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Online Resumes with "Pre Clinical"
Clinical Regulatory Affairs - 20 Years of Experience - Near 55311
Summary of Specialized Skills * Design, development and conduct of device based Clinical and Pre-Clinical Research projects. * Experience in writing various clinical documents, including protocols, CERs, reports, research findings. * Design and Implementation of various Pre-clinical trials for pilot studies of various implantable technologies. * Management of scientific/animal studies and clinical projects. * Hands-on exper...
Tags for this Online Resume: Imaging, Cardiology, Integrated Development Environments, Management, Data Management, PACEMAKER, Pacemakers, Research, Clinical Research, Publications
Market Research Analyst - 17 Years of Experience - Near 77546
Michael is an accomplished Healthcare Management Expert bringing to the table an expansive career spanning over 17 years of experience with an outstanding track record of leading teams in a fast-paced rapidly changing business & technology environments; managing internal business & marketing expertise to enhance operational efficiencies in the business. He possesses a successful track record of leading, motivating, and insp...
Tags for this Online Resume: Product Development, Consulting, Market Research, Research, Benefits, C Programming Language, Documentation, Forecasting, Health Care Industry, Licensing, pharmaceutical
Quality Engineer - 15 Years of Experience - Near 10312
Summary of Qualifications * Provide validation services for pharmaceutical clients to be compliant with FDA regulations utilizing CSV methodology * Professional with a strong background in validation, quality, information technology, and chemistry domains for pharmaceutical and medical device industry * Proven knowledge of FDA regulatory requirements, including cGxP, GLP, GMP, Sarbanes-Oxley (SOX), 21 CFR 210/211, 21 CFR 58...
Tags for this Online Resume: Services, Data Migration, Legacy, Quality Assurance, Assessments, Audit, Management, Quality Management, Pharmaceutical, Quality, validation, CSV, business analyst
Quality Assurance Director - 11 Years of Experience - Near 07076
SUMMARY Detail oriented and results focused professional with experience working in a global pharmaceutical company, research and development with multiple manufacturing sites and regulatory authorities worldwide. Possess clinical education, drug development and strong analytical background and solid understanding of the ICH, FDA, EMA Regulatory Guidelines as well as other regulatory body's guidelines and CMC requirements t...
Tags for this Online Resume: Good Laboratory Practices, Microsoft, Microsoft PowerPoint, Microsoft Visio, Policies and Procedures, Protocol, Quality, Quality Assurance, Research, Research and Development
Senior BD/VP Business Development -30+ years selling services to pharmaceutical and biotechnology companies
Summary: 1991 to Present (please see Chronology Section below) Serve as an effective business developer & manager of sales teams (e.g. consultant when not an employee) for many firms providing services to pharmaceutical companies. Currently providing value-added business development consulting services to CRO clients to enable them to acquire new business with pharmaceutical/life science companies. I have also held employme...
Tags for this Online Resume: Biotechnology, Pharmaceutical, Pharmaceutical Industry, Clinical Research, Research, Consulting, Due Diligence, Managed Care, Planning, Strategic Planning
Quality Assurance Specialist - 14 Years of Experience - Near 07871
SUMMARY Manager and Project Coordinator of Scientific Systems with over 25 years of experience in the Pharmaceutical and Scientific field. Well versed in FDA Regulations for scientific data collection validation. Proven ability to work in coordination with Clients and Project Teams to conform to FDA Regulations. Ability to meet deadlines, working independently or as a team member. Expertise includes: * Instem Centrus Suite ...
Tags for this Online Resume: Pathology, Toxicology, CVS, Pre-clinical, Validation, GLP, Legacy, Project Leader
Biologist - 20 Years of Experience - Near 02459
Summary: Experienced cell/molecular biologist with background in bioanalytics, cell-based & ligand bind- ing assay development/validation, early discovery of therapeutic biologics and anticancer drugs. Expert in Mesoscale Discovery MSD multiplex/singleplex platform. Highly motivated, analytical, creative worker. Effective independent researcher and a team contributor. Research Expertise Biomarker analysis, PK & PD experienc...
Tags for this Online Resume: ELISA, Cancer, Pharmaceutical Industry, Electrophoresis, Statistical Analysis, oncology, Mesoscale Discovery, assay development/validation, Western blot, biologics, cancer, mammalian cell culture, ligand binding, DNA/RNA
Biophysicist - 20 Years of Experience - Near 21791
As a leader of projects in Pharma discovery and pre-clinical efforts, I have managed functional activities and provided scientific direction from drug discovery concept to FIH. I contributed to an IND for the project I led. I am an inventor on the filed US patent. In June 2017, the second patient was dosed with this exploratory medicine. In my current and previous roles, I have had the opportunity to coordinate internal an...
Tags for this Online Resume: Immunology, Management, Research, Data Management, Process Improvements, Pharmaceutical Industry, oncology, pharmaceutical, project leader, project manager
Clinical Research - 15 Years of Experience - Near 02131
Pre-clinical. Animal models.
Tags for this Online Resume: gcp, phase, sap, trial
Clinical Research
SUMMARY: * A lifetime of working in the Healthcare Industry having served as a clinician, teacher, manager and researcher in acute and chronic care environments, transitioning into pharmaceutical, medical device industries and government agencies including National Institute of Health, National Institute of Child Health and the Department of Defense: Aviation-Space-US Air Force * Respiratory Therapy, across the human lifesp...
Tags for this Online Resume: Ventilators, Critical Care - Neurology, Critical Care - Respiratory, Home Care, Monitoring, Neurology, Acute Care, Cardiology, Anesthesia, Billing
Statistical Programmer - 5 years Experience - US
Summary * Certified Base Programmer for SAS 9 with 5+ years of biostatistical programming experience in CRO, hospitals, pharmaceutical, and healthcare industries. * Involved in drug development process with experience in analyzing, reporting, and reviewing pre-clinical/clinical trial data. * Good understanding of FDA submission (IND, NDA) process, clinical protocols, CRFs, CDISC (SDTM, ADaM), 21 CFR Part 11, GCP, and IRB gu...
Tags for this Online Resume: SAS, Proc, Programming, Statistical Analysis, SAP, Research, Statistics, Structured Query Language, Management, Test
Contract Medical Writer
Summary Work Experience: Strong background in medical writing and biotechnology product and services development, with a solid publication record in the peer-reviewed medical literature in addition to biotechnology analyst articles-an unusual combination of medical writing expertise, analytical skills, data analysis, management experience, and medical knowledge. Participate in pre-clinical, clinical, and commercial research...
Tags for this Online Resume: Business Development, Cancer, Clinical Research, Medical Writer, regulatory science, biologics, drugs, medical device