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Online Resumes with "Regulatory Affair"
Manager - 20 Years of Experience - Near 33647
An accomplished operations and account manager in the healthcare and insurance industries. * A diverse background that includes client and vendor services implementation and project management employee training claims and call center operations system migration and testing compliance and regulatory affairs and government managed care programs (Medicaid Medicare ACA)
Tags for this Online Resume: Insurance, Billing, Benefits, Program Manager, Root Cause Analysis, Cms, Medicare, Account Manager, Audit, Call Center
Clinical Research Protocol Manager - 12 Years of Experience
Accomplished clinical research professional with progressive leadership experiences in clinical research practice, operations, and administration. Expertise in research strategy and process analytics, policy and procedures development, education, regulations and compliance, staff development, quality assurance and budget/financial management. Proven success in acquiring, evaluating, and managing multi-million dollar researc...
Tags for this Online Resume: Policies and Procedures, Protocol, Cancer, Audit, Clinical Research, Email, Infrastructure, Logistics, Oncology, clinical, phase iv, phase iii, phase ii, phase i, research, clinical trials, regulatory, compliance
Quality Engineer
Professional Summary Dedicated Operations and Quality Manager demonstrating effective leadership in all aspects of the job, excels at cutting costs and streamlining operations. Career has incorporated positions of increasing management and leadership over new product development, quality engineering, regulatory affairs, and complaint and CAPA management which is built on a foundation of clinical patient care and customer su...
Tags for this Online Resume: Quality Assurance, Engineering, Orthopedic, Orthopedics, Quality, Sales, Sourcing, ISO, Planning, Development Activities
Quality Manager
Profile: I am a Quality, Food Safety, Health & Safety as well as Environmental Management Systems practitioner and Auditor. I have a background in General and Food Biochemistry and a good working knowledge of Food Microbiology and Sustainability Standards. I am an FSPCA Preventive Controls Qualified Individual for Human Food according to the Food Safety Modernisation Act of the FDA. I have several years' experience comprisi...
Tags for this Online Resume: Training, Quality Assurance, Test, Audit, Documentation, Packaging, Regulatory Affairs, Retail, Statutory, Supply Chain
Life Scientist - 20 Years of Experience - Near 19335
Summary An experienced toxicologist with a successful track record supporting drug discovery research and development to progress biologic-based and/or small molecule drug candidate (s) through all phases of nonclinical development (Phase 1-4). Multiple successful NDA approvals, along with BLA approval for a respiratory biologic and successful IND submissions. Extensive and broad based expertise in conceptualizing and desig...
Tags for this Online Resume: Audit, Research, Test, Toxicology, Protocol, Compliance, Training, Evaluate, Medical, Medical Devices, oncology, protocol, pharmaceutical, ich, nonclinical, Regulatory Affairs, Quality Assurance, GXP
Administrative Assistant - 20 Years of Experience - Near 30308
Highly motivated person with extensive administrative experience in Finance, Purchasing, Information Systems and Health Care, pursuing a career that uses current skill set while providing opportunities for growth.
Tags for this Online Resume: Regulatory Affairs, Administrative Assistant, Audit, ISO, ISO 9001, Logistics, Quality Assurance, Test, Management, Sales Force Automation
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
Life Scientist - 20 Years of Experience - Near 19335
Summary An experienced toxicologist with a successful track record supporting drug discovery research and development to progress biologic-based and/or small molecule drug candidate (s) through all phases of nonclinical development (Phase 1-4). Multiple successful NDA approvals, along with BLA approval and successful IND submissions. Extensive and broad based expertise in conceptualizing and designing nonclinical developmen...
Tags for this Online Resume: Audit, Research, Test, Toxicology, Protocol, Compliance, Training, Evaluate, Medical, Medical Devices
Clinical Regulatory Affairs - 20 Years of Experience - Near 21769
Regulatory Affairs for IVD companies.
Tags for this Online Resume: gcp, clinical, protocol, oncology, phase, Genotyping, High Performance Liquid Chromatography (HPLC), Business Development, Cancer, Chemistry, Regulatory Affairs
Supervisor
Tags for this Online Resume: Distribution, Computer Aided Software Engineering, Data Management, Documentation, Email, Management, Microsoft Outlook, Regulatory Affairs, Regulatory Reporting, Triage
Lawyer - 20 Years of Experience - Near 63113
PROFESSIONAL SUMMARY Attorney offers the following: * Skilled in the development of innovative problem solving and finding unique theories, ideas, and solutions to create effectual case arguments. * Background includes legal document review and work as a solo practitioner. AREAS OF EXPERTISE COURT PROCEDURES * Developed detailed litigation strategies for each case. * Presented and summarized cases to both judges and juries....
Tags for this Online Resume: Litigation, Document Review, Complaints, Legal, Compliance, Research, Regulatory Affairs, Communication Skills, Computer Aided Software Engineering, Drafting
Lawyer
EXECUTIVE PROFILE Experienced General Counsel with broad-based legal background, strong business acumen, and demonstrated record of high performance in rapidly changing Fortune 500/100 environments. Seventeen years as General Counsel, Deputy General Counsel and senior legal advisor, and seven years as a corporate attorney with international law firms. From 2003 - 2006, was Vice President, Deputy General Counsel and Assistan...
Tags for this Online Resume: Banking Industry, Budgeting, HVAC, Management, Novell Netware, Operating Budget, Real Estate, Residential Electrical, Services, Regulatory Affairs
