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Were you looking for FDA-ICH-guidelines job results?
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Online Resumes with "FDA ICH guidelines"
Senior/Lead Clinical Research Associate
Seasoned Clinical Research Professional with 10+ years experience in Clinical Research, including, CRA, Lead CRA, and Project Management duties. THerapeutic areas include oncology, endocrine/metabolism, and CNS.
Ideal Companies: biotech, pharma
Tags for this Online Resume: clinical trials manager, oncology, clinical research
Senior-level Scientist/ Technical Leader
A visionary, dynamic and effective technical leader with a proven track record of scientific vision, innovation and accomplishment to lead and manage R&D and Engineering teams. Excellent problem-solving skills combined with strong organizational, communication and interpersonal qualities to effectively function across multidisciplinary teams. Highly proactive, results and performance driven to meet and exceed business goals...
Ideal Companies: J&J, Abott, Pfizer, Bausch & Lomb, Ciba Vision, Boston Scientific, Coca Cola, Georgia Pacific, Wyeth, Novartis
Tags for this Online Resume: chemist, polymers, Materials
Sr. Clinical research Associate/ Director of clinical research
Can undertake most of the tasks and works independently. Very much focussed on the timelines and quite goal tending. Willing to help others in their prioritized tasks. Excellent planning, design and implementation. Highly experienced in writing reports and data analyses.
Ideal Companies: Pharmaceutical industries, Biotech companies, Research institutes, hospitals and for profit mid to large companies.
Tags for this Online Resume: Director of clinical research, Manager of drug safety, Senior clinical research associate, Regional clinical research associate
Clinical Supply Operation, Edison, NJ - 8+ Years of experience in pharmaceutical R&D, Clinical supply operations. Knowledge and experience in GMP, GCP and FDA/ICH guidelines. Good experience of computer programming and use of MS Suite of Applications, Dat
Lead Project Manager- Clinical Trials
Proven expertise in managing teams, streamline project paths encompassing an understanding of scientific data, analysis and interpretation of results, clinical developability and commercial viability of projects.
Ideal Companies: Vertex Pharmaceuticals, Amgen Inc., Takeda Pharmaceuticals
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)
Life Scientist - 8 Years of Experience - Near 27617
Summary Ph.D in Pharmaceutics with extensive experience in analytical method development, method transfer and validation for Small and Large molecular API, in a GMP environment. Specialized in mass spectrometry/LC-MS method development and troubleshooting. Good knowledge of the GMP, GLP, SOP practices, the USP, EP, NF, FDA and ICH guidelines. Proven problem solver, motivated team leader and excellent communicator Qualificat...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), ELISA, protein, Protocol, LC-MS, MASS, API, Process Improvement, Application Program Interface, FORMULATION, QC, ANALYTICAL, pharmaceutics
Clinical Quality Assurance - 20 Years of Experience - Near 19713
AREAS OF EXPERTISE * Quality Assurance, CAPA * Regulatory Stability Documentation * Quality Systems * Strategic Project & Team Management * Troubleshooting / Problem Solving * Stability protocols, SOP's * USP, BP EUP, JP * FDA and ICH guidelines * Chromatographic Data Systems * Method validation and metrics * Lab Inspections & Evaluations * Product Support / Quality Control * Standard Operating Procedures
Tags for this Online Resume: Stability, Quality Assurance, Data Management, Quality Control, Data Analysis, LIMS, Reference Standard, COA Management, FDA and ICH Guidelines, USP,EUP,BP,JP, HPLC, GC etc., pharmaceutical, protocol, ich
Pharmaceutical Scientist
ver fifteen years of solid experience in pharmaceutical Quality Assurance, Quality Control, Stability, Analytical methods development, Validation, Instrumentation, Lab supervisor and Academic. Accomplished, results-oriented individual with expertise in pharmaceutical area. Extensive hands on experience with HPLC, TLC, GC, TGA, UV/VIS, FTIR, IR, AA, Fluorescence Spectrophotometer and Dissolution. Up-to-date knowledge of cGM...
Ideal Companies: J&J, Celgene, Merck
Tags for this Online Resume: Scientist
