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Online Resumes with "Regulatory Affair"
Senior Manager / Director of Quality
Summary of Qualifications: * Twenty Eight +, years of experience in molecular biology, protein chemistry, biotechnology sciences, QC management, Regulatory Affairs, and Quality Assurance. * Experienced in establishing and directing groups, project management, assay development, personnel training and supervision, quality control, and regulatory cGMPs. * This combination of skills affords a unique opportunity to guide the Qu...
Tags for this Online Resume: Audit, Compliance, Biotechnology, Due Diligence, Licensing, Insurance, Microbiology, Benefits, Documentation, Chemistry
Clinical Regulatory Affairs - 4 Years of Experience - Near 55434
SUMMARY OF QUALIFICATIONS: An adaptive and highly organized professional seeking a challenging opportunity in the IT space. Experienced change agent, constant problem solver, always watching for process automation and improvement opportunities on behalf of her clients. High learning curve Analytical for technical systems software mechanical and electrical Teamwork Goal Setting and Team Empowerment
Tags for this Online Resume: Documentation, Technical Writing, Packaging, Pharmaceutical, Process Improvement, SAP, User Documentation, Adobe, Adobe Illustrator, Audit
Production Technician
Microbiologist - 20 Years of Experience - Near 45066
Summary of Experience William H, Fleming, III, PhD has thirty five plus years in the plasma, biopharmaceutical, medical device, contract manufacturing and hospital based clinical industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished plasma derived drug products, medical devices, small molecule sustained release microsphere based drug products, biological prod...
Tags for this Online Resume: Regulatory Compliance, Regulatory Affairs, Regulatory Compliance Auditing, Analytical Chemistry, Method Validation, Process Validation, Microbiology, Standard Operating Procedures, CMC BLA 510K, Policies and Procedures
Clinical Research - 10 Years of Experience - Near 18901
Summary: * Several years of clinical experience in the industry with excellent knowledge of drug development in different therapeutic areas including oncology, immunology, vaccines, metabolism and biosimilars. Solid clinical practice experience. * Many years of Drug Safety, pharmacovigilance, risk management and epidemiology experience * Experience interfacing with health authorities (worldwide), institutional review boards...
Tags for this Online Resume: Oncology, Protocol, Regulatory Affairs, Risk Assessment, Management, Risk Management, Risk Management Activities, Complaints, Documentation, Hematology, Medical Affairs, Clinical Development
Environmental Engineer - 20 Years of Experience - Near 26542
SUMMARY Environmental manager and regulatory compliance specialist with 28 years of experience, the last nine primarily focused on Marcellus and Utica shale gas drilling. Worked as a Regulatory Compliance Director for a major E&P gas company, construction supervisor, environmental compliance manager, corporate environmental engineer, consulting engineer, solid waste project manager and consulting firm branch manager. Respon...
Tags for this Online Resume: Compliance, Management, Billing, Regulatory Affairs, Environmental Issues, Quality, Quality Assurance, Quality Management, Test, Assessments
Clinical Regulatory Affairs - 3 Years of Experience - Near 95112
Detail-oriented dedicated team player with strong regulatory & management skills focused in Biomedical/Biotechnology industries. Seeking new opportunitites in Biomedical/Biotechnology industries.
Tags for this Online Resume: Audit, Biotechnology, Management, Research, Bengali Language, C Programming Language, Complaints, Compliance, DBMS, Dialysis
Clinical Regulatory Affairs
Summary of Qualifications: Dedicated Project Management, Regulatory Affairs, and Quality Assurance Professional with global experience working in a regulated environment. Proficient at interacting across numerous functional areas and with all levels of Management. Knowledgeable in global regulatory processes, strategies, and requirements. Capable of seeing multiple complex projects through to successful outcomes. Excellent ...
Tags for this Online Resume: Management, Project Management, Regulatory Affairs, Corrective Actions, Pharmaceutical, Audit, Quality Assurance, Illinois
Health Technologist - 4 Years of Experience - Near 07310
Tags for this Online Resume: Electronic Data Interchange, Insurance, Procurement, Protocol, Quality Assurance and Regulatory affairs, New york city, Business analyst in Healthcare, Claims, HIPAA, Healthcare IT, Project coordinator
Executive Sales Representative and Special Needs Advocate
SUMMARY Executive Sales Representative and Special Needs Advocate with 19 years experience in the medical industry. Successful performance in pharmaceutical sales, special needs planning, regulatory/medical writing, production management and speaker development. Product knowledge in multiple therapeutic categories. Well-developed skills in communication, project planning, problem solving, leadership, prioritization, and org...
Tags for this Online Resume: Special Needs Planning, Medical Writer, Networking, Genetics, Clinical Research, Pharmaceutical, Quality Assurance, Sales, Marketing
Biochemist
Summary of Qualifications: Scientist with 20+ years of combined experience within the In-Vitro Diagnostics Devices and Biotech Industries with success as a Bench Scientist in completing a project ahead of time, and co-authoring a report which resulted in a 3 million bonus for Gen Probe.
Tags for this Online Resume: • In-Vitro Diagnostics Medical Devices, • Regulatory Affairs, Scientific Writing, Annual Reports, Research, Manufacturing, Troubleshooting, • Pre-Sub, FDA, 510(k), PMA, • Experimental Design, • Monoclonal Antibodies, Medical Devices, • Nucleic Acid Amplification, • End-Point/Real-Time PCR, qPCR
