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Online Resumes with "ICH Guidelines"

Clinical Research

PROFESSIONAL SUMMARY: Licensed Pharmacist from India with Masters in Pharmacology. Over 7+ years of experience in the Pharmaceutical industry with focus in Pre-clinical and clinical trials and a strong understanding of cGMP, GCP, FDA regulation and ICH guidelines. Have an Extensive knowledge as a Quality Assurance officer and outstanding interpersonal skills with a track record of establishing positive relationships with cu...

Tags for this Online Resume: Clinical Research, Email, Management, Project Management, Project Manager, Protocol, Research, Canvas

Clinical Research Associate

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. AREAS OF EXPERTISE * Management * Interview candidates and either make a selection decision or recommend individuals for hire. * Able to manage multip...

Tags for this Online Resume: Clinical Research, Research, Accounting, Acquired Immune Deficiency Syndrome (AIDS), Advertising, Amazon Elastic MapReduce, Audit, Basic First Aid, BLS, Budgeting

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 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

Chemist - 13 Years of Experience

SUMMARY OF QUALIFICATIONS: * Strong organizational and technical skills, highly efficient a quick learner. * 13+ Years of experience with Analytical Testing within GMP environment. * Understands and complies to ICH guidelines, cGMP, GLP, and FDA regulations. * Very enthusiastic and motivated in learning new instrumentation and methods. * Work effectively under high pressure environment and never compromise with ethics and q...

Tags for this Online Resume: Quality, Quality Assurance, High Performance Liquid Chromatography (HPLC), Documentation, Instrumentation, Software, Test, Troubleshooting, 5S, Documentum

Life Scientist - 8 Years of Experience - Near 27617

Summary Ph.D in Pharmaceutics with extensive experience in analytical method development, method transfer and validation for Small and Large molecular API, in a GMP environment. Specialized in mass spectrometry/LC-MS method development and troubleshooting. Good knowledge of the GMP, GLP, SOP practices, the USP, EP, NF, FDA and ICH guidelines. Proven problem solver, motivated team leader and excellent communicator Qualificat...

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), ELISA, protein, Protocol, LC-MS, MASS, API, Process Improvement, Application Program Interface, FORMULATION, QC, ANALYTICAL, pharmaceutics

Clinical Research - 20 Years of Experience - Near 20882

Summary: Over 16 years managing clinical trials and data collection activities. Manage as Point of contact for sponsors, project teams, and investigational sites to facilitate clinical studies Phase I-IV. Responsible for the review and approval of case report forms, electronic data capture systems, review of protocols, implementing study procedure manuals, and monitoring plans. Additionally manage site selection, study exec...

Tags for this Online Resume: Collection, Quality Assurance, Test, Process Improvement, Project Management, Project Manager, Business Requirements, Clinical Research, Data Entry, Filing


Dedicated and Strategic QA Professional with more than fifteen years of progressive experience in both large and small pharmaceutical companies both US based and international. Extensive experience in development through commercialization of solid oral dosage products. Comprehensive knowledge of cGXP and ICH guidelines. Leader of process and manufacturing compliance, document control programs, QA analytical sciences, vali...

Tags for this Online Resume: Internal and External Audits, Vendor Management, Quality Systems, CAPA, Customer Complaints, Chemistry Machine Control

Clinical Project Manager-6 years-France

I supervised the development of several clinical projects in different therapeutics areas and in different countries (France, England, Italy, USA and Canada). I coordinated the clinical activities in respect with the budget, timeframe and regulations (SOPs, FDA-GCP and ICH guidelines). I trained CRAs, site investigators and CROs to ensure study protocol comprehension and compliance (initiation visits, co-monitoring). I plan...

Tags for this Online Resume: clinical project, oncology, dermatology, cardiology

Biostatatician - 4 Years of Experience - Near 15217

SUMMARY OF QUALIFICATIONS * Four years of experience performing analyses for clients to help in grant submissions, publication of peer-reviewed manuscripts, and abstracts * Expertise in the analysis of high dimensional data * Proficient with statistical software SAS and R * Excellent oral and written communication skills * Apply a wide range of statistical methodology to analyze data from wide variety of fields as a consult...

Tags for this Online Resume: Clinical Study Reports, Communication Skills, Data Analysis, SAS, ICH, Microsoft, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Presentation Skills, R, Philadelphia, high dimensional, consulting

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