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Online Resumes with "ICH Guidelines"
SUMMARY: To apply my knowledge of FDA Good Clinical Practice guidelines/ICH guidelines, extensive site/field Clinical Director, Site Lead Study Management, in addition to my experience with various therapeutic areas of medicine, to a position as a Clinical Research Associate. Achievement: Co-Author on a Publication
Therapeutic experience in IVD Oncology Hematology Orthopedics GI Cardiology Melanoma ENT Multiple Sclerosis and ADHD Extensive knowledge of FDA regulations ICH guidelines GLPs GCPs and SOPs * Monitoring experience of national and international sites for PSSVs SIVs IMVs and COVs * Ability to identify issues and resolve appropriately * Experience multiple EDC systems and platforms
PROFESSIONAL SUMMARY * Experience in design and development of variety of dosage form semi-solid (cream, lotion, gel, ointment), liquid (solution, suspension) and nasal spray. * Experienced in preformulation, characterization and formulation optimization using solubility, skin diffusion, in-vitro diffusion, viscosity, yield stress, pH etc. * Designed Quality Target Product Profile (QTPP) and identified Quality Attributes (Q...
Tags for this Online Resume: Manufacturing, Quality of Service, Distribution, SEMI, Assessments, Centrifuge, Development Activities, DSC, Good Laboratory Practices, High Performance Liquid Chromatography (HPLC), pharmaceutical, research
CURRICULUM VITAE: Sharon Woodruff Team excellence instructor, facilitator, and trainer. Proven managerial, interpersonal, and training skills. Work History Title: Senior Clinical Research Associate Company/Location United BioSource Corporation Kansas City, MO/Regional United States Dates July 2014 - January 2015 Accountabilities Implement and monitor clinical trials for medications and devices to ensure sponsor and invest...
Summary of qualifications: * Experience with Evaluating Reports and Creating Statistical sharing Platforms for Pharmaceutical Industry, Hematologic Oncology, Aphaeresis, Bone Marrow Transplantation and Cellular Treatment fields, Orthopedic Surgery, * Pharmaceutical, Furniture and Medical supply industries management and director experiences. * Representation and Building good relationship between industries and Associations...
SUMMARY OF QUALIFICATIONS Quality Systems - Quality Control /Quality Assurance Management of Analytical Laboratories/Quality Audits/Scientific Technical Services Liaison Highly motivated, key contributor in Quality Management and cGMP compliance with more than twenty five years of demonstrated growth and success in scientific applications with Contract Manufacturing Organizations in Quality, R&D and manufacturing. Recognize...
Tags for this Online Resume: Analytical Chemistry, Chemistry, Manufacturing, Research and Development, Commercial Production, Compliance, Packaging, Pharmaceutical, Documentation, Quality, validation, Audits
PROFESSIONAL SUMMARY * A proven leader with a track record of accomplishments with more than fifteen years pharmaceutical industry experience in leading analytical development activities for small molecule drug development * Hands-on experience in analytical project management in drug development and regulatory submissions hands- on experience in analytical method development/validation/transfer in GMP environments expertis...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Quantify, Analytical Chemistry, Chemistry, Research, Research and Development, Regulatory Affairs, Applications, CMOS, Development Activities
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
PROFESSIONAL SUMMARY Clinical Research Professional with various project experience from concept to development. Talents include in-depth knowledge of ICH guidelines SAE reporting and GCP auditing. Integral team-player with excellent communication skills CORE QUALIFICATIONS * Patient Recruitment & Screening * Detailed Documentation * Serious Adverse Event Reporting * Communicating with IRB for study proposal, approval and u...
To apply my knowledge of FDA Good Clinical Practice guidelines/ICH guidelines, extensive site/field Clinical Director, Site Lead Study Management, in addition to my experience with various therapeutic areas of medicine, to a position as a Clinical Research Associate. Achievement: Co-Author on Two Research Article Publications
I absolutely enjoy what I do and look forward to work every week. I know there will be challenges and problems that my team and I will have to solve. I enjoy this career because every day is different. Every study requires a different amount of care and expertise/experience. I love the organization that comes with this career. I love having my own studies and organize documents according to company SOP as well as my own way...
Tags for this Online Resume: Instant Messaging, Data Analysis, Document Management, Good Clinical Practices, Good Laboratory Practices, Management, Medical, Medical Terminology, Microsoft, Microsoft Excel, Data Entry, Site Feasibility, Trial Master File Audit, Trial Master File, Routine Monitoring Visits, Bilingual, IWRS Systems, DSMB, analysis of PK data from different generations of Japanese subjects, Receiving Plasma samples and storing them in freezers, Urine collection and UA testing, Phlobotemy, ECGs, Dosing, Writing Visit Reports, Query data sheets, Resolving Queries within the SOP allotted time frame, Pippetting Fluids and shipping off with appropriate courier., CRA visit matrixes, Reporting numbers and statistics to Project Manager and Operations Manager, Reviewing Source Documents and making original source documents according to procedures in the protocol, Protocol review sessions, QA sessions daily with a volunteer from each department to go over daily data and tasks to make sure none were missed, Call subjects and perform AE checks according to timelines on protocol, Send critical documents to sites directly or through CRAs as demanded., Make progress matrices of site visits and site reports, Send reminder emails for upcoming visits for CRAs and internal deliverables, Coder
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