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Online Resumes with "submission"
Clinical Research - 20 Years of Experience - Near 33406
• Clinical Research Consultant with over 28 years of Pharmaceutical/Biotech experience including Phase I – III clinical trial development with direct involvement in multiple FDA/ICH submissions leading to six NDA approvals. • Extensive monitoring domestically and internationally, training and mentoring innumerable CRAs/Monitors in the field which lead to further training responsibilities with Study Teams and Management Te...
Tags for this Online Resume: Florida, Pharmaceutical Research, Monitoring, Management, Team Building
General Manager, - 20+ Years of Experience - Near 234500
I am passionate about helping Organizations overcome challenges and find a way to make their lives easier. That is why in all the jobs I have had until now, I am known as someone who is creative and innovative, interested in solving problems, helping people make smarter choices, and finding better and more efficient ways to get things done. I am drawn to Project Management, because it is at the heart of all the things peop...
Ideal Companies: No preference.
Tags for this Online Resume: Project Management, Project Adviser, Fabrication, Management, Microsoft Access, Outsourcing, Procurement, Honeywell, Quality, Quality Assurance
Experienced and dedicated pharmacist looking to make a difference to others and the community
to further my career in pharmacy field,gain added experience in new frontiers
Ideal Companies: Retail environment
Tags for this Online Resume: Experienced, Retail, Pharmacist
Clinical Research - 6 Years of Experience - Near 92649
Experienced Clinical Research Professional interested in positions within the pharmaceutical or medical device industry.
Ideal Companies: inventiv, johnson & johnson, covance, covidien, peregrine
Tags for this Online Resume: Irvine, CCRP, regulatory affairs, clinical project manager, EDC, budgets , timelines, contracts and budgets
Clinical Research - 10 Years of Experience - Near 85283
PROFILE:Handled, performed, and managed the most challenging and complex Phase One Project studies in the world involving but not limited to: Leukemia, Breast, Ovarian, and Solid Tumors in both Hematology and Oncology. Managed multi-disciplined projects and tasks involving, but were not limited to all patient responsibilities, the ordering and interpretation of all clinical tests involving Laboratory, X-Ray, CAT, and Pet ...
Tags for this Online Resume: Biotechnology, managerial, MBA, Project Management, articulated, executive operations, clinical research, clinical trials
Editor - 12 Years of Experience - Near 19025
Manage multiple client projects from inception to written and electronic delivery. Responsible for development of quarterly specialty publication. Develop article ideas, assign writers, select complimentary art to enhance publication in addition to editing publication. Develop outlines for RFPs that lead to generation of publication content. Edit product feature articles for factual accuracy and grammatical correctness. Dev...
Tags for this Online Resume: Philadelphia, Editor, Microsoft, InDesign, Manage, Writing, Proofreading
General Manager - 20 Years of Experience - Near 99026
• Knowledgeable Project/Office Manager demonstrating exemplary leadership abilities, sales skills, service promotion, organizational management, quality control and budget/cost management coupled with strong business acumen. • Maintain technical knowledge of specification development, equipment functionality and production methods. • Recognized as a strong team builder/trainer, ensuring optimal performance to exceed client...
Tags for this Online Resume: Spokane, Manager, Quality control, budget, Marketing
Clinical Quality Assurance - 20 Years of Experience - Near 94403
QA/QC experience working with FDA ICH and Japanese regulations 21 CFR reviewing Writing editing submission documentation SOPs Protocols Reports. Product/Project analytical requirements evaluation budget in-house vs. out-source estimation. Upgrading of R&D laboratories to GLP/GMP level.
Ideal Companies: small start-up company
Tags for this Online Resume: methods transfer validation, phase I, II, III protocols and reports, GMP GLP, Laboratory management, hiring training budgeting, FDA ICH regulations, validation monitoring transfer, medical devices, Consulting, Document Review, Documentation, DSC, High Performance Liquid Chromatography (HPLC)
Chemist - 15 Years of Experience - Near 98122
I am interested in a job in a pharmaceutical or biotechnology laboratory. I have an extensive experience in conducting regulatory studies for EPA submissions. My work included method development, instrument maintenance and troubleshooting, data management and report writing.
Tags for this Online Resume: LC-MS/MS, HPLC, GC-MS, SPE, GLP
Project Manager
It is my goal to obtain a position as a project coordinator and or project manager in the financial industry. Since my entry into the Credit Administration and Serving area of Banking, I have proved both my extensive knowledge of Portfolio Management for Lending Products and well as branching off into Project Management at every opportunity culminating in taking on an exclusive role as a project manager in support of Regul...
Ideal Companies: Investment Banks, Financial Institutions, Regulatory Agencies, Financial Services Companies, Audit Companies
Tags for this Online Resume: Credit Administration, Data Management, Project Management, Project Coordinator, Business Analyst, Business Intelliigence, Credit Documentation Manager, Documentation Management System
SR. PHARMACEUTICAL QUALITY SYSTEMS & VALIDATION PROFESSIONAL
Seeking Pharmaceutical QA Position - - Full Time or Consulting Position SR. PHARMACEUTICAL QUALITY SYSTEMS AND VALIDATION PROFESSIONAL with a broad knowledge of regulatory compliance and quality control and assurance expertise in cGMP manufacturing, operations, regulatory, supply chain management, and validation as applied to aseptic parental pharmaceutical products, tablets, APIs, and medical devices. My experience in...
Ideal Companies: Pharmaceutical or Medical Device Companies, (Abbott; Abbvie; Hospira, Johnson & Johnson)
Tags for this Online Resume: North Carolina, South Carolina, Florida, Texas, Missouri, Chicago, Atlanta, Associate Director of Quality Assurance, Quality Assurance Manager, Sr. Compliance QA Manager, Associate Director of Validation, Validation Director, CAPA Management, Supplier QA Manager, Director of Supplier Assurance, CMO QA Manager, Pharmaceutical QA Manager, Medical Device QA Manager, Corporate QA Auditor, CAPA Manager, API Manufacturer, Sterile Fill Pharmaceutical Manufacturer, Medical Device Manufacturer, Sr. Quality Engineer, Oklahoma, Illinois, Milwaukee WI, Validation Manager, Internal QA Auditor
Physician with 17 years experience in Clinical Development, Medical Affairs, Communication collaterals, Regulatory Submissions and Stakeholder and Risk Management, Consulting to the Pharmaceutical and Medical Device Industries.
I am looking for Consulting opportunities where i can apply my logical and scientific approach to finding solutions to complex problems within the confines of regulation. I thrive when I am working with likeminded passionate team players who value my strategic planning, attention to detail and ability to identify potential problems and mitigate against them early on. I have 7 years therapy experience in Oncology where I l...
Ideal Companies: Janssen, Merck, TEVA, Smaller Pharmaceutical Companies who are in a period of growth or perilaunch where I would be able to do Medical Affairs for them, Medical Device companies
Tags for this Online Resume: Medical Affairs, Clinical Development, Phase 1-4 clinical studies, Pharmacovigilance, Due Dilligence, Launch, KOL management, Risk Evaluation Mitigation strategy
