CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "US FDA"

Clinical Pharmacovigilance/Drug Safety

SUMMARY * Health care professional with extensive years of experience with Pharmaceutical/Medical device industries as Medical coding and Pharmacovigilance professional in the processing and medical review/evaluation of reports related to investigational and marketed products in the following therapeutic areas: Oncology, Neurosciences, Cardiovascular, Pain/Inflammation, Rheumatology and Diagnostic products. * Responsible fo...

Tags for this Online Resume: Management, Process Improvement, Coding, Regulatory Reporting, Audit, Cardiology, Compliance, Metrics, Oncology, Data Entry

Chemist - 4 Years of Experience - Near 55401

Professional Summary Experienced Assitant Analyst aimed to grow with a leading organization that utilize my abilities to the fullest extent possible, helping me realize and develop my potential and be a part of a team that scales great heights through continuous learning process and utmost dedication. Areas of Expertise * HPLC * UPLC * GC * Dissolution * Autotitrators * UV spectrometer * pH meter * Thermocycler * ELISA, RIA...

Tags for this Online Resume: Corrective Actions, pH Meter, Root Cause Analysis, Management, Test, Water Treatment, ELISA, English Language, High Performance Liquid Chromatography (HPLC), Hindi Language

Scientist - 5 Years of Experience - Near 94706

SUMMARY: 1. Multidisciplinary background in biochemistry, biophysics, chemistry and material science: three-year UCSF School of Dentistry postdoctoral training in biochemistry / biophysics and five-year Ph.D. research training in chemistry (biointerface design and analysis). 2. Successfully led or involved projects about biomolecular expression and analysis. 3. Proven ability to lead and work with cross-functional teams fro...

Tags for this Online Resume: Research, Chemistry, Western blot, Distribution, ELISA, High Performance Liquid Chromatography (HPLC), Imaging, Microsoft Office, Pharmaceutical, Science

Quality Professional

Qualifications Skills: Regulatory Affairs/quality assurance: Projects, related skills and practice include: * Prepare and submit 510 (k) s for US FDA on Class I and Class II Medical Devices and assisted with the preparation of Class III submittals * Compile, document and submit Technical Files for Europe (CE Marking) per Medical Device Directive (MDD) * Perform monthly trending analysis * Developing quality systems plan inc...

Tags for this Online Resume: Manufacturing, Medical, Medical Devices, Risk Analysis, Documentation, Failure Analysis, ISO, Quality Assurance, Quality, Statistical Analysis

Clinical Research - 2 Years of Experience - Near 11418

SUMMARY: * 2 years of experience in the field of clinical data management, producing data review and management objects in various clinical studies and phases in daily bases. * Coding knowledge in MedDRA and WHO Drug systems, Sound knowledge in US FDA and ICH safety reporting advices * Thorough with project set up, quality assurance, data review, data analysis, database clean up and database closing using data management sy...

Tags for this Online Resume: Pricing, Protocol, Research, Data Entry, Data Management, Management, Project Planning, Quality Assurance, Services, Support

Medical Transcriptionist

Areas of Expertise * Leveraging 510 (K) PMA and expertise in US, EU, TGA and Canadian medical device regulations. * Manage Kosher/Halal records for ingredients and resale products prepare kosher/Halal applications and registration for products and manufacturing facility. * Knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807). * Knowledge of ISO 13485, ISO 14971, ISO 9001 and work...

Tags for this Online Resume: Manufacturing, Regulatory Affairs, Test, Advertising, Due Diligence, ISO, Quality Assurance, Compliance, Quality, Quality Control

Clinical Quality Assurance - 0 Years of Experience

Executive Profile Summary I have for over 25 years acquired a vast knowledge in cGMP, Quality Management Systems, and Quality & Compliance in the areas of Pharmaceutical / Biotechnology / Biologics / Chemical Product Development / Quality Assurance & Control, and Food and Chemical Industries (which includes Food & Consumer Goods), (Industrial Retail & General Manufacturing ). My detail-oriented critical thinking creative-pr...

Tags for this Online Resume: Quality, Quality Assurance, Management, Test, Consulting, Engineering, Pharmaceutical, Protocol, QA/QC, Acquired Immune Deficiency Syndrome (AIDS)