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Online Resumes with "ICH "
Clinical Research - 12 Years of Experience - Near 78254
SUMMARY OF QUALIFICATIONS * Managed Phase I -IV and observational Clinical Research Trials for HIV/AIDS, HIV Vaccine trials, HIV and Hepatitis, Infectious Diseases, Hyperlipidemia, Diabetes, Renal CKD, Secondary Hyperparathyroidism, Vitamin D Deficiency, Diabetic Nephropathy, Allergies, Asthma, and Immunology, Hepatic therapeutical area, from HBV, HCV, Fatty Liver, Cirrhosis in the Liver, medical devices. * As an inhouse mo...
Tags for this Online Resume: PEDIATRIC, Pharmaceutical, Surgical, C Programming Language, Data Entry, Hepatitis, Hepatitis C, Research, Therapy, Cardiovascular
Medical Scientist - 5 Years of Experience - Near 07302
SUMMARY: * Proficient in ARGUS Data Safety submission and Narrative Writing * Thorough understanding and knowledge of MedDRA coding, pharmacovigilance practices for both Clinical Trial and Post marketing AE reporting * Well versed with GVP-ICH guidelines * ECFMG certified medical graduate with strong clinical knowledge * Self-driven, highly motivated medical professional with excellent leadership and organizational skills *...
Tags for this Online Resume: Drafting, Coding, narrative wrirting, ARGUS, MedDRA, Medical Reviewer, Drug Safety, labeling, ICSRs
Clinical Research - 9 Years of Experience - Near 32828
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
Tags for this Online Resume: Policies and Procedures, Monitoring, Patient Care, Protocol, Documentation, Outsourcing, Research, Clinical Research, Consulting, Corel Wordperfect
Clinical Research - 5 Years of Experience
Medical Doctor with Post Graduate training and Diploma in Clinical Research from AAPS Toronto * Over 14 years experience working in clinical environment. * Strong understanding of Clinical Research processes according to Study Protocols ICH/GCP
Tags for this Online Resume: Clinical Research, Management, Protocol, Research, Data Management, Good Clinical Practices, Medical, Clinical Trials, Informed Consent Forms, Study Reports, SOP, Regulatory approval
Project Manager
SUMMARY Experienced IT Software professional specialized in working with clients to understand and implement requirements and applications/systems to provide business analytics and strategic solutions in various roles as a Senior Business Analyst, Senior Project Manager, Senior SFDC Architect, Senior Program Manager/Product Manager and Senior Product Owner. Collaborate with product management, engineering and other cross-fu...
Ideal Companies: program mgnt
Tags for this Online Resume: Inventory, Support, Active Server Pages, Forecast, Forecasting, Oracle, Quality, Quality Assurance, Data Entry, Planning
Microbiologist - 20 Years of Experience - Near 80503
Summary Experienced, Self-motivated and Results-Oriented Quality professional with >25 years in the biotech/pharma and medical device industries. Experience hosting FDA and international regulatory agencies. In depth knowledge of compliance to 21 CFR parts 210 and 211, 21 CFR Part 11, 21 CFR part 820, ISO 13485, ICH Q1A-F, Q7, Q8, Q9, Q10, USP, EP, JP Testing. Knowledge and experience with GxP auditing. Chemical and Microbi...
Tags for this Online Resume: Validation, Lab Management, QMS, Compliance, Pharmaceutical, DS, DP, Research and Development, Microbiology, Manufacturing
Clinical Research
AREAS OF EXPERTISE * Clinical Trial Design * Biologics * Study Management * Medical Devices * Scientific Research * Regulatory Submissions * Program Development * KOL Relationships * Scientific Strategy * Oncology * Regulatory Strategy * Cardiovascular * Investigator Recruitment * Gastrointestinal * International Clinical Trials * Regenerative Medicine * Data Analysis * Surgery
Tags for this Online Resume: Clinical Research, Research, Pathway, Protocol, Regulatory Affairs, Infrastructure, Pharmaceutical, Publications, Selenium, Venture Capital, oncology, phase, clinical, gcp, protocol, trial, pharmaceutical, ich
Clinical Regional Monitoring - 11 Years of Experience - Near 53224
Tags for this Online Resume: clinical, trial, gcp, protocol, pharmaceutical, ich, phase, oncology, monitoring, site management
Toxicologist - 19 Years of Experience - Near 60134
SUMMARY I am a highly motivated individual that is driven to succeed, with proven strategic decision making ability and acute attention to detail, underscored by a career highlighted with numerous promotions and high level positions in successful industry and contract research laboratory (CRO) environments in an international setting. I have had great success at aligning cross-functional research and development teams to su...
Tags for this Online Resume: Analytical Chemistry, Applications, Attention to Detail, Compliance, Data Analysis, Data Management, Due Diligence, Good Clinical Practices, protocol, pharmaceutical, ich, GLP
Chemist - 15 Years of Experience - Near 92881
Experienced with trouble shooting issues in chromatography and other testing procedures resulting in effective and high quality test methods * Maintained daily, weekly, and quarterly checks of instrumentation such as stability chambers and HPLC systems as part of team responsibilities, reducing the need for a separate metrology group Scientist II (Laboratory Technical Services) 2011 Performed remediation activities for exis...
Tags for this Online Resume: Filing, Forth Programming Language, Quality Assurance, Regulatory Affairs, Test, High Performance Liquid Chromatography (HPLC), Instrumentation, Quality, Quality Control, Compliance, pharmaceutical, sop, change control, method validation, cleaning validation, hplc, fda, raw material, in-process testing, finished product, solid dose, research and development, method transfer, protocol, report
Biologist - 1 Years of Experience - Near 02865
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Pharmaceutical, Troubleshooting, Assessments, Microsoft Office, Notebook Computer, Pharmaceutical Industry, Quality, Quality Assurance, Quality Control, pharmaceutical, ich, Formulation development
Clinical Pharmacovigilance/Drug Safety - 2 Years of Experience - Near 29577
COVER LETTER: To whom it may concern: I am a Pharmacist with an equal combination of hospital and retail experience. I have seen many changes in healthcare over the past fifteen years of practice as well as the many pitfalls of a currently flailing economy. The aforementioned dynamics have affected the efficiency and safety of pharmacy. Of my prominent abilities are adapting to differing work environments and the staffing c...
Tags for this Online Resume: drug safety associate, Pharmacist, Medical communications , ICH, Argus, MeDRA, ICU, Chemotherapy, Complaints, Drug Information
