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Online Resumes with "FDA Regulatory"
Quality Coordinator - 16 Years of Experience - Near 75211
I'm a Clinical Research Regulatory Specialist who has over 17 years experience in monitoring & assuring FDA regulatory compliance of documents for clinical research studies.
Business Analyst - 15 Years of Experience - Near 84020
Overall Leadership responsibilities - The Global Product Controllership & Engineering Analytics Manager position will coordinate a cross-functional engineering, supply chain, quality and marketing implementation teams for all activities related to Product Controllership and the creation of a global analytics program to increase product reliability and customer satisfaction
Ideal Companies: Intermountain Medical Center, Texas Memorial Hospital, UNC, St. Mary's Hospital, Scripts Hospital
Tags for this Online Resume: Manager, Technology, Operational, Leadership, Healthcare, Siebel
Clinical Quality Assurance - 3 Years of Experience
● Over ten years of progressive Critical Care experience ● Strong computer skills and typing speed ● Pharmaceutical Research/Medical Devices-disposables, FDA regulatory reporting ● Ability to multitask and troubleshoot problems ● Ability to prioritize tasks and meet deadlines ● Knowledge of hospital setting procedures and policies ● Good communication and interpersonal skills
Tags for this Online Resume: case review, regulatory reporting, microsoft, Chicagoland, disability, workman's comp, registered nurse
General Counsel / Nurse Attorney - 20 Years of Experience - Near 67039
Use my experience as a nurse attorney [who used to litigate defective pharmaceutical and medical device cases & doing risk management & FDA regulatory reviews] to consult with various companies, healthcare providers to educate them about problem products and reduce their risks.
Tags for this Online Resume: telecommuter, nurse/attorney, auditor/risk manager, human resources, lawyer/attorney, Registered Nurse, board member, executive
PhD with Clinical Research Training and 5 years research experience - seeking Clinical Research and MSL related positions
Highly driven and dynamic scientific professional, strategic and analytical in processing and integrating scientific and clinical information. Fast learner who thrives under challenging and demanding situations with steep learning curves. Excellent written and oral communicator with an established record of effective and influential presentations at key international conferences and won best oral presenter/presentation awar...
Ideal Companies: Roche, Johnson & Johnson, Pfizer, Genentech, GlaxoSmithKline (GSK), Sanofi, Novartis, Bristol-Myers Squibb, Abbott, Bayer, Merck & Co., AstraZeneca, Amgen, Lilly
Tags for this Online Resume: Scientific Expertise, Written and Oral Communication, Leadership qualities, Time Management, Clinical Research, Scientific Liaison, PhD, Relocatable
FDA Regulatory Inspector
Study Coordinator
Summary Study Coordinator with 6 years' experience specializing in technical support of animal studies requiring GLP compliant interpretations, analysis, documentation, and reporting of results per FDA regulations beginning with protocol development support and creation of shell reports resulting in a Final product ready for FDA Regulatory Filings. Areas of Expertise / Core Competencies * Highly dependable, focused and dete...
Tags for this Online Resume: Documentation, Good Laboratory Practices, Protocol, Analytical Skills, Biomedical Industry, Quality, Quality Assurance, Coordinator, Medical Devices, Regulatory
Clinical Research - 1 Years of Experience - Near 27704
A goal-driven dependable and dedicated management professional with over 12 years' solid experience in Clinical Data Management operations at a non-profit organization. Has extensive knowledge of GCP ICH and FDA regulatory requirements regarding management of clinical trials data. Expertise in data management practices for paper studies as well as electronic data capture systems. Has a proven ability to effectively communic...
Tags for this Online Resume: Data Management, Email, Management, Query, Training, Documentation, Clinical Research, Compliance, Data Entry, Project Management
Director
SUMMARY OF QUALIFICATION * Extensive experience in FDA regulatory requirements (GMP, CFR) and ISO standard regarding Medical Device, Pharmaceutical, Skin Care, and Food Industry * Extensive experience Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma 5S, and SPC to assure efficient process and high product quality product * Extensive experience in managing the Supplier/ Vendor qualification program, Supp...
Tags for this Online Resume: Extensive experience in CAPA, Extensive experience in IQ/OQ/PQ VAlidation, Extensive experience Quality audit, Extensive experience Supplier Qualification, Extensive experience FDA and ISO Regulatory, Extensive experience Process and Quality improvement, Extensive experience Reducing customer complaint, Scheduling, Chemistry, Good Manufacturing Practices
Executive Assistant - 15 Years of Experience - Near 95132
Skills Summary Soft Skills *Marketing Sales * Front Office Operations * Culturally Diverse *Report Generation * Scheduling/Calendaring * Work Independently *General Office Skills * Administrative Training * Professional Demeanor *Accounting/Bookkeeping * FDA/Regulatory Submissions * Innovative/Creative techniques * Customer Service * Purchase Requisitions (SAP) * micro-mange calendars Word Processing Skills * MS Word *SAP *...
Tags for this Online Resume: Accounting, Certificate Authority, Customer Service, Front Office, Generate Reports, Lotus, Lotus Notes, Marketing Management, Microsoft, Microsoft Access
Vice President - 20 Years of Experience - Near 89134
An executive level position leading a Program Management Office, Business Process Optimization, Information Technology, Process Change and/or Manufacturing Ops that will integrate 25+ years of experience including strong Program & Project Management, Mergers & Acquisitions, Six Sigma, Supply Chain Integration and leadership skills with the analysis and usage of IT/IM solutions to enhance and improve new or existing processe...
Tags for this Online Resume: Management, Product Development, Program Management, Project Management, Reporting Tools, Budget Control, Budgeting, Integrate, AT&T, Data Management, Vice President, Senior Director, Portfolio Strategy Program
Pharmaceutical Quality Assurance - 8 Years of Experience - Near 43016
Tags for this Online Resume: Test, Documentation, Manufacturing, Pharmaceutical, Risk Assessment, Distribution, Scheduling, Clinical Research, High Performance Liquid Chromatography (HPLC), Microsoft Access, GMP, FDA Regulatory
