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Online Resumes with "ICH "
Chief Operations Officer - 11 Years of Experience - Near 92122
SUMMARY of QUALIFICATIONS Available for remote project management and San Diego based roles leading business, clinical, compliance structures. Clinical and regulatory catalyst establishing organizational, technological and scientific intelligence, strategies and resources to ensure a profit based business and marketing environment. * Synergistic Scientific and Business acumen, proficient analytical, technical and interpreti...
Tags for this Online Resume: IVD/Medical Device, Pharmaceutical Research, RNA/DNA, Clinical Research, Operations, IND, Regulatory, Project Management, Oncology, AI, cNLP, Genomics
Director
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 Regulatory Affairs - 20 Years of Experience - Near 53143
Summary 30 plus years in the Medical Device and Pharmaceutical industry. Extensive expertise in Supply Chain, Customs Compliance (import and export), Test methods and Process Validations, Technical product development and support, GTIN and UDID process for organizations that meet GS1 standards. Experience in Customs Compliance and Quality Systems Regulations as well as domestic and international standards. Core competencies...
Tags for this Online Resume: Customs Compliance, Scrum Master, Regulatory Affairs, Validation, HR, Quality, Compliance, Hepatitis, Planning, Quality Assurance, Project Manager, Medical devices
Clinical Regulatory Affairs - 5 Years of Experience
Profile Regulatory Affairs Specialist with more than five years of experience in the pharmaceutical and biotechnology industries, implementing global regulatory filing strategies. Education in biotechnical engineering with deep knowledge and practical skills in managing the submission process from start to end, monitoring and tracking information, communicating with colleagues, managers and subject experts for efficiency an...
Tags for this Online Resume: Manufacturing, Packaging, Pharmaceutical, Regulatory Affairs, Biotechnical, Filing, Management, Medical, Medical Devices, Microsoft Office
Medical & Clinical Laboratory Technician - 6 Years of Experience - Near 60706
SUMMARY OF QUALIFICATIONS * BA and Masters Degree in Bioengineering and Biotechnology from Poland * Motivated team player, detail oriented, result focused with excellent time management and people skills * Proficient in MS-Office (Word, Excel, ) and the internet * Strong knowledge of anatomy and physiology, medical terminology, ICH GCP guidelines * Proven ability to work efficiently and effectively under pressure * Versatil...
Tags for this Online Resume: Administrative Assistant, Documentation, Patient Care, Scheduling, Therapy, Management, Pathology, Protocol, Satellites, Polish/English
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
Clinical Regional Monitoring - 10 Years of Experience - Near 20912
20/20, Addis Ababa University (CRO), Addis Ababa, Ethiopia, March 2005 to July 2006 Senior Clinical Research Associate - Opthalmology Studies, National Blindness, Low-Vision & Trachoma * Oversaw $3.5M study across 14 regional states to explore blindness, low-vision, and trachoma demonstrated sharp organizational skills in managing team of clinical data managers verifying data, and performing systematic networking of databas...
Tags for this Online Resume: Clinical Research, Research, Protocol, Collection, Critical Care - Neurology, Management, Neurology, Oncology, Quality, Quality Assurance
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
Clinical Research - 20 Years of Experience - Near 33467
SUMMARY A highly experienced and innovative clinical research professional with over 25 years of progressive and comprehensive experience as a study coordinator, SMO assistant site director and associate director successful management of multiple projects, mega trials and teams simultaneously while meeting or exceeding specified timelines in a remote environment. Most recently created and trained a dedicated Informed Consen...
Tags for this Online Resume: Management, Inventory, Pathology, Research, Accounting, Clinical Research, Documentation, General Accounting, Health Insurance Portability And Accountability Act, ICH
Clinical Data Management - 1 Years of Experience - Near 07302
Tags for this Online Resume: Data Management, Clinical Trial, ICH-GCP, SOP, Clinical Data support, Clinical Trial associate, Entry level
Scientist
SKILLS SUMMARY * Authored technical reports, research manuscripts, SOPs, IACUC and IRB review of protocols. * Knowledge of GLP, ICH, FDA and NIH regulations, CITI training. * Reviewing, Editing, QC, and Finalization of documents and research grants. * Extensive knowledge of MS-Word, Excel, PowerPoint and Microsoft Access. * Proficiency in GraphPad Prism, FlowJo, Sequencher and Geneious. * In-depth scientific knowledge of Im...
Tags for this Online Resume: immunology, virology, clinical research, regulatory
Business Analyst - 2 Years of Experience - Near 32301
Biotechnology and a Business Professional seeking an opportunity in the field of Regulatory Affairs
Tags for this Online Resume: FDA, ICH, Auditing, Complaint files, Microsoft Office, Microsoft Visio, HIPPA Regulations and Compliance, Drug Regulatory Affairs, Business and Requirements Gathering and Analysis, Process Mapping and Improvement, Microsoft Project Professional
