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Online Resumes with "ICH "
Clinical Research - 2 Years of Experience - Near 77449
HIGHLIGHTS OF QUALIFICATIONS: * RN with close to 2-years experience in clinical trials monitoring * Knowledgeable of clinical trial procedures and approval processes. * In-depth knowledge of ICH GCP guidelines and FDA regulations * Conversant with Design and Review of case report forms (CRF) * Conversant with Site Monitoring visits (PSVs, SIVs, IMVs and COVs) to meet study expectations. * Clinical and post-marketing safety ...
Tags for this Online Resume: Direct Patient Care, DRESSING CHANGES, Medical, Patient Care, Suctioning, Surgical, Wound Care, Acquired Immune Deficiency Syndrome (AIDS), HIV, Monitoring
Scientist - 15 Years of Experience - Near 10583
Summary: Molecular Biologist with expertise in highly driven research environment experience ranging from writing grant proposal, MTAs with pharmaceutical companies, planning experiments, wet bench laboratory techniques, data collection, analysis, writing articles for publication in journals, preparation and presentation at National and International meetings to teaching and training students and fellows and supervising tec...
Tags for this Online Resume: Oncology, Research, Cancer, Pharmaceutical, Translation research, Medical writing, liaison, Management, Senior scientist, Clinical scientist, CRA, scientist, oncology, cancer research, medical liaison
Clinical Research
Summary of Qualifications Clinical Research Manager, Associate, Monitor, Coordinator, with over 25 years experience in the medical field and 21 years experience in clinical trials with extensive experience in the fields of Cardiology, Electrophysiology, Neurology, Urology, Autoimmune, Respiratory, Gastroenterology, Weight Loss, Diabetes, Women's Studies, Arthritis, COPD, Gynecology, Endocrinology, Rheumatology and Stem Cell...
Tags for this Online Resume: Monitoring, Protocol, Cardiovascular, Clinical Research, Management, Pharmaceutical, Research, Therapy, Audit, Data Management, Medical Device, CRA, CTM, Clinical Trials
Developer - 7 Years of Experience
PROFESSIONAL SUMMARY * Over 9 years of Clinical SAS programming experience in a Pharmaceutical industry involving different Phases (I, II & III) of clinical trials. * Experienced in working closely with statisticians to provide SAS programming in analyzing clinical trials data and generating Statistical Analysis Files, Tables, Listings, Summaries and Graphs/Figures (TLFs) for the Integrated Summary of Safety (ISS) and Integ...
Tags for this Online Resume: Microsoft Windows, SAS, Structured Query Language, Unix, Microsoft Windows 7, Windows 7, PDF, Proc, Extensible Markup Language (XML), Microsoft Excel
Clinical Research - 5 Years of Experience
Tags for this Online Resume: Analytical Skills, Applications, Clinical Research, Coding, Communication Skills, Data Management, Excellent Communication Skills, ICH, Management, Metrics
Chemist - 15 Years of Experience - Near 07059
PROFILE Analytical Chemist with over 15 years of experience in the Pharmaceutical industry. Experience in developing and validating analytical methods to satisfy regulatory requirements. Broad range of knowledge and experience working with new chemical entities (NCE), raw materials and finished products including structure elucidation, testing, quality assurance, regulatory compliance and submission. Known for ability to tr...
Tags for this Online Resume: ICH, Chemistry, method validation, Test, Pharmaceutical, Quality, GMP, Analytical method development, UPLC, HPLC, GC, LC-MS, LC-MS, GC,HS-GC
Microbiologist - 20 Years of Experience - Near 45066
Summary of Experience William H, Fleming, III, PhD has thirty five plus years in the plasma, biopharmaceutical, medical device, contract manufacturing and hospital based clinical industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished plasma derived drug products, medical devices, small molecule sustained release microsphere based drug products, biological prod...
Tags for this Online Resume: Regulatory Compliance, Regulatory Affairs, Regulatory Compliance Auditing, Analytical Chemistry, Method Validation, Process Validation, Microbiology, Standard Operating Procedures, CMC BLA 510K, Policies and Procedures
Clinical Pharmacovigilance/Drug Safety - 15 Years of Experience - Near 10016
Areas of Expertise * Drug Safety Pharmacovigilance * Clinical Research * Medical Review/ EMR * ICH Guidelines * Real World Evidence Medicine * Medical Coding
Tags for this Online Resume: Drug Safety, Clinical Research, Data Management, Documentation, ICD-9, Management, Medical, Pharmaceutical, Research, Therapy, Real Word Evidence Medicine, Medical Case Reviewer, ICD-10, ICPC, CPT, Bilingual, Pharmacovigilance
Quality Systems Specialist - 20 Years of Experience - Near 94545
Summary * Multiple years' experience and thorough understanding of technical and business requirements for Biotech in clinical and commercial multi-product manufacturing facility. * Knowledge of regulatory expectations and requirements for protein purification facilities and industry standards and practices, manufacturing processes, cleaning validation, safety principles, quality systems, cGMPs, engineering design fundament...
Tags for this Online Resume: GMP, Troubleshooting, NPI, Change Control, Data Analysis, Management, Manufacturing, Product Development, Quality, Quality Assurance
Environmental Scientist - 16 Years of Experience - Near 45267
Tags for this Online Resume: Support, Technical Support, Consumer Products, Database, Management, Database Maintenance, ICH, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, chemical risk assessment
Clinical Research - 20 Years of Experience - Near 60202
QUALIFICATIONS * Internist with 20+ years experience working in the the pharmaceutical industry including small, medium and large pharma, CRO and biotech in the USA, Canada, LatinAmerica, and Europe (including Eastern Europe), and Russia. * Board Certificatioon in Internal Medicine and training in Critical Care Medicine. Clinical practice experience in Hospitals, Emergency and Critical Care settings. * Extensive experience ...
Tags for this Online Resume: Project Leader, Executive Medical Director/VP, Protocol, Cancer, COPD, Critical Care - Respiratory, OTC, Clinical Programs, Research and Development, CardioVascular, Pain & Inflammation
Business Analyst - 17 Years of Experience - Near 11725
SUMMARY Business Analyst / Validation Lead / Specialist / IT/QA Compliance Specialist with Pharmaceutical, IT, Manufacturing and Software QA experience: An IT professional with extensive experience in QA/Compliance, Testing, SQA, PM, Validation and Documentation specialties include: * Business Analyst experience consists of specializing in writing business workflow processes and translating them into Business, Functional an...
Tags for this Online Resume: Compliance, Information Technology, Test, Quality, Training, Good Clinical Practices, HP, ISO, Good Laboratory Practices, Manufacturing
