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Online Resumes with "Regulatory Guidelines"
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
Quality Assurance Specialist - 10 Years of Experience - Near 08817
Project Summary: ARISg is a Drug Safety System which provides all the functionality required to manage adverse event reporting and adverse reaction requirements of different authorities around the world, from case entry to automatic generation of submission ready adverse event (AE) reports including CIOMS I, Med Watch 3500A and many more. ARISg is an automated distributed system. In this system data would transfer to variou...
Tags for this Online Resume: Test, Regression Testing, Management, QTP, Test Scripts, Business Requirements, Framework, Coding, Functional Testing, Java Programming Language
Director of Credit - 15 Years of Experience - Near 33158
PROFILE Accomplished global team leader with demonstrated ability to effectively meet goals through strong system, effective leadership and analytical abilities. Proven record of success in developing and implementing a risk management framework to identify, assess, monitor and manage credit risk ensuring compliance with internal policies and regulatory guidelines. Exceptional ability to lead cross-functional/ multicultural...
Tags for this Online Resume: leadership, credit risk, director of credit, credit and collection, project management, chnage management, team bulding, process improvement, Management, Risk Management, Risk Assessment, Data Management, Infrastructure, Policies and Procedures, Accounting, Acquisitions, Benefits
Clinical Research - 12 Years of Experience - Near 78254
SUMMARY OF QUALIFICATIONS * Managed Phase I -IV and observational Clinical Research Trials for HIV/AIDS, HIV Vaccine trials, HIV and Hepatitis, Infectious Diseases, Hyperlipidemia, Diabetes, Renal CKD, Secondary Hyperparathyroidism, Vitamin D Deficiency, Diabetic Nephropathy, Allergies, Asthma, and Immunology, Hepatic therapeutical area, from HBV, HCV, Fatty Liver, Cirrhosis in the Liver, medical devices. * As an inhouse mo...
Tags for this Online Resume: PEDIATRIC, Pharmaceutical, Surgical, C Programming Language, Data Entry, Hepatitis, Hepatitis C, Research, Therapy, Cardiovascular
Chief Financial Officer - 20 Years of Experience - Near 19081
Trusted and respected finance executive and Certified Public Accountant with a successful history of leading finance and accounting operations and organizations. Specifically skilled in improving financial performance, establishing and maintaining strong financial controls, and ensuring compliance with corporate and regulatory guidelines. A natural leader, with the highest level of integrity, able to influence others and b...
Tags for this Online Resume: IT, Human Resource, Planning, Budgeting and Forecasting, Financial statements, Oeprations, Balance, Balance Sheet, Cash Management, Financials, GAAP, Generally accepted accounting principles, Inventory, Magnetic Resonance Imaging (MRI)
Operations Manager - 20 Years of Experience - Near 53083
Accomplishments: * Streamlined the sanitation practices resulting in a 60% reduction in downtime caused by sanitation cycles * Worked across existing departmental lines to develop greater teamwork and common goals * Increased on time performance of the lab technicians resulting in timelier sharing of lab results Agricultural Manager - Lakeside Foods, Random Lake, WI December 2014 - May 2016 Responsibilities: * Assure timely...
Tags for this Online Resume: Accounting, Audit, Budgeting, Coaching, Communication Skills, Cost Control, Human Resources, Information Technology, Inventory, LESS, manufacturing, production, "project management", reliability, maintenance
Senior Business Development- 20 years experience- Florida- near 32127
Regional Business Manager skilled in Multi Market Management, supporting Project Development, Contractor Management, Sales Management, while assuring profitability. Over 20 years' experience in environmental facility based programs. SWS Environmental Services, Panama City Beach, FL Director of Waste Services (September 2015 - May 2017) * Communicate and work closely with Executive team to support Waste Management needs for...
Tags for this Online Resume: Accounting, Accounts Payable, Budgeting, P&L, human resources, hr, customer service, recruiter, talent acquisition, Environmental regulation, Estimator, Business Development, P&L evaluation, Trainer, Director, National Account Manager, Regional Management, Report to CEO, Multi Unit
Quality Assurance Director - 11 Years of Experience - Near 07076
SUMMARY Detail oriented and results focused professional with experience working in a global pharmaceutical company, research and development with multiple manufacturing sites and regulatory authorities worldwide. Possess clinical education, drug development and strong analytical background and solid understanding of the ICH, FDA, EMA Regulatory Guidelines as well as other regulatory body's guidelines and CMC requirements t...
Tags for this Online Resume: Good Laboratory Practices, Microsoft, Microsoft PowerPoint, Microsoft Visio, Policies and Procedures, Protocol, Quality, Quality Assurance, Research, Research and Development
Biostatatician - 18 Years of Experience - Near 07059
Experienced with IND/NDA submissions, and knowledgeable in regulatory guidelines (ICH), 21 CFR Part11 and Good Clinical Practice (GCP). * Highly experienced in clinical protocol development, experimental design, sample-size and power calculation, randomization, and study analysis planning (SAP). * Proficient in SAS/Base, SAS/Stat, SAS/Graph, SAS/Macro and SAS/ODS. * Skillful in data validation data manipulation, graph, tabl...
Tags for this Online Resume: Health Care Industry, clinical, protocol, sas, pharmaceutical, sap, ich, gcp, trial, phase, oncology
Purchasing - 20 Years of Experience - Near 48336
CAREER SUMMARY Global Purchasing and Supply Chain Professional with extensive and diverse experience in the Industrial and Manufacturing environment. Hands-on 'cradle-to-grave' management, analysis, and negotiation of billions of dollars-worth of diverse global products and services including CAPEX, Direct, and Indirect Materials, Professional Services, Production Parts & Tooling. Broad expertise in the formal negotiations ...
Tags for this Online Resume: ISO, Tooling, Quality, Quality Assurance, Acquisitions, Audit, Automotive, Budgetary, Capital Equipment, Purchasing, automotive, customer service, Commodity Manager, Purchasing Manager, Semior Buyer
Medical Scientist - 14 Years of Experience
Profile: Professional in Clinical Research with Extensive Medical Knowledge and Academic Research Experience Summary of Qualifications Clinical Research Skills * Graduated with Master Degree in Clinical Investigation Sciences, with knowledge and experience in clinical research, clinical trials design, IRB application, informed consent writing, protocol design, and data analysis. As well as knowledge in epidemiology and publ...
Tags for this Online Resume: Cardiology, Progress, Research, Cardiovascular, Medical, Consulting, Data Analysis, Pediatrics, Training, Attention to Detail
Financial Analyst - 15 Years of Experience - Near 48118
COVER LETTER: Dear Hiring Manager: This letter is to express my interest in bringing my years of finance experience within an international defense contractor and world's largest manufacturer of fiberglass to your organization. I am looking forward to assisting Blue Cross Blue Shield of Michigan in implementing cost saving policies and procedures and ensuring compliance with all corporate and regulatory guidelines. As my en...
Tags for this Online Resume: Email, Financial, Financial Industry, Financial Management, Hyperion, Management, Microsoft Office, Microsoft PowerPoint, Planning, Policies and Procedures
