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Online Resumes with "Regulatory Submission"
Architect - 11 Years of Experience - Near 08817
PROFESSIONAL SUMMARY * Experienced Selenium Automation Testing. * Good experience in Web UI automation testing with Selenium Web Driver, Java, Junit, TestNG frame works. * Proven experience in using Java and CSharp for Automation * Experienced in setup Project Setup in Eclipse * Experienced in suggest and creating new Framework from scratch or can adopt existing frameworks as well. * Experienced in working on Data Driven fr...
Tags for this Online Resume: Documentum, Documentum (Wkflow Sw), Integrate, Test, Test Plan, Java Programming Language, Javascript, Selenium, Sharepoint Technologies, Test Script
Director
QUALIFICATIONS: Over twenty years drug development experience ranging from pre-clinical pharmacology / toxicology to managing and directing clinical and cross functional teams in the conduct and execution of global, clinical trials. Experience includes coordinating and planning for budgeting, resourcing, drug supply, site and sponsor audits, and global regulatory submissions. Management experience includes management of in-...
Tags for this Online Resume: Data Management, Management, Nephrology, Clinical Research, Clinical Study Reports, Drafting, Oncology, Project Management, Project Manager, Protocol
Clinical Research - 10 Years of Experience - Near 19107
To pursue a challenging career in clinical research
Tags for this Online Resume: Clinical Project Manager (Radiology/ Medical Imaging), protocol design in oncology, Evaluation of therapeutic drugs, regulatory submissions, imaging biomarker , statistical principles and applications, speak Japanese, Hindi, Nepali, and Tagalog, planning and execution of sponsored clinical trial study
Marketing - Near 94401
Summary of Qualifications Seeking a position in Medical Affairs/Medical Writing/Regulatory Affairs/Marketing/Publications: * Pharmaceutical, Medical Device, Biotech and High Tech industry management experience and training * Expertise in translating complex technical, scientific and medical information into internal and global customer communications strong client communication skills Experienced with literature reviews, se...
Tags for this Online Resume: Advertising, Management, Project Management, Statistical Analysis, Telemarketing, Billing, Budgeting, Certificate Authority, CMM (Capability Maturity Model), Coding
Executive Assistant - 15 Years of Experience - Near 95132
Skills Summary Soft Skills *Marketing Sales * Front Office Operations * Culturally Diverse *Report Generation * Scheduling/Calendaring * Work Independently *General Office Skills * Administrative Training * Professional Demeanor *Accounting/Bookkeeping * FDA/Regulatory Submissions * Innovative/Creative techniques * Customer Service * Purchase Requisitions (SAP) * micro-mange calendars Word Processing Skills * MS Word *SAP *...
Tags for this Online Resume: Accounting, Certificate Authority, Customer Service, Front Office, Generate Reports, Lotus, Lotus Notes, Marketing Management, Microsoft, Microsoft Access
Clinical Research
AREAS OF EXPERTISE * Clinical Trial Design * Biologics * Study Management * Medical Devices * Scientific Research * Regulatory Submissions * Program Development * KOL Relationships * Scientific Strategy * Oncology * Regulatory Strategy * Cardiovascular * Investigator Recruitment * Gastrointestinal * International Clinical Trials * Regenerative Medicine * Data Analysis * Surgery
Tags for this Online Resume: Clinical Research, Research, Pathway, Protocol, Regulatory Affairs, Infrastructure, Pharmaceutical, Publications, Selenium, Venture Capital, oncology, phase, clinical, gcp, protocol, trial, pharmaceutical, ich
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 Pharmacovigilance/Drug Safety - 10 Years of Experience - Near 19440
Summary Clinical Scientist/Clinical Data Analyst/Clinical Data Management/Project Coordinator/GLP auditor/Research Biologist with over 15 years experience in the pharmaceutical industry. Authored/QC review of protocols, protocol amendments, protocol clarification letters, informed consent forms, risk language, periodic safety reports (PSUR, DSUR, QSR), investigator brochures, medical monitoring plans, clinical SAE narrative...
Tags for this Online Resume: Protocol, Oncology, Audit, Monitoring, Critical Care - Neurology, ICH, Neurology, Quality Assurance, Test, Data Quality
Analysis of patient data through bedside care and pharmaceutical research for 35 years of exemplary work and experience
Objective * RN with 11 years of critical care experience with broad therapeutic clinical experience, expertise in development of processes for patient care, implementation and global training and project oversight. * Sixteen years of clinical research experience, which includes nine years in Drug Safety/Pharmacovigilance experience analyzing subject data. * Quality focused Data Management Associate Director of Clinical List...
Tags for this Online Resume: Business Development, Database, Development Activities, Infrastructure, Gastrointestinal, Intensive Care, Oracle, Critical Care, clinical, research, clinical trials, cro, pharmaceutical, Clinical
Clinical Research - 5 Years of Experience - Near 19128
SUMMARY * Project coordination, document management and coordination experience in a clinical health environment in pharmaceutical industry. Worked for Spark Therapeutics, Baxter, Execupharm, United BioSource (an Express script company) and Liquent (a Parexel Company) * 3 + years of experience in Regulatory Affairs supporting the compilation of regulatory submission and assisting with the publication those submissions using...
Tags for this Online Resume: Documentation, Microsoft Excel, Microsoft Office, Microsoft Outlook, CVS, Distribution, Document Management, Documentum, Documentum (Wkflow Sw), Financial
Chemist - 20 Years of Experience - Near 02467
PROFESSIONAL SUMMARY * A proven leader with a track record of accomplishments with more than fifteen years pharmaceutical industry experience in leading analytical development activities for small molecule drug development * Hands-on experience in analytical project management in drug development and regulatory submissions hands- on experience in analytical method development/validation/transfer in GMP environments expertis...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Quantify, Analytical Chemistry, Chemistry, Research, Research and Development, Regulatory Affairs, Applications, CMOS, Development Activities
Technical Writer - 20 Years of Experience - Near 03031
Summary Senior-level technical writer, trainer, and marketing communications expert, highly skilled in communicating specialized information to a non-specialized audience: * Superior writing and presentation ability in several media * Ability to grasp new subjects quickly * Extensive background knowledge in a variety of areas, especially science, technology, healthcare, and communications * Proven ability to produce documen...
Tags for this Online Resume: Communications, Documentation, Management, User Documentation, Automation, Publications, Internal Auditor, ISO, Security, Technical Documentation
