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Online Resumes with "regulatory documentation "
Quality Coordinator - 7 Years of Experience - Near 27703
Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Compliance, Electrophoresis, ELISA, Good Laboratory Practices, HIV, Management, Medical, FDA Guidelines, GCP Guidelines, Regulatory Documents, Cardiovascular Clinical Research, Oncology Clinical Research
Chemist - 4 Years of Experience - Near 17602
Professional Summary * Over 2+ years experienced in the field of Pharmaceutical Quality Assurance. * Ability to handle analytical method, cleaning and process validations. * Experience in issuing of line clearance at every step of batch manufacturing * Provide support to the various divisions for effective and efficient implementation of the Quality Management System. * Experience of preparing and analyzing information for ...
Tags for this Online Resume: Documentation, Forth Programing Language, High Performance Liquid Chromatography (HPLC), HVAC, Manufacturing, PDC, Quality, Quality Assurance, Test, Communication Skills
Editor
My bench research career focused on steroid hormone receptors and steroid resistance in cancer chemotherapy models for studying mechanisms underlying autoimmune kidney failures and developmental heart defects. You will find my significant research contributions through various presentations at scientific conferences and seminars and publications in peer review journals. My clinical research experience focused mainly on regu...
Tags for this Online Resume: Cancer, Reviewing, proofreading, Documentation, Medical, Therapy, Chemotherapy, Oncology, Insulin, Science, editing, rewriting
Clinical Research - 1 Years of Experience - Near 07011
As Clinical Trails Associate and e-TMF expert, I have a solid expertise in the New Drug development process as well as a strong document management skills and experience with essential regulatory documents detail oriented, organized, quality driven and able to work in a team environment both national and international.
Tags for this Online Resume: Management, Data Queries, Metadata, CTMS- TMF
Clinical Regulatory Affairs - 13 Years of Experience - Near 19711
My background includes six years experience as a Project Manager for Regulatory Global submissions, as well as Life Cycle Management of Regulatory documents. As a Project Manager within the Submission Management Group, I provided expertise on global submission compilation and published electronic submissions compiled in RSS Application (eCTD) in accordance with Health Authority guidelines and departmental standards.
Tags for this Online Resume: Newark, DE, eCTD, RSS Application, Regulatory Publisher, Regulatory Submissions, Document Management, Legal, Management, Project Management, Publishing, Quality Assurance, Test, eCTDXpress
Clinical Research - 16 Years of Experience - Near 94547
SUMMARY of QUALIFICATIONS 16 years of experience as a Clinical Research professional in Biotech and Pharmaceutical industries. Well-rounded skill, as a CRA in Clinical Operations processes, Clinical Development, Regulatory, TMF and Data Management. Skilled in data audit/review Study start up, Study conduct, Vendor management, and Site monitoring activities extensive knowledge of GCP-ICH, GLP, GMP guidelines familiar with Ex...
Tags for this Online Resume: Protocol, Assessments, Audit, Clinical Research, Documentation, Pediatrics, Research, Clinical Management, Distribution, oncology, phase, trial, clinical, protocol, pharmaceutical, gcp, ich
Principal - 20 Years of Experience - Near 32765
QUALIFICATIONS SUMMARY Enthusiastic achiever with exceptional knowledge in Occupational Safety, Industrial Hygiene and Environmental compliance with over 20 years of experience. Experienced professional with a successful career in safety, environmental and industrial hygiene policy development, implementation and administration Familiar with federal, state and local regulations and policies regarding worker and industrial h...
Tags for this Online Resume: EHS, Safety Manager, Environmental, Health and Safety, HHS, Environmental Health, Global EHS, Safety Director, EHS VP, Occupational Health, Iris
Construction Driller
Summary I have 31 years of domestic and international drilling expertise as a Drilling Manager, Engineering Manager, Superintendent, and Engineer for projects in deep water & shelf Gulf of Mexico, Bay of Campeche, the East Coast of Trinidad, onshore China, Louisiana, Mississippi, Alabama, and Texas. I recently added technical, insurance, securities, and retail sales to my skill set. I am an innovative problem solver and hav...
Tags for this Online Resume: Management, Onshore, Project Management, Consulting, Cost Control, Harvester, Procurement, Engineering, Triton, A SERIES
Certified Clinical Research Coordinator - 13 Years of Experience - Near 34202
Seasoned Certified Clinical Research Coordinator with 13 years' experience as a CRC, including experience in marketing, advertising, and regulatory document completion and submission. Completed my duties with great attention to detail, compassion, professionalism, confidentiality, and care. Seeking a position in healthcare/clinical research/pharmaceutical industry that will allow me to continue to exercise these skills and ...
Tags for this Online Resume: Clinical Research, Research, Good Clinical Practices, Protocol, Advertising, Documentation, Marketing Management, NPI, Training, Accounts Payable, clinical, trial, phase, gcp, protocol, pharmaceutical, GCP, IRB, CRF, ich, AE, SAE, SUSAR, Inclusion and Exclusion Criteria, ECG, Biological, PK, PG, Substudy, ICF, EDC, Rater, concomitant medications, IP, IP accountability, regulatory documents, master file
Clinical Regional Monitoring - 17 Years of Experience - Near 46321
SUMMARY OF CLINICAL EXPERIENCE Eleven years' experience as a CRA which includes 2 years as a Lead CRA in clinical trial monitoring, including study start up, study initiation through closeout, as well experience in International, and Domestic studies. Provide on-site clinical trial monitoring and full site management at investigational sites in the conduct of Phase II-IV clinical trials. Recruited and trained CRA (s), inves...
Tags for this Online Resume: Data Management, Gastroenterology, Management, Patient Education, Pharmaceutical Industry, Start up, Clinical Research, Research
Clinical Regional Monitoring - 20 Years of Experience - Near 18929
Seeking an opportunity with a Pharmaceutical, Biotechnology company or CRO as a Senior Lead Clinical Research Associate, Lead CRA, CRA Manager/Trainer (Mentor) and/or CRO Oversight Monitor to employ my 27 years of clinical research monitoring, management skills and CRA mentoring as well as19 years of Respiratory/Pulmonary and Cardiopulmonary critical care clinical medicine. Clinical Research Experience: Projects/Therapeutic...
Tags for this Online Resume: Pharmaceutical, Clinical Research, Research, Rheumatology, Biomedical Industry, Pharmaceutical Industry, Cardiology, Critical Care - Neurology, Critical Care - Respiratory, Neurology, oncology, clinical, phase, gcp, protocol, trial, ich
Manager
Summary of Qualifications Highly accomplished biotechnologist and project manager with extensive knowledge of federal regulatory procedures, policies and protocol. Proven ability to apply new technologies to enhance research project outcomes. Respected team leader with expertise in data analysis, experimental design, lab management and prepary research reports and regulatory documentation. Solid track record of collaboratio...
Tags for this Online Resume: Instrumentation, Procurement, Biomedical Industry, Gastrointestinal, Laboratory Instrumentation, Research, Technical Writing, Science, Data Analysis, PeopleSoft, manager, management
