CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "FDA Submissions"

Senior Level Biotech & Pharmaceutical Experience

To use my strong Research and Development, QC and QA background in a Qualilty Assurance or Regulatory environment.

Tags for this Online Resume: Assay development, FDA submission

Clinical Research - 8 Years of Experience - Near 60169

Professional Summary A certified professional Clinical Research with 4 years of experience in Clinical Research coordination and a year experience as Clinical Study Associate. Expertise in QC of documents, remote Monitoring and supporting the management by handling the tasks of multiple clinical research studies managing eTMF's & designing Clinical Portfolio's from Sponsor end. Expert in liaising between different departmen...

Tags for this Online Resume: Document Management, Monitoring - Remote and onsite, Clinical Research coordinator, Device trials, clinical Research, Project Management, QC and QA, Pharmacovigilance, Ethics and compliance, regulatory, Clinical study Associate, Multiple therapeutic areas experience, Phase 1-4 trials, Audits and Inspection readiness, Multiple software and application experience - Veeva VAULT , Impact , Quest , Sentinel,Tesla, EDC experience- RAVE Medidata, IRT system experience Clinpace , Endpoint

Biomedical Engineer - 2 Years of Experience - Near 94105

SUMMARY A highly skilled Biomedical engineer familiar with every aspect of medical devices from concept to commercialization. Qualifications include design history file management, SOLIDWORKS associate certified (in progress), 3D printing and prototyping, six-sigma methodology, FMEAs, manufacturing process, FDA submission.

Tags for this Online Resume: Biomedical Industry, Bluetooth, C++ Programming Language, Documentation, Engineering, Management, Manufacturing, Biomedical engineer, Medical devices, Solidworks, Six sigma, FMEAs

Mechanical Engineer - 13 Years of Experience - Near 46037

To seek a position in a work environment that rewards performance while contributing to the growth and success of the organization. To obtain a position that will provide the ability to apply my management/leadership skills, communication and relationship skills, my ability to lead by example while mentoring employees and encourage individual growth, to meet project objectives and deliverables while maintaining a productive...

Tags for this Online Resume: plastic injection molding, Project Manager, Mechanical Engineering, SAP, Validation/Verification Testing, Project Leader, Manufacturing, GD&T, electronic packaging, IQ/OQ/PQ, Michigan, FDA, ERP, Supplier Relationship, RFQ, MS Project, DFMEA & PFMEA, Pro Engineer

Programmer Analyst - 8 Years of Experience - Near 22042

PROFESSIONAL SUMMARY * Over 8 years of experience in Information Technology field with strong emphasis in SAS Application Analyst/ Programmer with 3+ years of hands on experience and professional experience in Clinical Trial projects and also worked as Application Analyst in the CROs, Healthcare and Pharmaceutical industries. * Experience in analyzing and coordinating clinical data, generating detail summary reports and dat...

Tags for this Online Resume: Management, Oracle, Oracle 9i, Information Technology, Process Improvements, Coding, Health Care Industry, HyperText Markup Language, Manufacturing, sql, SAS analyst

Biochemist - 18 Years of Experience - Near 21224

QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...

Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical

Principle / senior programmer / scientist - 20 Years of Experience - Near 98004

Professional Summary: Experienced software development professional with excellent technical, analytical and communication skills demonstrated by successful completion of numerous application software products implemented in medical device development, including cardiac monitoring and resuscitation products, from concept through implementation and final FDA submission and acceptance testing. Articulate and innovative resear...

Tags for this Online Resume: Documentation, User Documentation, VITAL SIGNS, Cardiac Monitoring, Data Analysis, Monitoring, Software, Test, Medical, Medical Devices, algorithm, scientific, FDA, Concept to V&V Testing, Innovative, imaging, ultra sound, signal processing

Project Manager - 15 Years of Experience

Career Highlights Conducted requirements analysis and user feedback sessions (internal users to members of Congress) and provided summary analysis with recommendations for user experience improvements. Produced next generation site with more intuitive user interface. (Canton Group) Managed successful launch of portal for Audi of America (AoA) by leading requirements gathering, prototyping, client feedback, presenting update...

Ideal Companies: Frog Design, Google, uShip

Tags for this Online Resume: Product Development, Test, Test Plans, Management, Medical, Project Management, Protocol, Troubleshooting, Applications, Cascading Style Sheets, agile, software, html, requirements gathering, QA

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

In Between - 5 Years of Experience - Near 500081

Career Summary * SAS Certified Base for SAS9 with more than four years of experience. * Worked on different Phases of clinical trials and I have experience in programming, SDTM, ADAM and reporting in Clinical Research using SAS environments. As a Clinical SAS * Worked on Various Complicated SDTM domains like LB, MO & OE for ophthalmoscopy studies * Understanding of the study Documents and Data (e.g. Study design and objecti...

Tags for this Online Resume: A SERIES, Active Directory Application Mode (ADAM), Base SAS, Cardiology, Clinical Research, Data Management, Documentation, Generate Reports, HyperText Markup Language, Macro (Predefined Code)

Biomedical Engineer

Execution of entrepreneurial strategies with product manager discipline * Complete product lifecycle experience including requirements engineering support and marketing Blending engineering business and clinical resources * Design of edge analytics for IoT enabled services * Service modeling and development relating to personalized health and risk stratification Five successful product releases (multiple FDA submissions) * ...

Tags for this Online Resume: Technical Lead