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Online Resumes with "regulatory documents"



Automation & Process Controls Engineer - 20 Years of Experience - Near 27569

Over twenty years equipment and process design, installation and testing of process control and automation systems used across various industries the majority of which are pharmaceutical and food; Fortune 100 & federally regulated corporations. Extensive knowledge of multiple PLC platforms, SCADA programming, MSSQL, InSQL, and RSSQL database designs, implementations & management, InBatch, CDC’s & Wonderware’s Overall Equipm...

Tags for this Online Resume: Automation, Process Controls, Project Manager, I, Pharmaceutical, Biotech, PLCA, SCADA

Worldwide Director of Regulatory Affairs

Strategic Regulatory Affairs Professional with diverse and progressive experience leading growing or established companies in the pharmaceutical, biotech and medical device industry providing global strategic regulatory direction for both new and existing products, as a primary contact facilitating preparation of international regulatory documents. Advances the development of knowledge, products, people, collaboration, c...

Tags for this Online Resume: Product Registration, CMC, International Submissions, Global regulatory, BLA, INDs, Orphan Drugs, Project Management, Bilingual, International regulations

Marketing Professional with exceptional Clinical Background

Marketing Professional with exceptional Clinical Background

Ideal Companies: Johnson & Johnson, Wyeth, , Sanofi-Aventis, Merck, GSK

Tags for this Online Resume: Clinical Trials/ Study Manager

Featured Profile

Research

To obtain a challenging position within the Pharmaceutical industry or medical devices industry that will allow me to use my experience to play a key role in Clinical Research studies and projects, and/or product development with medical devices.

Tags for this Online Resume: Clinical Pathology, laboratory method development, IQ, OQ, PQ, instrumentation, validation of medical devices, Regulatory, GLP, GCP, IRB, TMF, Project Manager, Documentation Specialist, Scientist, Archives

Ph.D. Drug Discovery Biologist - 17 Years of Experience - Near 02478

• Accomplished in all stages of drug discovery from target selection to clinical nomination and first-in-human studies • Matrix team leader and collaborator in multidisciplinary teams with internal and external organizations • Assay development, biomarker discovery, and evaluation of preclinical and clinical drug candidates • Strong background in molecular biology, cellular and in vivo pharmacology, neurodegeneration • Writ...

Tags for this Online Resume: Neurodegeneration, pharmacology, Boston, biomarkers, drug discovery, molecular biology, in vivo, Alzheimer

Executive Vice President - 20 Years of Experience - Near 33707

Tags for this Online Resume: Nutraceutical, Global manufacturing, Operational strategy, claim substantiation Nutraceutical, Regulatory documents, 1 Billion dollars in global sales

Featured Profile

Using the knowledge, skills and abilities to help your organization steer towards continuous development and leadership

My goals and aspirations I have for my career is to build on my background in academic interventions, health services and research to improve education and/or health services for the community that I am serving. Using my skills in grant writing, project management, program evaluation, I am also willing to accept career opportunities at mid level and develop further skills and knowledge that will help lead any non for profit...

Ideal Companies: McGraw Hill Foundation, Bill and Melinda Gates Foundation, International Student Volunteering, Carnegie Foundation,

Tags for this Online Resume: Program Director, Education Director, Healthcare Administrator, Physician Liaison, School Development Director, Regulatory Compliance Director, Program Associate, Educational Specialist, School Director

Featured Profile

Director, Business Development Clinical Research IRB- 14 years Experience- Seattle/Portland/Denver

Senior marketing and client development executive with 14 years experience in clinical research. I am looking for continued growth as a research professional leading project teams and staff in support of strategic business goals. As a leader in the development and maintenance of productive client relationships, I have been recognized for expanded customer utilization of products and services with a focused customer-centric...

Ideal Companies: Quintiles, Huron Consulting, Roche, Genentech, PharmaLink Consulting, Icon, Covance, PRA International, AAHRPP

Tags for this Online Resume: Account Management, Client Services and Develpment, Marketing, Project Management, Presentations, Budgeting, International Business, Team Leadership, Process Improvement, Training/Development, Performance Management, Business Development, Operations Management, Branding, Vendor Relations, Clinical Research Regulatory Compliance, Federal Regulations

Clinical In-house Monitoring

Tags for this Online Resume: documentation specialist, records management, clinical trial coordinator, essential regulatory documentation, inhouse clinical trial associate, clinical research support

Clinical Regulatory Affairs - 13 Years of Experience - Near 19711

My background includes 13 years’ experience in the Pharmaceutical Industry at AstraZeneca Pharmaceuticals in Global Regulatory Submissions and Life Cycle Management of Regulatory documents. This includes 6 years’ experience as a Project Manager for Regulatory Global submissions. As a Project manager within the Submission Management Group, I provided expertise on global submission compilation and published electronic submiss...

Tags for this Online Resume: Newark, DE, Life Cycle Management, Regulatory Global Submissions, Pharmaceutical Industry, RSS Application, eCTD Publisher, electronic submissions, Regulatory Publisher, Management, Cardiovascular, Document Management, Legal, Pharmaceutical, Project Management, Publishing, Quality Assurance

Manager - 15 Years of Experience - Near L4X 2J3

. I have recently done Diploma in Business Management, with honours; from Canadian Business College which adds value to my skills for the advertised job posting. My analytical skills have contributed to reduction in wastages by 50% and re-works were reduced by 60%. Creativity and innovative skills, and interest in research and development helped me increase company sales by 30% as a result of new product development. Improv...

Tags for this Online Resume: Human Resources, Financial Analysis, Compensation , Operations Management, Microsoft Office Suite, ERP Softwares, Process evaluation, Training, Apple, Customer Service, Inventory, Sales, Derivatives, Security, HR