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Online Resumes with "ICH "
Clinical Research - 20 Years of Experience - Near 07042
Summary: * Expertise towards drug development and FDA, GCP/ ICH regulatory guidelines in the pharmaceutical industry Strong experience in a drug development performing different phases of clinical trials and Supported CTH in managing interactions with relevant line functions including Data Management, Drug Supply Management and Novartis Country Organizations and also performed Monitored pre-study, initiation, interim, close...
Tags for this Online Resume: Clinical Research, Research, Oncology, Query, Cardiovascular, Filing, Management, Database, Database Maintenance, DSS
Chemist
SUMMARY OF QUALIFICATION An accomplished research professional with excellent communication skills who is organized, detail oriented and a team player. Has over 21 years of experience and extensive background that includes leadership role in analytical research in many reputed pharmaceutical organizations. KEY AREA OF EXPERTISE Lead and supervised a team of scientists to execute analytical method development, method validat...
Tags for this Online Resume: DSC, Emerging Markets, High Performance Liquid Chromatography (HPLC), Spectrophotometer, Management, Engineering, Reverse Engineering, Accounting, CFR Part 11, Cost Accounting
Clinical Research - 15 Years of Experience - Near 54901
Summary Seasoned director of clinical operation and project management with over 18 years' experience in local and global CRO and pharmaceutical industry, specializing in phase I, BA/BE start-up operations. Complete and solid understanding of business priorities, genuine team player committed to managing operations and projects efficiently and without flaws, while contributing to revenue producing activities. Serve as a key...
Tags for this Online Resume: Clinical Research, Research, Dermatology, Support, Clinical Management, Documentation, Management, Ophthalmology, Outsourcing, Cardiology
Pharmaceutical Scientist
ver fifteen years of solid experience in pharmaceutical Quality Assurance, Quality Control, Stability, Analytical methods development, Validation, Instrumentation, Lab supervisor and Academic. Accomplished, results-oriented individual with expertise in pharmaceutical area. Extensive hands on experience with HPLC, TLC, GC, TGA, UV/VIS, FTIR, IR, AA, Fluorescence Spectrophotometer and Dissolution. Up-to-date knowledge of cGM...
Ideal Companies: J&J, Celgene, Merck
Tags for this Online Resume: Scientist
Clinical Regional Monitoring - 0 Years of Experience
To obtain a fulltime/permanent Clinical Research Associate position having 10 plus years clinical trial experience as a Clinical Research Associate and laboratory Quality Assurance Auditor excellent organization and communication skills travel expertise superior clinical laboratory experience and knowledge coupled with the desire to manage, mentor and train others.
Tags for this Online Resume: Management, Audit, Hematology, Microbiology, Venipuncture, Banking Industry, Blood Bank, Emergency Medicine, Trauma, Pathology, clinical, gcp, protocol, trial, pharmaceutical, ich, phase
Case Manager
Tags for this Online Resume: Clinical Research, Research, Clarify, Drug Protocol, Good Clinical Practices, ICH, Protocol, Leadership, Query, Documentation
Life Scientist - 20 Years of Experience - Near 76049
Summary * 20 years of professional experience in Biotech-Pharmaceutical Industry, primarily in biologics * Experienced in establishing and monitoring technical and regulatory CMC early and late phase drug development, and life cycle activities * Reviewing and approving CMC documentation including technical and validation reports, batch records analytical methods * Authoring and reviewing of CMC sections for regulatory submi...
Tags for this Online Resume: Budgeting, Business Strategies, Business Strategy, Chemistry, Coaching, Communication Skills, Documentation, Filing, Good Manufacturing Practices, ICH
director travel 11 Years of Experience
i would like to have any good job , im hard worker
Tags for this Online Resume: Tourism, BIS, Travel, GE, ICH, Instant Messaging, Management, Marketing Management
Sr. Clinical Research Associate - 22 years Experience - remote - Austin, TX
A top-performing Senior Clinical Research Associate with extensive experience in clinical research, GCP, ICH, Regulatory, and clinical site management/monitoring. Solid background in critical care nursing for in-depth understanding of medical terminology for records review. Highly skilled in spearheading internal teams through clinical research and document management to ensure accuracy and adherence with study specific str...
Ideal Companies: Pharmaceutical, Biotech, Medical Device, CRO
Tags for this Online Resume: Clinical Research, Management, Protocol, Research, Documentation, Medical, Allergy, Monitoring, Reporting Tools, Cardiology, clinical, trial, gcp, protocol, pharmaceutical, regulatory, medical device, CNS, EDC, contract, remote, CRO
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
Biochemist - 15 Years of Experience - Near 76049
Tags for this Online Resume: Budgeting, Business Strategies, Business Strategy, Chemistry, Coaching, Communication Skills, Documentation, Filing, Good Manufacturing Practices, ICH
Director/Vice President Supply Chain (transformation specialist)
In a nutshell, I have total 24+ years of business acumen with SAP Implementation experience, out of it 18+ years in SAP Supply Chain Management (SCM) implementation. I am expert in Sales and Operational Planning (S&OP) and have implemented SCM-DP, SCM-SNP, SCM-PP/DS, SNC (earlier known as SCM-ICH) and PI in various implementations. Beside it, I have extensive implementation knowledge of ECC 6.00, HANA 1.0, BW and BOBJ tools.
Ideal Companies: Google, Apple, Coke, Pfizer, Nike, Fedex, BD, Hershey
Tags for this Online Resume: Consulting, SNP, Planning, Strategic Planning, SAP, SAP MM module, SAP R/3, APO, Budgeting, Supply Network Planning, Demand Planning, Sales and Operational Planning (S&OP), HANA, Master Data Management, Supply Chain Planning, SAP Production Planning (PP) Module, Advance Planning and Optimizing (APO), Integrated Business Planning (IBP), Supply Network Collaborations (SNC), Block chain, sap leonardo machine learning, C computer language, Note JS language, Supply Chain business expert, SAP ECC
