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Online Resumes with "fda "



Regulatory and clinical affairs -- 20 years experience

A position in regulatory affais/medical writing for human clinical trials

Tags for this Online Resume: medical writing, regulatory affairs, FDA regulations, clinical. research, clinical trials, medical research

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Director of Life Sciences Consulting

Lead a Life Sciences Practice and ultimately progress to the VP level.

Ideal Companies: Business and IT consulting firms in life sciences;professional services firms in life sciences.

Tags for this Online Resume: Program Director, Process Optimization, Systems Integration, Human Performance Optimization, Application Design & Development, Leadership, Research and Development, Clinical Research, Clinical Research and Development, Regulatory Affairs, Safety Surveillance, Marketing and Advertising, R and D

Project Manager

Edward Koza, Jr. 10 Whittier Road Clark, NJ, 07066 Home - (732) 381-4389 Cell – 732-694-9073 E-mail – edjet21jr@hotmail.com Re: Sr. Manager/Asst. Director Prior to the sale of the Pharmaceutical Technologies & Services, a division of Cardinal Health I was Director of the Global Application Support Team. Together we were responsible for 528 applications that made up of the main ERP applications, SAP (for Distr...

Tags for this Online Resume: 21CFR Part 11, GXP GMP, Sox FDA, SiX Sigma Green Belt, PMBOK, Oracle/ SAP

Quality Assurace Masnager

Director of Quality Verstal in ISO and FDA Quality Systems.

Ideal Companies: aerospace, Medical

Tags for this Online Resume: NDT, Inspection, R&D, Welding

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Regulatory Affairs Associate, New Jersey

Regulatory Affairs professional with a strong regulatory and compliance foundation, well-versed in the laws, regulations and requirements of the FDA; over six years of experience as an International Coordinator for a pharmaceutical organization, currently completing a graduate degree in Regulatory Affairs in Drug Development, Biologics and Medical Devices, studying all facets of regulatory requirements including processes a...

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Quality Assurance Specialist, San Jose

To obtain a Quality Assurance position that ensures company conformance with FDA and ISO standards, manage a department by achieving quality performance metrics and support Service Center operations in maintaining the quality of repair operations throughout the organization.

Director of Program and Portfolio Management - Medical Device

To utilize my 30+ years experience to help an organization be successful in product development. Specifically I would like to apply my experience of running a PMO and being responsible for portfolio management to drive a company to a higher level of success.

Tags for this Online Resume: Program Management, Product Development, FDA Design Controls, Lean Six Sigma, Change Management, Portfolio Management

Corporate Compliance Administrator

My range of experience began with hands-on work testing and measuring products, and I then went on to supervision and documentation. When I moved into a corporate role I became an expert on administration of Quality Systems and Documentation Systems, adapting this infrastructure to address new product classifications, new manufacturing sites, and new regulatory requirements. I was responsible for monitoring regulatory chan...

Tags for this Online Resume: Quality Assurance, Regulatory Affiars

Clinical Research Coordinator & Data Manager

To efficiently conduct all aspects of clinical trials and ensure the protocol requirements are met in accordance with FDA guidelines, Good Clinical Practices, sponsor specifications, and internal policies and procedures.