology, emergency medicine, intensive care, endocrinology, and gastroenterology. Skilled at researching diabetes and metabo...
Tags for this Online Resume: Clinical Research • Data Management • Statistics • Drug Safety • Clinical Study Reports • Diabetics Interventions Budget Management • Clinical Operations • Regulatory Submission Documents • Protocol Preparation • QA / QC Clinical Study R, GCP, FDA, TPD Regulations FDA Regulations • Clinical Trial Monitoring • Nutritional Biochemistry • Diet / Exercise • Metabolic Disorders, Research, Monitoring, Benefits, Cancer, Clinical Research, Insulin, clinical, oncology, pharmaceutical, gcp
Senior Manager, Functional Excellence
My objectives are to work, learn, grow and gain the necessary knowledge and experience for advancement by increasing job responsibilities and applying the effort needed to succeed in a Director of Operations position.
Tags for this Online Resume: Medical, Lean Management, Six Sigma, Management, Budgeting, Quality Assurance, Project leader, Management, New Technology, Test, FDA
Clinical Quality Assurance - 20 Years of Experience - Near 27709
Tags for this Online Resume: Quality, Validation, Chemist, Scientist, FDA Regulation, Data Review
Senior Program Manager
Tags for this Online Resume: Engineering Product Development, Medical Devices Development, Program Management, FDA, PMP, Agile
