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Online Resumes with "ICH Guidelines"

Clinical Research Associate

 John is detail oriented, highly dependable previous site monitor and study coordinator with 4 years and 6 months experience, including assistant project management in the pharmaceutical development industry  He has attained knowledge and experience in 4 years of hands on provision of care for elderly and disabled persons assisting them with activities of independent daily living as well as dealing with transitional aspec...

Ideal Companies: Alcon, Merck, Wythe, Pfizer, Bristol-Meyers Squibb, Covance

Tags for this Online Resume: in-house monitor, Clinical Research Associate

Featured Profile

Pharmaceutical Analyst, 7year Experience in drug analysis by HPLC, GC, Dissolution, India

I am Research Scientist having 7 years experience in analysis of Drug Substance and Drug Products by HPLC, GC, Dissolution and other wet analysis. I am expert in handling instruments like HPLC, GC, Dissolution App., Auto titrator , analytical Balance, pH meter etc.

Ideal Companies: I do love to work at companies like Watson, Actavis, Teva and good reputed pharmaceutical companies.

Tags for this Online Resume: Salt Lake City, HPLC, Drug Substance, Validation, Research Scientist , Stability Studies

Clinical Pharmacovigilance/Drug Safety

Tags for this Online Resume: MD, ARISg, FDA & ICH guidelines, MedDRA, WHO-DD, iMedidata & RAVE

Formulation Scientist, Bay Area

Highly accomplished R&D professional with over 17 years of cumulative Analytical, Formulation and Management experience. Technical background includes recognized strengths in development of high concentration, stable liquid and lyophilized drug product formulations, biophysical and chemical characterization, Life Cycle Product Management, and compatibility studies for Preclinical Dose Administration. Experience includes des...

Tags for this Online Resume: Formulation Scientist, Fusion Proteins, Monoclonal antibodies, Liquid formulations, Lyophilized Formulations

Clinical Research - 7 Years of Experience - Near 08820

Tags for this Online Resume: Clinical Monitoring, Prestudy visit, Study closeout, SOPs, Ich Guideline, FDA requirement, Study documents

Clinical Pharmacovigilance/Drug Safety - 5 Years of Experience - Near 39056

Tags for this Online Resume: Argus 7.0.3, Adverse event reporting, MedDRA conventions, Microsoft Office, ICH-Guidelines, Communication skills, Arisg

Clinical Quality Assurance - 20 Years of Experience - Near 94403

QA/QC experience working with FDA ICH and Japanese regulations 21 CFR reviewing Writing editing submission documentation SOPs Protocols Reports. Product/Project analytical requirements evaluation budget in-house vs. out-source estimation. Upgrading of R&D laboratories to GLP/GMP level.

Ideal Companies: small start-up company

Tags for this Online Resume: methods transfer validation, phase I, II, III protocols and reports, GMP GLP, Laboratory management, hiring training budgeting, FDA ICH regulations, validation monitoring transfer, medical devices, Consulting, Document Review, Documentation, DSC, High Performance Liquid Chromatography (HPLC)

Clinical Regulatory Affairs

Professional, and is currently employed as a Regulatory Specialist. My attributes includes: multi-tasking with the ability to work independently and with a team; highly detail-oriented; good organizational and time management skills; ability to develop good customer and colleague relations; good management and interpersonal skills; solution-oriented; self-starter with a positive attitude and good communication skills. My sk...

Tags for this Online Resume: Clinical Research, Study Start-up, CCRC, CRA Experience, Leadership , GCP, CTMS, Research, Medical, Blood Bank, Telemetry, Nursing, Training, Business Development

Medical and Scientific Consultant

Areas of Expertise * ICH Guidelines * Time Management * Strategic Analysis * Clinical Research * Medical Review/ EMR Medical Coding * Interpersonal Communications

Tags for this Online Resume: real world evidenc medicine, Clinical Research, Data Management, Documentation, icd 9/10 coding, Management, Medical, Pharmaceutical

Biostatatician - 5 Years of Experience

Profile A multilingual result-driven biostatistician and SAS programmer with more than 15 years of professional experience. Broad experience of data manipulation in medical research, pharmaceutical research, clinical trials. Thorough knowledge of drug development processes at CROs, ICH guideline and GCP certificate. Proficient at SAS programming with 8 years of experience in data analysis, statistical modeling, data prepara...

Tags for this Online Resume: Active Directory Application Mode (ADAM), Data Analysis, Medical, Statistical Analysis, Programming, Protocol, Research, SAP

Medical Office Manager - 1 Years of Experience - Near 02120

Seeking a position to utilize my skills and abilities in the corporate sector that offers professional growth which is being resourceful, innovative and flexible. Knowledge of ICH guidelines and safety reporting requirements, good manufacturing practices (GMP), good laboratory practice (GLP) and good clinical practices (GCP). Understanding of FDA regulations and knowledge of IND, NDA, BLA, Drug Master File (DMF), 510(k) and...

Tags for this Online Resume: Boston, GLP, GCP, FDA Regulations, Medical Device

Clinical Research - 6 Years of Experience - Near 75287

PROFESSIONAL SUMMARY: A CRA with strong eye for detail and exceptional ability to interpret and follow instructions Possesses the ability to collect accurate data in line with client specifications excellent analytical and organizational skills knowledgeable in FDA regulations, GCP/ICH guidelines, seeking to join an organization that makes research subjects' safety its first priority. CORE QUALIFICATIONS: * Over 5 years exp...

Tags for this Online Resume: Management, Clinical Research, Data Management, Protocol, Research, Assessments, Forth Programing Language, Good Clinical Practices, Monitoring, Training