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Online Resumes with "cmc"
Quality Assurance Director - 4 Years of Experience - Near 08736
Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...
Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate
Microbiologist - 20 Years of Experience - Near 45066
Summary of Experience William H, Fleming, III, PhD has thirty five plus years in the plasma, biopharmaceutical, medical device, contract manufacturing and hospital based clinical industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished plasma derived drug products, medical devices, small molecule sustained release microsphere based drug products, biological prod...
Tags for this Online Resume: Regulatory Compliance, Regulatory Affairs, Regulatory Compliance Auditing, Analytical Chemistry, Method Validation, Process Validation, Microbiology, Standard Operating Procedures, CMC BLA 510K, Policies and Procedures
Clinical Research - 10 Years of Experience - Near 18901
Summary: * Several years of clinical experience in the industry with excellent knowledge of drug development in different therapeutic areas including oncology, immunology, vaccines, metabolism and biosimilars. Solid clinical practice experience. * Many years of Drug Safety, pharmacovigilance, risk management and epidemiology experience * Experience interfacing with health authorities (worldwide), institutional review boards...
Tags for this Online Resume: Oncology, Protocol, Regulatory Affairs, Risk Assessment, Management, Risk Management, Risk Management Activities, Complaints, Documentation, Hematology, Medical Affairs, Clinical Development
Clinical Research - 20 Years of Experience - Near 60202
QUALIFICATIONS * Internist with 20+ years experience working in the the pharmaceutical industry including small, medium and large pharma, CRO and biotech in the USA, Canada, LatinAmerica, and Europe (including Eastern Europe), and Russia. * Board Certificatioon in Internal Medicine and training in Critical Care Medicine. Clinical practice experience in Hospitals, Emergency and Critical Care settings. * Extensive experience ...
Tags for this Online Resume: Project Leader, Executive Medical Director/VP, Protocol, Cancer, COPD, Critical Care - Respiratory, OTC, Clinical Programs, Research and Development, CardioVascular, Pain & Inflammation
Clinical Regulatory Affairs - 4 Years of Experience - Near 02494
SUMMARY * Current graduate student working on second master's degree in Regulatory Affairs for acquiring general insights of regulatory profession and in-depth practical knowledge of regulatory compliance, including CMC (Chemistry, Manufacturing, and Controls) and quality system practices. * Extensive background in the biopharmaceutical industry and 3-year experience in upstream bench-scale cell culture process development ...
Tags for this Online Resume: Biopharmaceutical, Biotechnology, ICH, Regulatory Affairs, Manufacturing, Medical Devices, Regulatory Compliance, quality assurance, FDA, EU, Pharmaceutical, GMP
Clinical Quality Assurance
SUMMARY OF QUALIFICAITONS * Global and domestic cGxP operation, quality and packaging experience in medical/precision and diagnostic devices, pharmaceuticals and biomedical industries * Managed Chemistry and Manufacturing Controls: including API sourcing, vender/raw material qualification, formulation, product/process development, scale-up, clinical supplies, technology transfer and validation * Wrote and compiled CMC porti...
Tags for this Online Resume: Cancer, Consumer Products, Engineering, OTC, Process Engineering, Product Development, Risk Analysis, Commercial Production, Team Lead, API
Computer Programmer - 10 Years of Experience - Near 30328
10+ years of professional experience in various sectors like Asset management Private Equity Banking Retail and Logistics. Have 5+ years of client site experience in Edinburgh UK for Standard life Investments and Ameriprise Auto and Home USA. * Extensive experience in developing and implementing projects using Microsoft Business intelligence 2005/2008/2012 (Microsoft SQL Server Integration Services (SSIS) SQL server Analysi...
Tags for this Online Resume: Microsoft SQL Server, SQL Server Integration Services, SQL Server Reporting Services, SSIS, Structured Query Language, T-SQL, Crystal Reports, Microsoft Excel, Microsoft Visual Studio, Microsoft Windows
Clinical Pharmacovigilance/Drug Safety
A strategic new product development leader with over twenty years of accomplishments in a cross functional role spanning multiple therapeutic areas in small and multinational companies with continued success in innovator specialty and drug-device product formulation CMC strategic portfolio/program management/planning IP mission critical decision making phase appropriate product development NIH grant writing regulatory clini...
Tags for this Online Resume: Business Development, Licensing, Project Leader, Project Management, Management, Pharmaceutical, Diagnostics, Leadership, Planning, Program Management
Quality and Regulatory Compliance
SUMMARY Expert Quality and Regulatory Compliance Professional, experienced in global processes and systems that assure appropriate cGMP/Regulatory compliance levels are maintained at all times across geographical territories. Excellent understanding of the ever-changing regulatory environments and well-versed in requirements and mitigating risks. Drives resolution. Provides leadership, guidance and solutions to complex qual...
Tags for this Online Resume: CMOS, Health Care Industry, Integrate, Training, Documentation, Intensive Care, Document Review, Filing, Planning, Services
Scientist - 15 Years of Experience - Near 30045
PROFESSIONAL SUMMARY * Result oriented, Creative, Passionate, highly focused, experienced Pharmaceutical R&D Scientific Lead with good ethics, possessing over 15 years of experience in Formulation design, Process Development, Optimization and Scale up of various Pharmaceutical Dosage Forms, Solid Orals (IR and ER Tablets and Capsules), Liquid Orals (Solutions, Syrups and IR / ER Oral suspensions), and Parenteral formulation...
Tags for this Online Resume: Product Development, Filing, Pharmaceuticals (Generics), Formulation Research, Management, Budgetary, Process development, Oral solid dosage forms, Manufacturing, ANDAs
Medical & Clinical Laboratory Technologist - 20 Years of Experience - Near 07076
An accomplished scientist with proven track record in successfully managing complex scientific projects. Ability to work independently as well as to collaborate across functional areas. A positive inspirational personality combined the ability to pay attention to details. A hard working ethic and consistent delivery under strict timeline. A key contributor to many priority projects and publications.
Tags for this Online Resume: Clinical Data Management, Medical Writer, Oncology, Clinical Research Associate (CRA), Regulatory, Pharmaceutical Research, Clinical Coordinator, CMC, New Jersey, Clinical Trial Management, Medical Affair, SAS and Oracle Clinic
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
