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Online Resumes with "CBER"
Product Trainer
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
Senior Director, Chicago
To obtain a leadership position for regulatory affairs expertise in the pharmaceutical/biotech industry
Tags for this Online Resume: regulatory affairs, pharmaceutical, biotechnology, clinical , manufacturing
Energetic, results-oriented individual with established credibility and respect at FDA and EMA. An extraordinary record which includes the lead and approval on New Drug Applications (NDA) and Marketing Authorization Application (MAA)
Global Regulatory Affairs leader for a combination of RA functions. Provides clear and specific regulatory input using skills(scientist, regulator and lawyer) to provide strategic planning decisions and implementation enabling successful drug approvals. Strong leader, expertise in DD, alignment with business goals, creative, proficient with complex frameworks and integration of abstract concepts in clinical and CMC areas o...
Tags for this Online Resume: Regulatory Affairs, small molecules, CDER, CBER, FDA, EMEA, IND, NDA, CTA, IMPD, proteins, anti-infectives, cardiovascular, pain, oncology, CMC, compliance, communicator, monoclonal antibodies , Biologics, Food and Drug, Global, eCTD, health authorities, alliance management, combination products, Biologics Biosimilars , Director , pharmaceutical , Leadership, Problem solving , Innovation, experienced, IND NDA CTA MAA, business goals , biologics - pharmaceutical , biosimilars
Clinical Research
SUMMARY: * POST-MARKETING REPORTING: Vast clinical experience in reporting post-marketing events in the pharmaceutical industry. * CDM: Acquaintance on clinical data management, pre-clinical and clinical trials (Phase I, II, III and IV) * CLINICAL WRITING & DOCUMENTATION: Create clinical project documents according to the protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard...
Tags for this Online Resume: Ipc, Planning, Protocol, Research, Reuters, Business Planning, Coding, Documentation, Immunology, Information Technology
Quality Assurance Director - 4 Years of Experience - Near 08736
Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...
Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate
Business Analyst - 17 Years of Experience - Near 11725
SUMMARY Business Analyst / Validation Lead / Specialist / IT/QA Compliance Specialist with Pharmaceutical, IT, Manufacturing and Software QA experience: An IT professional with extensive experience in QA/Compliance, Testing, SQA, PM, Validation and Documentation specialties include: * Business Analyst experience consists of specializing in writing business workflow processes and translating them into Business, Functional an...
Tags for this Online Resume: Compliance, Information Technology, Test, Quality, Training, Good Clinical Practices, HP, ISO, Good Laboratory Practices, Manufacturing
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
Compliance Manager - 20 Years of Experience - Near 78006
CAREER SUMMARY Management professional experienced in a broad range of quality control, quality assurance, regulatory and regulatory compliance functions within the pharmaceutical and medical device industry with over 35 years of experience. * Extensive experience in implementing quality systems to conform to regulatory standards to meet state, federal and international requirements. * Exceptional team leadership, auditing ...
Tags for this Online Resume: Manufacturing, Pharmaceutical, Quality, Quality Assurance, Quality Control, Audit, Diagnostics, API, Application Program Interface, Cardiopulmonary resuscitation (CPR)
