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Online Resumes with "FDA Approval"



Health and Wellness consultant - 10 Years of Experience - Near 89081

Summary * Currently Clinical Research Coordinator. * One-year recruitment specialist for inpatient hospital research studies * 10 months Research Assistant * 13 + years Clinical Research Coordinator * 15 + years Phlebotomist/specimen processor * 5 + years Regulatory Documentation Assistant * 3 + years creating and implementing nursing care plan for diabetes patients * 2 + years hospital and long term care facilities experie...

Tags for this Online Resume: Insulin, Protocol, Clinical Research, Assessments, Centrifuge, Health Insurance Portability And Accountability Act, Inventory, Pulmonary, Documentation, Licensed Nurse

Sales Manager

Career Summary: * 10+ years of experience in Semiconductor Marketing Strategies and Sales, Field Operation, Product Management, Manufacturing, Technology Roadmap, Customer and Business Development. * 7+ years experience of research and development in field of: Semiconductor System, RF and Microwave Plasma Modeling, Wireless Device, Manufacturing Implementation, Sensory and Monte Carlo Statistical Simulation. * 3+ years expe...

Tags for this Online Resume: Support, Rf, Sales, Budget Control, Budgeting, Capital Equipment, Cardiovascular, Construct (App Dev Tool), Consultative Sales, Data Modeling

Program Manager

ACCOMPLISHMENTS Seven years Medical Device Experience * Led team for 510K FDA approval on a medical robotic stent delivery system * Launched Digital Signal Processor medical device, met medical device quality requirements, built strategic alliances, achieved 510K FDA approval, and improved market share 25% * Cut development time by 50%, coordinated groups in 3 countries for design reviews, developed parallel activity with c...

Tags for this Online Resume: Reviews, Risk Management, EMC, Management, Program Management, Risk Assessment, Macromedia Flash, Product Launch, Program Manager, Quality

Scientist - 15 Years of Experience - Near 10954

SUMMARY: * A pharmaceutical scientist with more than 15 years of experience supporting product development activities in an FDA regulated environment. * Seeking a position where my knowledge and skills in Pharmaceutical Product Development and CMC documentation can be applied with a potential for professional growth. * Skilled in the application of various physico-chemical analytical techniques in raw material and finished ...

Tags for this Online Resume: Enterprise Requirements Planning, Information Requests, Oracle, Oracle ERP, DSC, Product Development, Research, SAP, Filing, regulatory

Scientist - 15 Years of Experience - Near 10954

SUMMARY: * A pharmaceutical scientist with more than 15 years of experience supporting product development activities in an FDA regulated environment. * Seeking a position where my knowledge and skills in Pharmaceutical Product Development and CMC documentation can be applied with a potential for professional growth. * Skilled in the application of various physico-chemical analytical techniques in raw material and finished ...

Tags for this Online Resume: Enterprise Requirements Planning, Information Requests, Oracle, Oracle ERP, DSC, Product Development, Research, SAP, C Programming Language, Filing

Life Scientist - 15 Years of Experience - Near 20782

PROFESSIONAL SUMMARY Exceptional leader talented at building professional relationships, self-motivation and team goals. Technically-savvy with outstanding training and presentation skills. Motivated scientist with solid experience managing all levels of large scale projects, including budgeting and administration. Experienced Scientist professional with strong leadership and relationship-building skills. Meticulous Medical...

Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Manufacturing, Cellular, Documentation, Electrophoresis, ELISA, Therapy, Training

Life Scientist - 20 Years of Experience - Near 19335

Summary An experienced toxicologist with a successful track record supporting drug discovery research and development to progress biologic-based and/or small molecule drug candidate (s) through all phases of nonclinical development (Phase 1-4). Multiple successful NDA approvals, along with BLA approval for a respiratory biologic and successful IND submissions. Extensive and broad based expertise in conceptualizing and desig...

Tags for this Online Resume: Audit, Research, Test, Toxicology, Protocol, Compliance, Training, Evaluate, Medical, Medical Devices, oncology, protocol, pharmaceutical, ich, nonclinical, Regulatory Affairs, Quality Assurance, GXP

Life Scientist - 20 Years of Experience - Near 19335

Summary An experienced toxicologist with a successful track record supporting drug discovery research and development to progress biologic-based and/or small molecule drug candidate (s) through all phases of nonclinical development (Phase 1-4). Multiple successful NDA approvals, along with BLA approval and successful IND submissions. Extensive and broad based expertise in conceptualizing and designing nonclinical developmen...

Tags for this Online Resume: Audit, Research, Test, Toxicology, Protocol, Compliance, Training, Evaluate, Medical, Medical Devices

Software Engineer - 1 Years of Experience - Near 95008

QUALIFICATIONS: Experienced project architect/manager/engineer/ with thirty+ years of experience in design and testing Managed teams of three to twelve engineers in numerous electronics/software manufacturing companies Thirty-two years of diversified MS Windows application development ( Visual Studio C# Visual C++ C ) Designed first FDA approved automatic blood pressure regulator (AI expert system) for ICU patients IVAC Dev...

Tags for this Online Resume: Reliability, System design, WPF, SAN (Storage Area Network), Surgical, ICU, Microsoft Visual Studio, Structured Query Language, Microsoft SQL Server, Microsoft Windows

Featured Profile

Specialty Sales Representative-16 years Experience-Omaha, NE

Highly motivated, specialty sales representative, with a well documented sales history while promoting a variety of therapeutic products within the pharmaceutical and biotechnology markets.

Ideal Companies: Amgen, Genentech, Gilead, Genzyme, Johnson & Johnson, Calgene, Abbott Labs, Aptalis

Tags for this Online Resume: Pharmaceutical Sales, Buy and Bill , Hospital Sales , IV and IM, Omaha, Product Launches, Biotechnology Sales, Pharmaceutical, Sales, Gastroenterology

Featured Profile

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

Featured Profile

Director of Human Resources - 20 Years of Experience - Near 94538

Hello, I am looking for the next step in my career. I am looking for a progressive organization that values input and is in a state of change. I desire a leadership role where accomplishments are recognized and appreciated.

Tags for this Online Resume: Compensation, Generalist, Leader, Recruiting, Bio Pharmacy, Training and development, Benefits, Organizational Development, Job Matching, Human Resources, Technology