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Online Resumes with "Electronic submission"
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
Clinical Pharmacovigilance/Drug Safety
SUMMARY * Medical degree with over 25 year experience in clinical and drug safety surveillance setting within the pharmaceutical and Biopharmaceutical industry (Example: Amgen, Alza Corporation, Idec, Biogen Idec, Elan, Genentech, Roche, Sharing AG, Wyeth, Élan Pharmaceuticals, Actelion Pharmaceuticals) * Advance knowledge of US and international Safety regulations and Safety assessment of Marketed and Investigational drugs...
Tags for this Online Resume: Training, Data Entry, Coding, Policies and Procedures, Clinical Research, Data Management, Immunology, Management, Oncology, Query
Developer - 7 Years of Experience
PROFESSIONAL SUMMARY * Over 9 years of Clinical SAS programming experience in a Pharmaceutical industry involving different Phases (I, II & III) of clinical trials. * Experienced in working closely with statisticians to provide SAS programming in analyzing clinical trials data and generating Statistical Analysis Files, Tables, Listings, Summaries and Graphs/Figures (TLFs) for the Integrated Summary of Safety (ISS) and Integ...
Tags for this Online Resume: Microsoft Windows, SAS, Structured Query Language, Unix, Microsoft Windows 7, Windows 7, PDF, Proc, Extensible Markup Language (XML), Microsoft Excel
Medical Office Manager - 20 Years of Experience - Near 75115
Professional Summary Led within the Healthcare Industry specifically as it relates to electronic and medical claims billing. Over past three years, directly responsible for maintaining data records and submitting $100M in electronic claims monthly Analysis with extensive experience in Electronic submission. Proficiencies include claims, customer service and reporting. Core Qualifications Electronic Billing Experience * Prof...
Tags for this Online Resume: Cognos, Payerpath, analytical, Works well with all levels, Excel, Systems Analyst, ANSI, Ansi (Am Natl Stds Inst), Billing, Documentation
Clinical Regulatory Affairs - 5 Years of Experience
Profile Regulatory Affairs Specialist with more than five years of experience in the pharmaceutical and biotechnology industries, implementing global regulatory filing strategies. Education in biotechnical engineering with deep knowledge and practical skills in managing the submission process from start to end, monitoring and tracking information, communicating with colleagues, managers and subject experts for efficiency an...
Tags for this Online Resume: Manufacturing, Packaging, Pharmaceutical, Regulatory Affairs, Biotechnical, Filing, Management, Medical, Medical Devices, Microsoft Office
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
General - 13 Years of Experience - Near 10701
Summary of Qualifications Enthusiastic, self-starter with the ability to present products/ideas persuasively and build rapport. Flexible, multi-tasker with a strong work ethic and ethics and character of the highest caliber. Creative, attentive to the completion of precise tasks and projects. Enjoys taking initiative beyond stated job and is sensitive to needs of others. Qualified professional providing expertise in the lab...
Tags for this Online Resume: Technical Writer, Quality Assurance, Regulatory Affairs, Research, Compliance, Manufacturing, Quality, Quality Control, Documentation, Reliability, Research and Development, Document Control, HIV
Project Manager - 17 Years of Experience - Near 27613
621 Leader of 5 Federal and 11 contractor technical project managers operating as the single point of contact for all Information technology planning, design, development, and deployment of infrastructure and application support for the business in the a $500M Oracle Seibel CRM modernization project of the entire US Citizenship and Immigration Service benefits program from a paper system to electronic submission and approva...
Tags for this Online Resume: Agile Methodologies, Agile methodology, Artificial Intelligence, Consulting, Financial, Framework, HR, Human Resources, Management, PeopleSoft
Biostatatician
Accomplishments * Complete more than 100 studies including phase I to phase IV. * In charge of 20 phase I and 4 phase III study NDA submission tasks to ensure high quality deliverables that comply regulatory electronic submission guidance * Preparation of statistical analysis plans including mock up tables * Application of statistical section of clinical trial reports * Review of protocols/case report forms/statistical anal...
Tags for this Online Resume: SAS, Statistical Analysis, Documentation, Management, Pharmaceutical, Quality, Quality Assurance, Quality Control, Batch Processing, Biomedical Industry
SR Director has
Accomplishments included: * Program Manager responsible for day to day leadership, management, and 1.3 million dollar annual budget to make sure TTI meets the needs of the FDA project manager and the business customer for Electronic Submission Portal for the Center for Drug Evaluation and Research for Operations and Maintenance and Development Enhancements. * Responsible for Business Development Management and writing gover...
Tags for this Online Resume: Accounting, Agile Methodologies, Agile methodology, Applications, Appraisals, Assessments, Audit, Budgeting, Business Development, CIO, agile, it jobs, software
Clinical SAS Programming
SUMMARY: Over Nine years of experience in SAS programming with good knowledge of advanced statistical methodologies applied in Pharmaceutical and Biotech industries. Expertise in analyzing and reporting various phases (Phase I-IV) Of Clinical Trials using tools like Base SAS, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/MACRO, SAS/ACCESS and SAS/ODSin UNIX and Windows environment. Developing Debugging and validating the project-specif...
Tags for this Online Resume: Programming, Support, Microsoft Windows, SAS, SAS/STAT, Data Management, Management, HyperText Markup Language, Oncology, Macro (Predefined Code)
System Administrator
Ideal Companies: FDA
Tags for this Online Resume: SharePoint, Sharepoint Technologies, Help Desk, Ssl, Statistics, Support, Troubleshooting, AS2, Axway, Citrix
