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Online Resumes with "Regulatory guidelines"



Clinical Regional Monitoring - 17 Years of Experience - Near 46321

SUMMARY OF CLINICAL EXPERIENCE Eleven years' experience as a CRA which includes 2 years as a Lead CRA in clinical trial monitoring, including study start up, study initiation through closeout, as well experience in International, and Domestic studies. Provide on-site clinical trial monitoring and full site management at investigational sites in the conduct of Phase II-IV clinical trials. Recruited and trained CRA (s), inves...

Tags for this Online Resume: Data Management, Gastroenterology, Management, Patient Education, Pharmaceutical Industry, Start up, Clinical Research, Research

Management - 18 Years of Experience - Near 20814

Career Summary Management and Training Leader with extensive experience in program, product, budget and staff management, client relations and program evaluation. Demonstrated excellence in writing manuals, reports, proposals, speeches, training curricula and marketing strategies. Design effective and successful strategies and plans for implementing multi-million dollar state and federally funded programs and/or projects. *...

Tags for this Online Resume: Communications, Program Manager, Training, Services, Budgeting, Evaluate, Gateway, Home Care, Home Health

Application Support - 6 Years of Experience - Near 37076

35 years Medical Laboratory professional Areas of Expertise * Clinical Applications Technology * Regulatory Guidelines * Information Technology * System Security / Confidentiality * Product Development * Lean Process * Employee Retention * Laboratory Efficiency and Compliance * Needs Analysis & Implementation * Consensus Building & Teaming * Profitability Improvement * Performance Optimization * System Builds * Budgets * Sy...

Tags for this Online Resume: Support, Chemistry, Hematology, Management, Medical, Applications, CERNER, Compliance, Infrastructure, Microbiology

Quality Coordinator - 6 Years of Experience - Near 60504

PROFESSIONAL SUMMARY: * Total of 9.5 years of experience in Health Care industry. 6 years' experience in Clinical Data Management. * Worked as a Clinical Data Coordinator in Quintiles Technologies from Feb 2011 to Aug 2014. * Worked as a Clinical Data analyst in PAREXEL International from Aug 2008 to Feb 2011. * Also, I have 3.5 years of experiences in Medical Microbiology field in health care sector I started my career as ...

Tags for this Online Resume: Data Management, Health Care Industry, Management, Microbiology, physical therapist

Featured Profile

Director of Quality & Regulatory- 22 Years of Experience - Near 45142

Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...

Ideal Companies: A company with suability, growth and development of their employees.

Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory

R&D project Leader - Materials Engineer - 20 Years of Experience - Near 18940

ACCOMPLISHMENTS * Lead the development of numerous market-leading dental alloys, porcelains and composites, including the world's bestselling dental porcelain system with $17M annual sales * Coordinated the development and successful clearance of multiple Class II medical device 510 (k) s. * Developed multiple product validation and verification plans as per Global Innovation Process (GIP) requirements in compliance with IS...

Tags for this Online Resume: nanotechnology, composite materials, alloys, advanced materials, medical device, aerospace, automotive, metallurgy, dental, project leader, project manager, timeline, project planning, 510k, FDA, BSI, cGMP, Troubleshooting, Field Testing, metal matrix composites, ISO testing

Biologist - 1 Years of Experience - Near 28435

To whom it my Concern: My name is Loretta A. Skowronsky. The purpose of this correspondence is to express my interest in your Biology position in North Carolina. For the past several years, I have worked professionally in the medical field as a Licensed Practical Nurse. Recently, I graduated from UNCW and obtained my Bachelor’s degree in Biology. While working in the medical field I assisted physicians with many procedu...

Tags for this Online Resume: Cardiology, Behavioral Health, Nephrology, CCU, ICU, PEDS, Pharmacology, Thoracentesis, Ventilators, Phlebotomy

Administrator - 11 Years of Experience - Near 49512

Executive leader with expertise in multiple facets of fiscal management, financial analysis, and controllership within high-profile corporations. Proven experience overseeing global operations of health & human services agencies. Demonstrated success in diversifying products and services to attract private investors and extensive experience turning loss into revenue. Strong knowledge of clinical operation standards, healt...

Tags for this Online Resume: Behavioral Health, Complaints, Managed Care, Management, Therapy, Assessments, Evaluate, Integrate, Messaging, Nursing, social services

Dental Assistant - 5 Years of Experience - Near 08820

Summary Highly skilled medical doctor with more than 15 years medical knowledge in various therapeutic area. 5 years' experience as Clinical Data Manager ensuring that data for clinical trials is properly collected, validated and clean. Diligently evaluate data, verify results and present conclusions. Excellent track record when it comes to consistent quality and reliability in carrying out research duties according to regu...

Tags for this Online Resume: Coding, Data Management, Data Quality, Database, Management, Quality, Quality Assurance, Data Analysis, Data Entry, Oracle

Business Analyst - 8 Years of Experience

PROFESSIONAL SUMMARY: * Extensive Business Analyst/Project Management experience in investment banking with a strong finance background.. Heavy QA and project management experience with regulatory, credit risk, general ledger, financial reporting and treasury applications. Broad and deep experience with all aspects of the SDLC from planning through implementation and support, including business requirements gathering, docum...

Tags for this Online Resume: Applications, Management, Information Technology, Structured Query Language, Support, Business Analysis, Business Analyst, Business Requirements, Derivatives, Documentation, sql, java, linux, javascript, it jobs, c#, c++, agile, html, software

Quality Assurance Director - 20 Years of Experience - Near 60440

Summary of Experience An exceptional operations professional with more than 20 years in a healthcare setting. Established and implemented regulatory policies and procedures, quality services and revenue management metrics. Responsible for all provider claims reimbursements, satisfaction and provider contract negotiation functions and oversight. Experienced in payment software, quality audits and technical problems associate...

Tags for this Online Resume: Services, Financials, Management, Behavioral Health, Business Operations, Project Management, Project Manager, director operations, Provider Network, Claims Operation, Healthcare

Biologist - 20 Years of Experience - Near 28435

To whom it my Concern: My name is Loretta A. Skowronsky. The purpose of this correspondence is to express my interest in your Biology position in North Carolina. For the past several years, I have worked professionally in the medical field as a Licensed Practical Nurse. Recently, I graduated from UNCW and obtained my Bachelor’s degree in Biology. While working in the medical field I assisted physicians with many procedu...

Tags for this Online Resume: Cardiology, Behavioral Health, Nephrology, CCU, ICU, PEDS, Pharmacology, Thoracentesis, Ventilators, Phlebotomy