With 14 years in remote SAS development and Statistical Programming, I have gained invaluable expertise leading and contributing to summarizations of clinical trial results for pharmaceutical and biotech firms. I have been a “go to” SAS resource for Amgen, Cephalon, BD Medical Systems, Astra-Zeneca, Boehringer-Ingelheim, Smith-Kline & Beecham and Miami/Dade Water and Sewer Administration (WASA). I have successfully led mu...
Manage & direct the programming team towards NDA submission.
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
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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)
SUMMARY: To apply my knowledge of FDA Good Clinical Practice guidelines/ICH guidelines, extensive site/field Clinical Director, Site Lead Study Management, in addition to my experience with various therapeutic areas of medicine, to a position as a Clinical Research Associate. AREAS OF EXPERTISE * Management * Interview candidates and either make a selection decision or recommend individuals for hire. * Able to manage multip...
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Clinical Research, Research, Accounting, Acquired Immune Deficiency Syndrome (AIDS), Advertising, Amazon Elastic MapReduce, Audit, Basic First Aid, BLS, Budgeting
Summary of Qualifications Seeking a position in Medical Affairs/Medical Writing/Regulatory Affairs/Marketing/Publications: * Pharmaceutical, Medical Device, Biotech and High Tech industry management experience and training * Expertise in translating complex technical, scientific and medical information into internal and global customer communications strong client communication skills Experienced with literature reviews, se...
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Advertising, Management, Project Management, Statistical Analysis, Telemarketing, Billing, Budgeting, Certificate Authority, CMM (Capability Maturity Model), Coding
Experienced with IND/NDA submissions, and knowledgeable in regulatory guidelines (ICH), 21 CFR Part11 and Good Clinical Practice (GCP). * Highly experienced in clinical protocol development, experimental design, sample-size and power calculation, randomization, and study analysis planning (SAP). * Proficient in SAS/Base, SAS/Stat, SAS/Graph, SAS/Macro and SAS/ODS. * Skillful in data validation data manipulation, graph, tabl...
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Health Care Industry, clinical, protocol, sas, pharmaceutical, sap, ich, gcp, trial, phase, oncology
SUMMARY * B.S. Biochemistry + M.B.A. Pharmaceutical Management with over 17 years of pharmaceutical industry experience * 12 Years of Parenteral Manufacturing experience. Member of PDA. Attended Courses at University Tennessee * 13 years of production experience in an FDA regulated environment such as Biopharma, OTC, medical devices in clinical, commercial drugs, consumer products, and nutraceuticals. * 11 years of producti...
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Forecasting, Medical, Project Management, Project Manager, Scheduling, 5S, Engineering, Kaizen, Outsourcing, SAP, production, manufacturing, reliability, "project management", Clinical drug supply, Packaging and labeling, GMP andGCP, SOP, 21CFR11
SUMMARY OF QUALIFICATIONS Quality Systems - Quality Control /Quality Assurance Management of Analytical Laboratories/Quality Audits/Scientific Technical Services Liaison Highly motivated, key contributor in Quality Management and cGMP compliance with more than twenty five years of demonstrated growth and success in scientific applications with Contract Manufacturing Organizations in Quality, R&D and manufacturing. Recognize...
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Analytical Chemistry, Chemistry, Manufacturing, Research and Development, Commercial Production, Compliance, Packaging, Pharmaceutical, Documentation, Quality, validation, Audits
Experienced with CDISC SDTM (IG 3.1.2 and 3.1.3) and ADaM (IG 1.0) standards. * Created safety, and efficacy SDTM and ADaM datasets, summary tables, listings and graphs (TLFs). * Proficient at using SAS data step and procedures. * Experienced in generating Integrated Summaries of Safety and Efficacy (ISS, ISE). * Validated Analysis datasets and TLFs using parallel programming and other validation techniques. * Created new m...
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Operating Systems, Pharmaceutical, Pharmaceutical Industry, Proc, Programming, Protocol, Quality, Quality Assurance, Relational Database, SAP, java, it jobs, javascript
