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Online Resumes with "ICH"
Quality Assurance Manager / Vendor Manager - 20 Years of Experience - Near 60060
SUMMARY: Experienced, dedicated, Quality Assurance professional and trainer who provides the knowledge and skills to assist with and drive projects as part of a team or as an individual contributor. * 20+ years of experience in pharmaceutical research, 15+ in Quality Assurance * Experience with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH), Good Laboratory Practice (GLP), Vend...
Tags for this Online Resume: Quality Assurance, Test, Clinical Research, Research, Audit, Management, Pharmaceutical Industry, Development Activities, Policies and Procedures, Vendor Management, Clinical, GCP, GLP, Training, Nonclinical research, Preclinical, Early phase clinical research
Medical & Clinical Laboratory Technician
Summary of Qualifications: Growth-minded operational professional with a collaborative and innovative approach to problem solving. A proven ability to implement and execute project timelines, objectives, management and oversight of early phase global studies. Exceptional communication and relationship building skills allow continuous success with cross-functional, internal and external partnerships and stakeholders. * Diver...
Tags for this Online Resume: Management, Monitoring, Oncology, Protocol, Quality, Quality Assurance, Assessments, Filing, Financial, Planning
Clinical Pharmacovigilance/Drug Safety
Tags for this Online Resume: Good Clinical Practices, ich, PBRER, pharmacovigilance, signal detection, risk management plan, risk management measures
Quality Manager - 20 Years of Experience - Near 28457
Areas of Expertise * Project Management * Employee Training, Supervision * Quality Documentation * Analytical Problem Solving * Quality Assurance * Testing Protocols * Analysis and Evaluation * Compliance Standards * Strategic Planning * ICH Guidances * Performance Management * Team Leadership
Tags for this Online Resume: Chemistry, High Performance Liquid Chromatography (HPLC), Project Management, Project Manager, Pharmaceutical, Documentation, Management, GMP, Training, Packaging
Clinical Research - 20 Years of Experience - Near 32828
My career objective is to become a part of your Organization and to apply my experience and knowledge during the conduct of clinical trials, with emphasis on safety, efficacy in accordance to ICH-GCP, FDA and study protocol guidelines. Further, I will always strive to accomplish efficiency and savings for clients, by developing effective monitoring tools
Tags for this Online Resume: Microsoft-Office, ICH-GCP, FDA-guidelines, CTMS, EDC, RAVE, Monitoring, Clinical trials, Cardiovascular, Management, Auditing
RESEARCH ADMINISTRATION PROFESSIONAL
Dedicated Clinical Research Professional with over 10 years' progressive experience managing multiple phases of clinical research projects. Possessing advanced education, leadership, management, diplomacy and organizational leadership skills and consistently demonstrating the highest level of personal and professional standards. Seeks a varied and challenging position that will enable me to consolidate my professional exper...
Tags for this Online Resume: Oncology, Clinical Research, Diversity, Research, Consulting, Immunology, Medication Adherence, Planning, Policy Development, Strategic Planning, clinical, research, clinical trials, cro, regulatory
Clinical Project Manager
Qualifications for Clinical Trial Management Offers extensive experience managing clinical studies and developing clinically relevant products. Adapts quickly to changing priorities in fast-paced research environments. Works well independently and as a team player/leader to solve problems and ensure excellent customer service. Detail-oriented, adaptable, and organized capable of providing home - based clinical research moni...
Tags for this Online Resume: Project Management, Project Manager, Compliance, Management, Monitoring, Audit, Clinical Research, Data Management, Protocol, Research
Biochemist - 19 Years of Experience - Near 53719
SUMMARY Over 35 years of cumulative global molecular research experience with an in-depth knowledge of genetic engineering, transformation, cell-culture and aseptic techniques. Well recognized in the areas of research and product development, project management and technical support in pharmaceutical and biotech industries. Ten years of experience working with United States Pharmacopeia (USP) as Expert Committee Ad Hoc Advi...
Tags for this Online Resume: Propagation, Protocol, API, Laboratory Work, Publishing, Data Management, Management, Procurement, Research, Training
Quality Coordinator - 5 Years of Experience - Near 08817
PROFESSIONAL PROFILE SUMMARY * A Quality professional with over twenty years' experience in Pharmaceutical and Biotechnology industries. Expertise in pharmaceutical, biological and aseptic manufacturing of sterile injectable and non sterile drug products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance. Implemented...
Tags for this Online Resume: Management, Compliance, Reviews, Pharmaceutical, Audit, Documentation, Quality Assurance, Test, Manufacturing, manufacturing, production, reliability, mechanical engineer, electrical engineer, machine operator, maintenance, die cutting
Biochemist - 20 Years of Experience - Near 53719
SUMMARY Over 35 years of cumulative global molecular research experience with an in-depth knowledge of genetic engineering, transformation, cell-culture and aseptic techniques. Well recognized in the areas of research and product development, project management and technical support in pharmaceutical and biotech industries. Ten years of experience working with United States Pharmacopeia (USP) as Expert Committee Ad Hoc Advi...
Tags for this Online Resume: Propagation, Protocol, Publishing, API, Laboratory Work, Data Management, Management, Procurement, Research, Training
Clinical Research
PROFESSIONAL SUMMARY: Experienced Clinical Research Professional seeking career advancement with a CRO where I can make a positive contribution by utilizing my clinical research expertise. In-depth knowledge of clinical trial policies and procedures, study protocols, GCP guidelines, ICH guidelines, regulatory clinical trial documentation requirements, IRB documents submittal, sponsor electronic data capture systems for data...
Tags for this Online Resume: Chemotherapy, Clinical Research, Collection, Gastrointestinal, Oncology, PEDIATRIC, Protocol, Support
Admissions Director - 0 Years of Experience
SUMMARY * Pharmacovigilance Associate with over 2+ years of experience in Drug Safety and Clinical practice fields with clear understanding of EDC (Electronic Data Capture) * Experience in performing successful data management, triage, case entry, MedDRA, WHOdrug dictionaries, narrative writing, peer review, case follow-up, case review and report preparation * Performing Data entry and Quality check adverse event reports fr...
Tags for this Online Resume: Quality, General Practice, HYGIENE, Medical, Surgical, Acceptance Testing, Assessments, Business Intelligence, Coding, Database, healthcare
