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Online Resumes with "ICH Guidelines"
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...
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.
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...
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)
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...
Areas of Expertise * ICH Guidelines * Time Management * Strategic Analysis * Clinical Research * Medical Review/ EMR Medical Coding * Interpersonal Communications
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...
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...
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...