CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "NDA"

Sales Engineer - 20 Years of Experience

Qualifications: Management, finances, logistics, purchasing, distribution of chemical product, sales. Supervision of electrical and mechanical maintenance team. Chemical process manufacturing. Hands on extrusion, injection molding, cooling system, phenol resins, thermoset, blowing agent, nanotechnology compound. Mould & Design knowledge Technical services on engineering polymers, PPS, Peek, PA, PPI, polyurethanes & colors m...

Tags for this Online Resume: Research, Services, Injection Molding, Sales, Training, ASTM, Chemical Plants, outside sales

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

Chemist - 20 Years of Experience - Near 08816

Areas of expertise: * Formulation & Development * Medical Devices and Design Controls * Rx to OTC Switch, NDA, BLA, Device, and OTC Scale-Up and Commercialization * Project and Program Management * New Product Introductions and Commercial Product Support * Clinical Claim Support and Substantiation

Tags for this Online Resume: Advertising, Audit, Business Development, Diagnostics, Document Management, Documentation, Gastrointestinal, Global Support, Litigation, Management

Executive Assistant - 15 Years of Experience - Near 33578

Senior Executive Assistant provided support for both VP's, and Directors (6) along with senior department leads. Acted as a liaison for top executive support team on all company projects. Coordinated meetings agendas and catering onsite and travelled off-site not limited to special high profile events and event itinerary (South by Southwest-SXSW Festival, Art Basel-Miami etc.). Proactively initiated new approaches executed...

Tags for this Online Resume: Administrative Assistant, Office Administrator, Pharmaceutical, Scheduling, Oracle Parallel Server, Coding, Gastroenterology, HR, Human Resources, Medical, telecommute, sales, administrative assistant, clerical, customer service, administrative, staffing

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

General - 13 Years of Experience - Near 10701

Summary of Qualifications Enthusiastic, self-starter with the ability to present products/ideas persuasively and build rapport. Flexible, multi-tasker with a strong work ethic and ethics and character of the highest caliber. Creative, attentive to the completion of precise tasks and projects. Enjoys taking initiative beyond stated job and is sensitive to needs of others. Qualified professional providing expertise in the lab...

Tags for this Online Resume: Technical Writer, Quality Assurance, Regulatory Affairs, Research, Compliance, Manufacturing, Quality, Quality Control, Documentation, Reliability, Research and Development, Document Control, HIV

Quality Coordinator - 6 Years of Experience - Near 60504

PROFESSIONAL SUMMARY: * Total of 9.5 years of experience in Health Care industry. 6 years' experience in Clinical Data Management. * Worked as a Clinical Data Coordinator in Quintiles Technologies from Feb 2011 to Aug 2014. * Worked as a Clinical Data analyst in PAREXEL International from Aug 2008 to Feb 2011. * Also, I have 3.5 years of experiences in Medical Microbiology field in health care sector I started my career as ...

Tags for this Online Resume: Data Management, Health Care Industry, Management, Microbiology, physical therapist

Project Manager - 19 Years of Experience - Near 85255

SUMMARY: Over 20 years' experience as a senior IT/Business Project Manager with vast experience in Software Development Life Cycle (SDLC), Project Life Cycle (PLC) and Release Management. Major strengths include the ability to successfully and profitably manage numerous small, medium and multi-million dollar turnkey concurrent projects through all project phases from conception through completion within targeted cost, sched...

Tags for this Online Resume: Support, ISO, Leadership, Management, Project Management, Benefits, Billing, Security, System Integration, Technical Requirements, it jobs, c++, agile

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

Project Manager - 20 Years of Experience - Near 85255

SUMMARY: Over 20 years' experience as a senior IT/Business Project Manager with vast experience in Software Development Life Cycle (SDLC), Project Life Cycle (PLC) and Release Management. Major strengths include the ability to successfully and profitably manage numerous small, medium and multi-million dollar turnkey concurrent projects through all project phases from conception through completion within targeted cost, sched...

Tags for this Online Resume: Leadership, Management, Project Management, MS Project, MS Excel, MS PowerPoint, MS Visio, MS SharePoint

Marketing - 18 Years of Experience - Near 90066

PROFILE Team Mayday. I have grown existing accounts 150-200% on average, converted project based business to retainers, and landed new accounts for The Distillery Project, ZEESMAN, 9th I'm a seasoned senior digital agency Minute and the Marketing Arm from $100k to $20mm. Some clients include: Schmidt Peterson professional with more than 20 years in Motorsports, Wilson Athletics, Arrow Electronics (IoT/Cloud), Sony Pictures ...

Tags for this Online Resume: Financial, Financial Services, Services, Social Media, Business Development, Commercial Production, Consumer Products, e-Commerce, Electronics, Entertainment