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Online Resumes with "ICH"
Chemist - 16 Years of Experience
Tags for this Online Resume: pharmaceutical, ich, cGMP
Clinical Data Management
To utilize my knowledge, skills and attitude towards growth & try my level best to reach the hallmark of the organization, which would continuously challenge my interpersonal, communication and organizational skills
Tags for this Online Resume: Management, Protocol, Data Management, Distribution, Quality, Quality Assurance, Quality Control, Query, SAS, Script, oncology, pharmaceutical, protocol, OC-RDC, InForm, ICH GCP
Clinical Research - 4 Years of Experience - Vancouver, B.C
HIGHLIGHTS OF QUALIFICATIONS * Over 4+ years of progressive work experience in clinical and academic research hospital settings, collaborating with investigators and a multidisciplinary health care team in the recruitment of study participants for various investigator-initiated and industry sponsored clinical trial studies. * Strong working knowledge of guidelines and policy governing clinical research and applicable regula...
Tags for this Online Resume: Protocol, Collection, COPD, Pulmonary, Scheduling, Specimen Collection, Amazon Elastic MapReduce, Applications, Assessments, Attention to Detail, cro, pharmaceutical, clinical trials, research, clinical, regulatory, phase i, phase ii, phase iii, phase iv
Clinical Research - 12 Years of Experience - Near 07086
EXPERIENCE Summary Write and review protocols that are in-line with the indication strategy. Conduct medical review and interpretation of efficacy and safety data from clinical trials. Responsible for the quality, coordination, medical accuracy, and timeliness of clinical study reports, review of Investigator Brochures, CTAs, Safety Data, Clinical Trial reports. Review and provide US feedback to protocols. Work with Clinica...
Tags for this Online Resume: Biopsy, Data Management, Management, Research, Chemotherapy, Clinical Research, Drafting, Process Improvement, Program Manager, Radiation
Clinical Research
PROFESSIONAL SUMMARY Registered Medical Assistant with substantial customer service experience, practical laboratory and field research background. Read books "The CRA's Guide to Monitoring Clinical Research" and Principles of Good Clinical Practice". Enthusiastic, dependable, self-disciplined, and goal-oriented team player. MEDICAL QUALIFICATIONS Certified Registered Medical Assistant (RMA) with American Medical Technologi...
Ideal Companies: Inventiv Health, Dartmouth Hitchcock
Tags for this Online Resume: Customer Service, Documentation, Health Insurance Portability And Accountability Act, ICH, Medical, Microsoft Excel, Microsoft PowerPoint, Monitoring, Occupational Safety and Health Act, OSHA
Clinical Regulatory Affairs - 1 Years of Experience - Near 02215
PROFESSIONAL SUMMARY I am seeking challenging and interesting opportunities in the areas of Regulatory Affairs, Quality Assurance, Drug Safety and Clinical Research. I possess strong written and communication skills with minute attention to detail. I am a dedicated team leader who can be relied upon to help achieve targets.
Tags for this Online Resume: Medical, Adobe, Clinical Research, Data Entry, Documentation, ICH, Integrated Development Environments, ISO, Microsoft, Microsoft Excel, clinical, protocol, pharmaceutical, trial, phase
Clinical Regulatory Affairs - 2 Years of Experience - Near 02215
PROFESSIONAL SUMMARY: A Regulatory Project Manager with 2+ years of managing IND/NDA/BLA review processes and 1+ years of cGMPs experience in pharmaceutical industry. Deadline-driven and highly reliable professional, successfully managing over 300 applicants' submissions in IND, NDA, BLA, and BSE as well as participating in 4 cGMPs sponsors' inspections (Japan and Taiwan) and 1 FDA inspection at manufacturing plants. Great ...
Tags for this Online Resume: Compliance, Pharmaceutical, Project Management, Regulatory affairs, CMC, NDA, IND, BLA, cGMP, GCP, ICH
Physician Assistant - 16 Years of Experience - Near 01760
Summary of Qualifications Proficient in GCP, ICH and federal regulations and guidances Independently managed all aspects of clinical trial coordination from pre-initiation to close-out Consistently met extremely tight timelines through strong organizational skills and ability to prioritize Identified as key thought leader by pharmaceutical companies and other healthcare professionals Creative thinker and problem solver, det...
Tags for this Online Resume: Clinical Research, physician assistant, outpatient, Patient Education, 16 years of experience, Boston Metrowest Area
Chemist - 20 Years of Experience - Near 10950
Tags for this Online Resume: chemist, High Performance Liquid Chromatography (HPLC), Assessments, Inventory, ISO, ISO 9000, Manufacturing, Chemistry, HTTPs, Documentation, pharmaceutical, ich
Clinical Research - 1 Years of Experience - Near M1W 2T1
Foreign-trained medical doctor and clinical research professional with CRA Professional Development Clinical Site Monitoring & ICH GCP Training. Experienced in clinical study files review to ensure accuracy of all the documented data including ME & AEs. Comprehensive knowledge of clinical research methodology and proficient in Phase I-IV clinical studies and ICF processing and study protocols. Excellent time management and ...
Tags for this Online Resume: Toronto, Canada, Strong Clinical Trials & Medical Management background, Detail Oriented, Data Review, Clinical Trials Supervision, Team player, Quick Learner, Certified CR Professional with Medical Background, Compliance, Documentation, clinical, research, phase i, phase ii, clinical trials, phase iv, pharmaceutical, cro
Director - 20 Years of Experience - Near 08520
ACCOMPLISHMENTS * Lead client teams and CDMOs in Product Risk Assessments, EHS Analyses, Regulatory Audits, FDA PAI readiness program, interfaced with US Environmental Protection Agencies for new and updated Air Emission and Wastes Water Effluence permits. Manage OSHA training and audit programs. Reduced product technical and compliance risks while saving safety-related operating cost by reducing planned budget by >10%. Ben...
Tags for this Online Resume: Engineering, Manufacturing, Compliance, ECMS, HVAC, Infrastructure, Material Handling, OSHA, Business Development, Management, director, consultant, regulatory compliance
Chemist
Summary * Experienced Quality Assurance scientist in the pharmaceutical and biotechnology industry working for over 17 years in a cGMP and GLP regulated environment. * Lead efforts in the business analysis for the group's business continuity program and the implementation of the Laboratory Information Management Systems (LIMS). * Knowledgeable in Project Management methodologies like 5S, LEAN and Six Sigma. * Skilled in ana...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Microsoft, Microsoft DOS, Microsoft Windows, Applications, Benefits, Business Analysis, Business Analyst, Documentation, Information Technology, pharmaceutical, sap
