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Online Resumes with "CDER"



The Tiger w/ Sales

High energy sales professional with exceptional interpersonal, communication and leadership skills. Resourceful, creative, loyal

Ideal Companies: separated by commas., General Motors, Ford, General Electric, Chevron

Tags for this Online Resume: Typing

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

Featured Profile

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

Featured Profile

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

Life Scientist - 20 Years of Experience - Near 20721

Summary * Project Officer and Work Assignment Manager human health toxicologist in the in the U.S. Environmental Protection Agency's (USEPA) Office of Water (OW) to support agency products registration and other regulatory activities * Developed human health benchmarks for registration/regulation of drinking water and environmental contaminants for the USEPA * Developed multivariate computational toxicology in silico QSAR m...

Tags for this Online Resume: Risk Assessment, Management, Toxicology, Integrate, biologist, toxicologists, Assessments, Cancer, Data Analysis, Database, ESA

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)