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Online Resumes with "FDA ICH"
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.
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...
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
Can undertake most of the tasks and works independently. Very much focussed on the timelines and quite goal tending. Willing to help others in their prioritized tasks. Excellent planning, design and implementation. Highly experienced in writing reports and data analyses.
Clinical Supply Operation, Edison, NJ - 8+ Years of experience in pharmaceutical R&D, Clinical supply operations. Knowledge and experience in GMP, GCP and FDA/ICH guidelines. Good experience of computer programming and use of MS Suite of Applications, Dat
Proven expertise in managing teams, streamline project paths encompassing an understanding of scientific data, analysis and interpretation of results, clinical developability and commercial viability of projects.
RAFAEL GOMEZ GAITAN, MD, CRA 5956 S. ZANTE WAY AURORA, CO 80015 PHONE 303-507-8959 E-MAIL: RAFAEL_G_GAITAN@YAHOO.COM To Whom It May Concern: I am seeking a position that will allow my skills in clinical research and medical training to support, as a Clinical Research Coordinator, a medical facility in the treatment of patients or research activi...
Ideal Companies: Clinical Research
Tags for this Online Resume: Clinical
I have a hands-on experience interacting with suppliers, internal customers, and subject matter experts to ensure thorough evaluation and accuracy of discrepancies and investigations, identifying root cause, coordinating corrective and preventive action plans, writing summaries, and reviewing reference documents. I am experienced in change control process for externally initiated material changes in accordance with cGMP, U...
Objectives: To seek a growth opportunity in US pharmaceutical industry, a role in clinical research areas such as Drug Safety/Pharmacovigilance, Medical Writing, and Medical affairs.
Tags for this Online Resume: drug safety, pharmacovigilance, medical writing, clinical research, clinical trial or study, managerial/supervisory experience, senior level in global pharma company, risk management, US work authorization, GCP, FDA, ICH, detail-oriented, results driven, drug , medical , safety, clinical, writing, FDA, GCP, ICH, senior, regulatory, responsible, pharmaceutical
As an established Quality Control Manager, I have extensive experience in quality assurance, instrument qualification, procedure writing, analytical methods development, transfer and validation. I Possess expertise with FDA, ICH and EU requirements for pharmaceutical, drug substance, drug product and device testing. I Collaborate effectively with outside vendors and internal groups including assay development, manufacturing...