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Online Resumes with "ICH"

Chemical Equipment Operator - 8 Years of Experience

Tags for this Online Resume: ISO, Pharmaceutical, Quality Assurance, Test, SAP, Spectrophotometer, ICH, ISO 9001

Clinical Research - 7 Years of Experience - Near 40009

Tags for this Online Resume: Source data verification, ICH GCP, Site monitoring, CRF review, Communication with site, Ethics committee and sponsor, compliance to protocol

Biostatatician

SUMMARY Accomplished and result-driven Quality and Regulatory Affairs professional with 15 years of experience in the Medical device and Drug industry, along with over 17 years of leadership, project management and process improvement (Six Sigma or lean manufacturing). ACCOMPLISHMENTS * Developed, implemented and managed quality systems in GMP and GCP settings based on FDA, ISO, MDD, CMDR, ICH, and IEC regulations and guida...

Tags for this Online Resume: Training, Cardiovascular, CT, Documentation, Imaging, Magnetic Resonance Imaging (MRI), Management, Medical

Clinical Pharmacovigilance/Drug Safety - 2 Years of Experience - Near 27713

Tags for this Online Resume: FDAguidelines, Medical writer, ICH GCP, Essential documents, Regulatory guidelines, E3 guidelines, Investigator brochure, ICF

Biostatatician - 5 Years of Experience

Profile A multilingual result-driven biostatistician and SAS programmer with more than 15 years of professional experience. Broad experience of data manipulation in medical research, pharmaceutical research, clinical trials. Thorough knowledge of drug development processes at CROs, ICH guideline and GCP certificate. Proficient at SAS programming with 8 years of experience in data analysis, statistical modeling, data prepara...

Tags for this Online Resume: Active Directory Application Mode (ADAM), Data Analysis, Medical, Statistical Analysis, Programming, Protocol, Research, SAP

Physician - 19 Years of Experience

Transitioning from direct patient care to a research-based career. Looking for Clinical research associate (CRA) openings.

Tags for this Online Resume: Medically trained., Clinical Research, SOP, GCP, ICH

Chemist - 15 Years of Experience - Near 07747

SUMMARY OF FUNCTIONAL EXPERIENCE AT AKORN: Hands-on experience with pharmaceutical analysis using HPLC, GC/HS, Spectroscopy, physical and wet chemistry. Familiarity with Analytical Chromatography software Backman Peak-Pro, Perkin Elmer TotalChrom and recently implemented Thermo Fisher Chromeleon. Trackwise software for OOS, OOT and deviation investigation. iStability software for stability monitoring and trending. * Quality...

Tags for this Online Resume: Pharmaceutical, Pharmaceutical Industry, Quality Control Chemistry, Quality Control Chemistry, Quality Control, Accredited Pension Representative, Audit, QC Manager

Medical Office Manager - 1 Years of Experience - Near 02120

Seeking a position to utilize my skills and abilities in the corporate sector that offers professional growth which is being resourceful, innovative and flexible. Knowledge of ICH guidelines and safety reporting requirements, good manufacturing practices (GMP), good laboratory practice (GLP) and good clinical practices (GCP). Understanding of FDA regulations and knowledge of IND, NDA, BLA, Drug Master File (DMF), 510(k) and...

Tags for this Online Resume: Boston, GLP, GCP, FDA Regulations, Medical Device

Documentation

Seek challenging opportunity. My work experience and qualifications are diverse and include 10 years contracting to the Pharmaceutical Industry. Recently, I’ve earned applicable Clinical Trial subject matter certificates e.g., Kriger Research Group International (KRGI): Clinical Research Professional ICH/GCP – Certificate 9/2009; KRGI: Medical Terminology Program – Diploma 1/2010; Allied Schools: Pharmacy Technician Progra...

Tags for this Online Resume: Documentation

Clinical Research

Experienced Clinical Research Associate seeking a challenging and rewarding Clinical Research Associate (CRA) position that will utilize my clinical site monitoring and general management skills and experience to coordinate, monitor and manage all aspects of clinical trials in accordance with the ICH-GCP guidelines, FDA regulations, standard operating procedures and study protocol.

Clinical Research - 1 Years of Experience - Near 27106

I am actively seeking an entry-level position as a scientist, to enhance my professional growth by providing challenging career while utilizing my existing knowledge and skills.

Tags for this Online Resume: Adobe, Adobe Photoshop, Compliance, Focus, Gateway, Good Clinical Practices, ICH, Imaging

Clinical Research

SUMMARY: * POST-MARKETING REPORTING: Vast clinical experience in reporting post-marketing events in the pharmaceutical industry. * CDM: Acquaintance on clinical data management, pre-clinical and clinical trials (Phase I, II, III and IV) * CLINICAL WRITING & DOCUMENTATION: Create clinical project documents according to the protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard...

Tags for this Online Resume: Ipc, Planning, Protocol, Research, Reuters, Business Planning, Coding, Documentation, Immunology, Information Technology