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Online Resumes with "ICH"
•Exacting, highly organized researcher with more than 12 years of combined experience in the pharmaceutical industry and university-based clinical pharmacology settings. •Experienced in investigation of Mechanism of Action of novel immunobiologics in investigator-initiated and clinical studies using disease-related biomarker selection and analyses. •Strong background in designing and conducting studies pertaining to the ...
Ideal Companies: Biotech companies
Seasoned Clinical Research Professional with 10+ years experience in Clinical Research, including, CRA, Lead CRA, and Project Management duties. THerapeutic areas include oncology, endocrine/metabolism, and CNS.
I have completed a Masters program in Biotechnology. I have keen interest in Clinical Research and Regulatory Affairs. I am looking for an entry level Clinical or Regulatory position. I have research site coordination experience in the areas of Rheumatology and Pain research. I am also ICH and GCP certified.
Tags for this Online Resume: CRF writing, patient follow up, administering informed consent form, administering psycometric scales, source documents review, Reporting SAEâ€™s, Pre-screening and recruiting patients, -Submitted documents to the Ethics Committee, Rheumatology, Pain
OBJECTIVE: To obtain a challenging position utilizing my medical education and research background. Continue development of experience in pharmaceutical industry that includes data coordination, statistical analyses, GCP/ICH certification, and excellent verbal and written communication skills. Application of knowledge of clinical trial designs to trial execution in a CRA or project management role
Tags for this Online Resume: oralce, oncology, neuropharmacology biotech pharmaceutical, OBJECTIVE: To obtain a challenging position utilizing my medical education and research background. Continue development of experience in pharmaceutical industry that includes data coordination, statistical analyses, GCP/ICH certification, and excellent verbal and written communication skills. Application of knowledge of clinical trial designs to trial execution in a CRA or project management role
Contribution over 20 years of experience ensuring continuous improvements to deliver manufacturing and quality efficiency, I am writing in response to a Food Safety & Quality Management System and Regulations Affairs opportunity. Able to define, analyze, and improve complex applications, established effective food safety, quality regulatory, sanitation, and operational programs. I bring extensive knowledge, experience, pro...
Tags for this Online Resume: Quality Management Systems, Food Safety Fundamental Specialist, Certified Quality Management, Certified Quality Engineer, SQF Specialist, Lean Manufacturing & Continuous Improvement
Professional Summary Technical/software training professional with successful sales and management experience. Outstanding ability to train novice and experienced users on highly technical content. Skilled in a variety of training settings, modalities and methods, as well as the development of course materials. BS Degree
Ideal Companies: Small company less than 1000 employees
Tags for this Online Resume: Microsoft Software, Adobe Software, Virtual Training, VMWare, FirstDoc, ISI Software, LMS, WWAN, VLAN, RIM, POS, Senior Sales, Sales Management, Contact Mgr Software, Citrix, Remedy, 3G, PDA, UMTS, CDMA, Java, trainer, instructor, Instructor, Trainer, Facilitatator, WWAN, Wireless, WiFi, ILT, VLT, Help, Support, ASTD, PMP, MCT, FirstDoc/Documentum, ISD, ADDIE, Mentor
A visionary, dynamic and effective technical leader with a proven track record of scientific vision, innovation and accomplishment to lead and manage R&D and Engineering teams. Excellent problem-solving skills combined with strong organizational, communication and interpersonal qualities to effectively function across multidisciplinary teams. Highly proactive, results and performance driven to meet and exceed business goals...
Have the experience and the knowledge of the clinical trial processes (start-up through close-out), including FDA regulations
Social/Clinical Trials Research Assistant/Coordinator/Clinical Support Specialist
Tags for this Online Resume: ICH Guidelines, IND Application, Guidance on HIPAA Privacy in Research, Protocol Amendment, Quality Assurance (QA), Serious Adverse Events (SAE) or Serious Adverse Drug Reaction (serious ADR), Source Document, Randomization
To utilize my vast knowledge and theraputic background in an exciting and challenging enviornment.
Tags for this Online Resume: MS Word, MS Excel, MS Outlook, MS Power Point, Adobe, FDA/ICH GCP, Siebel Clinical, Oracle Clinical, Lotus Notes, PHASE FORWARD, MediData Rave, ClinPhone, Master Scope CT, Livelink
Accomplished Regulatory Analyst with expertise in all stages of drug lifecycle management and experience in strategy implementation and submission management, eager to contribute to the success of a progressive organization. Proven success in achieving and exceeding company goals and objectives in all aspects of day-to-day regulatory affairs and quality assurance initiatives. Adept at recognizing and analyzing several the...
To actively work in collaboration with a cohesive clinical development team that values professionalism, process and results achieved in alignment with applicable SOPS, Working Practices, ICH/GCP and Regulations.
Profile: Certified Clinical Research Associate professional with extensive recent focus in CVS research and clinical trials. Combine resourcefulness and problem solving skills with clinical knowledge to consistently deliver improved research and production results. Team player dedicated to quality, continuous improvement and bottom-line objectives. QUALIFICATION HIGHLIGHTS â€¢ Knowledgeable in all areas of research including...