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Online Resumes with "Regulatory approval"
Medical Office Manager - 1 Years of Experience - Near 02120
Seeking a position to utilize my skills and abilities in the corporate sector that offers professional growth which is being resourceful, innovative and flexible. Knowledge of ICH guidelines and safety reporting requirements, good manufacturing practices (GMP), good laboratory practice (GLP) and good clinical practices (GCP). Understanding of FDA regulations and knowledge of IND, NDA, BLA, Drug Master File (DMF), 510(k) and...
Tags for this Online Resume: Boston, GLP, GCP, FDA Regulations, Medical Device
Architect - 20 Years of Experience - Near 53219
SUMMARY Senior Architect / Project Manager/ Owner's Representative with extensive experience managing the design, construction, and occupancy transition for complex building projects. Detail and process-oriented professional with a reputation for applying tenacious, inquisitive, rational and analytical approach to optimize project success. * History of Managing: budget, schedule, scope, quality, risk, and regulatory approva...
Tags for this Online Resume: Architect, Owner's Representative, Project Manager, Construction, Health Care Industry, Project Architect, Budget Management, Schedule Management, Regulatory Approvals, Risk Management, Quality Assurance, Sustainable Design/LEED
Engineer Manager - 15 Years of Experience - Near 08536
PROFILE Experienced project management professional and Professional Engineer that is a well-rounded technically and has demonstrated the capacity to contribute to the strategic planning of mega and major projects. Able to integrate corporate goals within the execution of capital programs and has the insight to achieve development results while building consensus among key stakeholders. Proven track record of leadership and...
Tags for this Online Resume: Management, Project Management, EPC, Leadership, Engineering, Planning, Assessments, COGEN, Cogeneration, Compensation
Clinical Regulatory Affairs - 20 Years of Experience - Near 55311
Summary of Specialized Skills * Design, development and conduct of device based Clinical and Pre-Clinical Research projects. * Experience in writing various clinical documents, including protocols, CERs, reports, research findings. * Design and Implementation of various Pre-clinical trials for pilot studies of various implantable technologies. * Management of scientific/animal studies and clinical projects. * Hands-on exper...
Tags for this Online Resume: Imaging, Cardiology, Integrated Development Environments, Management, Data Management, PACEMAKER, Pacemakers, Research, Clinical Research, Publications
Senior management in Life Sciences - 20 Years of Experience - Near 27516
ACCOMPLISHMENTS * CEO of six early stage life science companies multiple Board directorships * Teams brought six biomedical products into FDA process * Led raising of $150 million in venture capital, debt, and grants * Negotiated multiple licensing deals totaling >$400 million in milestones * Created/grew NovaScreen, an R&D services business (acquired by Caliper) * Created/grew Larex, a specialty chemicals company (acquired...
Tags for this Online Resume: Pharmaceutical, Biomedical Industry, Biotechnology, Business Development, Business Management, Licensing, Management, Research Triangle NC area
Visionary Leader who Energizes the Enterprise's Performance through an entrepreneurial approach to all tasks.
Dynamic CFO and leader with more than 20 years of management experience in financially oriented roles. Demonstrated expertise in financial reporting, operations, risk management and compliance. In addition to CFO roles has held COO positions as well as Chief Compliance Officer. Known for hiring, training and developing efficient staff and strong management teams.
Ideal Companies: CME Group, Exelon, Federal Reserve Bank, MacArthur Foundation, Intercontinental Exchange, E*TRADE, Microsoft, MacArthur Foundation
Tags for this Online Resume: Finance, Risk, Compliance, GAAP, Strategy, Certified Public Accountant, Leadership, Management, Financial, Financial Management, Project Management, Policies and Procedures, Risk Management, Infrastructure
Quality Manager - 20 Years of Experience - Near 37129
SUMMARY * Conduct medical device, cosmetic and pharmaceutical excipient and APIs, and supplier certification, evaluation and qualification activities, including on-site and desktop assessments of quality systems, product and process controls develop control plans for monitoring supplier corrective actions for quality, performance and delivery, employing standard industry tools (pFMEA, root cause investigation, lifecycle man...
Tags for this Online Resume: Instrumentation, Diagnostics, ISO, ISO 9001, Management, Document Management, Software, Assessments, Engineering
Clinical Research - 5 Years of Experience
Medical Doctor with Post Graduate training and Diploma in Clinical Research from AAPS Toronto * Over 14 years experience working in clinical environment. * Strong understanding of Clinical Research processes according to Study Protocols ICH/GCP
Tags for this Online Resume: Clinical Research, Management, Protocol, Research, Data Management, Good Clinical Practices, Medical, Clinical Trials, Informed Consent Forms, Study Reports, SOP, Regulatory approval
Health Technologist - 14 Years of Experience - Near 95010
SUMMARY Medical device industry veteran with experience with product development, clinical strategies implementations, regulatory approvals, clinical marketing and market development. Recognized professional who is persistent and thrives in a multi-level, fast-paced environment. Keen, innovative and dedicated individual with strong ethical and moral values. Creative thinker with the ability to challenge norm and tackle unre...
Tags for this Online Resume: Clinical Research, Research, Internet, Management, Project Management, Vendor Management, Clinical Affairs, Data Analysis, Team Management
Operational Risk Leader
AREAS OF EXPERTISE Advisor/Consultant Change Agent Execution Project direction Communications/stakeholder buy-in Solution delivery Strategic consulting Organizational change Regulatory approval Advisory (Reg/Risk) Functional integration Program development
Tags for this Online Resume: Management, Project Management, Quality Assurance, Test, Audit, Financial, Financial Services, Policies and Procedures, Regulatory Reporting, Services, Operational Risk
General - 20 Years of Experience - Near 77077
Dynamic experience of over 20 years with expertise in commercial contracts performance/reporting management and engineering in the offshore / oil and gas industry with leading companies such as ConocoPhillips and ABB. Innovative and result/goal oriented individual combining creativity resourcefulness and initiative to build a solid record of professional achievements. Recognized by clients peers and colleagues as a consumma...
Tags for this Online Resume: Architect, Engineering, Research, ABS, Budgeting, Business Management, Dos, EPC, Evaluate, Financial
Industrial Engineer - 20 Years of Experience - Near 92801
A dynamic analytical results-oriented facilities engineering professional with project management background and experience in all areas of corporate infrastructure including innovative space planning for business expansion or relocation development of budgets for capital projects and operations that emphasize company profitability and oversight of maintenance health and safety and security functions. AREAS OF EXPERTISE * P...
Tags for this Online Resume: Financial Statements, Layout, Project Management, Corrective Actions, Management, project engineer, Facilities Engineering, Capital Asset Budgeting, Project Scope Development, project manager, Supervision of Staff, Mgmt of Tenant Improvements
