CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "ICH"

Clinical Research/Pharmacovigilance - 3 Years of Experience - Near 10001

Current MPH Student in Epidemiology at Columbia University, PhD in Biological Sciences, experienced in Clinical Research Development & Management, Pharmacovigilance and Health Information Technology.

Tags for this Online Resume: SAS, Clinical Research, ICH-GCP, FDA/EMEA/MHRA, Drug Safety, Study Design, New York

Cllinical Research Associate

ANDRÉNE (ANDI) JOHNSON, CCRA 1859 Southwood Drive • Lancaster, Texas, 75134 (650) 400-3112 (Cell) (214) 484-6511 (Home) • andisiss@gmail.com January 29, 2010 Dear Sir / Dear Madam: Having contributed to the success of several medical device and pharmaceutical companies by successfully managing and monitoring key clinical research trials, I am seeking the opportunity to join a company such as yours as a ...

Clinical In-house Monitoring - 13 Years of Experience - Near 08068

Skilled in the planning and implementation of clinical research projects in compliance with ICH-GCP, Regulatory Agencies, and company SOP. Study Start up expert. Proficient in Microsoft Office Applications, CTMS, IVRS/IWRS, INFORM, Medidata Rave. Therapeutic areas: Oncology, Cardiology, Neuroscience, Internal Medicine, including Diabetes. Participated in 3 FDA Submissions, FDA Inspection Readiness and TMF reconciliation

Tags for this Online Resume: Princeton, Study startup, In house CRA, CTA, Inform, Medidata Rave

Clinical Research - 10 Years of Experience - Near 11801

Cover Letter Rupal brahmbhatt Respected sir/madam ,, My self Rupal Patel Brahmbhatt. I was working at Synchron Research Services a leading CRO of India. I have been the part of this organization from when it was established, and still I was working with the same organization from 12 years. I have been a part of more than 700 projects as well as clinical studies including USFDA submission projects. I have face the US...

Tags for this Online Resume: MS office, GCP, SOP, CRA, ICF, CRC

Chemist - 20 Years of Experience - Near 07950

Experienced with Master Batch Records, SAP, MES, and Trackwise. * Domestically participated with compliance and supplier audit group and leading Pharma site internal and self-inspections to meet the FDA six Quality Systems. * Managed GMP documentation (policies, guidelines and plans) for audit team activities. * Coached associates for internal and external auditing. * Supported equipment validation by managing equipment val...

Tags for this Online Resume: GMP, ICH , QA, COMPLIANCE, AUDITING, QC, STABILITY, Regulatory Affairs, Data Analysis, Packaging, SAP, Audit, Compliance, Documentation, Good Manufacturing Practices, Documentation, Packaging, Audit, Compliance, Good Manufacturing Practices, SAP, Complaints, High Performance Liquid Chromatography (HPLC)

Clinical Research - 20 Years of Experience - Near 33406

• Clinical Research Consultant with over 28 years of Pharmaceutical/Biotech experience including Phase I – III clinical trial development with direct involvement in multiple FDA/ICH submissions leading to six NDA approvals. • Extensive monitoring domestically and internationally, training and mentoring innumerable CRAs/Monitors in the field which lead to further training responsibilities with Study Teams and Management Te...

Tags for this Online Resume: Florida, Pharmaceutical Research, Monitoring, Management, Team Building

Quality & compliance professional with 24 yrs of experience

With over 24 years of hands on experience in positions of increasing responsibility in Pharmaceutical, Bio and Medical Devices companies. Areas of expertise includes: Quality and compliance (FDA /21 CFR ,809/ICH, GxP’s), CSV (Part 11 and GAMP5) and Serialization (DSCSA), Technical Support (SME for manufacturing and quality areas), Audit in manufacturing and lab areas. Other Quality areas: revision/approval of SOP and Qualif...

Tags for this Online Resume: Quality, Compliance , Validation, Qualification, 21 CFR Part 11, Change control, CSV, 21 CFR 210,211, 809

Clinical Pharmacovigilance/Drug Safety - 5 Years of Experience - Near 39056

Tags for this Online Resume: Argus 7.0.3, Adverse event reporting, MedDRA conventions, Microsoft Office, ICH-Guidelines, Communication skills, Arisg

Clinical Research - 10 Years of Experience

Proactive, solution-driven professional that likes to perform assigned tasks with the best quality possible. With more than 10 years of experience in clinical research starting as Study coordinator, and being on different positions such as CRA, CRS and CPM, enjoying being part of, as well as managing, motivating and training a successful and productive team, through customer focus, team work and good relationships. Experie...

Clinical Quality Assurance - 20 Years of Experience - Near 94403

QA/QC experience working with FDA ICH and Japanese regulations 21 CFR reviewing Writing editing submission documentation SOPs Protocols Reports. Product/Project analytical requirements evaluation budget in-house vs. out-source estimation. Upgrading of R&D laboratories to GLP/GMP level.

Ideal Companies: small start-up company

Tags for this Online Resume: methods transfer validation, phase I, II, III protocols and reports, GMP GLP, Laboratory management, hiring training budgeting, FDA ICH regulations, validation monitoring transfer, medical devices, Consulting, Document Review, Documentation, DSC, High Performance Liquid Chromatography (HPLC)

Quality Engineer - 14 Years of Experience - Near 91016

 Over14 years of in-depth experience in the pharmaceutical industry.  Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes.  Experience in Quality Systems and Manufacturing Operations, Change Control, Process Validation, Documentation, Manufacturing and Maintenance systems utilizing cGMP, industry standards and lean manufacturing approaches...

Tags for this Online Resume: QUALITY, SUPERVISOR, MANUFACTURING, PHARMACEUTICAL , HARD WORKER, RESPONSIBLE, SQL, LIMS, Distribution, Documentation