CV, Curriculum Vitae and Online Resumes Search

---

Online Resumes with "IND NDA"

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

Clinical In-house Monitoring - 6 Years of Experience - Near 07621

SUMMARY OF QUALIFICATIONS Pharmaceutical professional with 5+ years of clinical research experience in management and monitoring. Seeking new and exciting opportunities in new therapeutic areas to expand my expertise. Known for building strong relationships with clients and partnering with management teams to ensure quality services, compliance and efficiency. Manage Clinical Research, third party vendors, and clinical inst...

Tags for this Online Resume: Fraud, ICD-9, Insurance, Medical, Query, Management, Good Clinical Practices, ICH, Documentation, Clinical Research

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

Clinical Pharmacovigilance/Drug Safety

SUMMARY * Health care professional with extensive years of experience with Pharmaceutical/Medical device industries as Medical coding and Pharmacovigilance professional in the processing and medical review/evaluation of reports related to investigational and marketed products in the following therapeutic areas: Oncology, Neurosciences, Cardiovascular, Pain/Inflammation, Rheumatology and Diagnostic products. * Responsible fo...

Tags for this Online Resume: Management, Process Improvement, Coding, Regulatory Reporting, Audit, Cardiology, Compliance, Metrics, Oncology, Data Entry

Chemist - 13 Years of Experience - Near 07728

To obtain a challenging position in pharmaceutical industry involved in drug discovery and quality control that takes advantage of my experience in medicinal chemistry, organic synthesis and analytical laboratory skills. Willing to make an impact for the success and growth of a cutting edge company by utilizing my skills and experience. Professional Summary: * Experienced in medicinal chemistry, organic synthesis and qualit...

Tags for this Online Resume: Chemistry, Research, Sar

CEO of Quality/Regulatory Affairs- 19 Years of Experience - New York

SUMMARY Senior Executive with combined technical, regulatory strategy, project management and business experience to build businesses and relationships to deliver new products to market. Over 20 years of experience in medical device, pharmaceutical, biologics, and diagnostic development, including In-Vitro Diagnostic, with market leaders such as Johnson & Johnson, Watson Pharmaceuticals and Mela Sciences. Led worldwide regu...

Tags for this Online Resume: Management, Manufacturing, Product Development, Risk Management, Process Engineering, Engineering, Quality, Quality Assurance, Quality Control, Regulatory, Strategy, Clinical Development, Pharmaceutical, Medical Device, Green Belt, PnL

Biostatatician - 18 Years of Experience - Near 07059

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...

Tags for this Online Resume: Health Care Industry, clinical, protocol, sas, pharmaceutical, sap, ich, gcp, trial, phase, oncology

Clinical Regional Monitoring - 20 Years of Experience - Near 18929

Seeking an opportunity with a Pharmaceutical, Biotechnology company or CRO as a Senior Lead Clinical Research Associate, Lead CRA, CRA Manager/Trainer (Mentor) and/or CRO Oversight Monitor to employ my 27 years of clinical research monitoring, management skills and CRA mentoring as well as19 years of Respiratory/Pulmonary and Cardiopulmonary critical care clinical medicine. Clinical Research Experience: Projects/Therapeutic...

Tags for this Online Resume: Pharmaceutical, Clinical Research, Research, Rheumatology, Biomedical Industry, Pharmaceutical Industry, Cardiology, Critical Care - Neurology, Critical Care - Respiratory, Neurology, oncology, clinical, phase, gcp, protocol, trial, ich

Production Manager - 157Years of Experience - Near 08723

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...

Tags for this Online Resume: 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

Clinical Regulatory Affairs - 2 Years of Experience - Near 02215

PROFESSIONAL SUMMARY: A Regulatory Project Manager with 2+ years of managing IND/NDA/BLA review processes and 1+ years of cGMPs experience in pharmaceutical industry. Deadline-driven and highly reliable professional, successfully managing over 300 applicants' submissions in IND, NDA, BLA, and BSE as well as participating in 4 cGMPs sponsors' inspections (Japan and Taiwan) and 1 FDA inspection at manufacturing plants. Great ...

Tags for this Online Resume: Compliance, Pharmaceutical, Project Management, Regulatory affairs, CMC, NDA, IND, BLA, cGMP, GCP, ICH

Statistical Programmer - 5 years Experience - US

Summary * Certified Base Programmer for SAS 9 with 5+ years of biostatistical programming experience in CRO, hospitals, pharmaceutical, and healthcare industries. * Involved in drug development process with experience in analyzing, reporting, and reviewing pre-clinical/clinical trial data. * Good understanding of FDA submission (IND, NDA) process, clinical protocols, CRFs, CDISC (SDTM, ADaM), 21 CFR Part 11, GCP, and IRB gu...

Tags for this Online Resume: SAS, Proc, Programming, Statistical Analysis, SAP, Research, Statistics, Structured Query Language, Management, Test