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Clinical Regional Monitoring - 15 Years of Experience - Near 75219

Professional Summary Accomplished and energetic Senior Clinical Research Associate with a solid history of achievement in monitoring clinical trials. Motivated leader with strong organizational and prioritization abilities. Performed lead study duties to include trip report review and expense reporting. Mentored junior level CRAs and provided feedback and constructive critiques. Interested in senior positions as a research ...

Ideal Companies: Allergan, Bayer, CMED, Novartis, Pfizer, Paidion Research,

Tags for this Online Resume: Clinical Research, Research, Medical, Medical Records, Monitoring, Documentation, Protocol, Complaints, Nursing, Ophthalmology

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

Clinical Research Project Manager Interested in Growing with a Patient Centered Organization

​My career goal is to first obtain a clinical research project manager position with an innovative, patient-centered pharmaceutical company, medical device company, clinical research organization (CRO), or medical center. Eventually, I would like to prepare to segue into international development as a Senior Director and play an integral role in developing a research infrastructure for new companies and/or those interested ...

Ideal Companies: Pfizer, AstraZeneca, Becton Dickinson, etc.

Project Management and Testing Program Analysis - Tampa FL

Resourceful, innovative professional with over 10 years Project Management and Testing Program Analysis within both domestic and international arenas. Expertise in initiating projects and programs, boost efficiency and productivity while enhancing software quality and usability. A true hands-on Manager with proven skills in research, analysis, coordination, troubleshooting, negotiation, development and improvement of oper...

Ideal Companies: Chase, Climber.com, Raymond James, Citi, Yahoo, Apple, Ikea, Microsoft,

Tags for this Online Resume: HP QC, SQL, Documentation, Financial, Software Quality Assurance, Software Testing, Test, Test Plans, Audit, software, agile, Financial Analysis, Coordination, AML (Anti-Money Laundering), LATAM (Latin American), IT

QA Professional - Former FDA CDER 15 years experience, ASQ CQE, CQA, CQMgr-OE, Microbiologist,- DC

Former FDA CDER Compliance Officer with 15 years experience in Pharma QA seeks Leadership position in QA Regulatory Compliance, Investigations, Audits

Ideal Companies: Solvay, Sciele, Monsanto, ConAgra, Bayer, CR Bard, etc. Novartis, Shionogi, CIBA Vision, Alcon, Allergan, Coca Cola, Johnson and Johnson, Pfizer

Tags for this Online Resume: TrackWise, Investigations, CAPAs, APRs, Minitab, SPC, SAS-JMP/Discovery, SAP, QA, Compliance, Medical Device, Pharmaceuticals, Biotechnology

Environmental / Compliance Management Systems - 20 Years of Experience - Near 77077

Objective: A senior management position in which I will contribute to business value by developing and executing a strategic, long term vision in the area of environmental, health and safety. This ideal position will leverage existing leadership and influencing skills and provide the opportunity to play a direct role development of team members and stakeholders. Overview: Twenty-year Petrochemical and Oil & Gas Indust...

Ideal Companies: Oil and Gas Industry, Chemical Industry

Tags for this Online Resume: Environmental, Compliance, Regulatory, Management, Air, Waste, Water, Team Leader, Assessments, Audit

Pharma/Drug Safety (Research, Development)

Highly experienced, trained research and drug safety professional with extensive knowledge of FDA, EU and ICH regulations necessary to develop, study, and market medical drugs and devices. Public health professional with over 15 years of proven experience as a general physician, direct outpatient care and emergency medicine provider. Passionate about global health and drug safety. Adept in research, grant writing, public he...

Ideal Companies: Abbott, Medix, PRA health sciences, Catawba Research, Medpace, Acelity, Bellicum Pharmaceuticals, Covance, US Prahs, Novartis, Bayer, Integrated Resources INC, The University of Texas Sothwestern, Baylor Scott & White Health, Abbvie

Tags for this Online Resume: Public Health, Clinical Research, Data Analysis, Pharmacovigilance, FDA regulations, drug/device research and development, clinical trials, risk management, regulatory compliance, French language, Spanish language

I am a Regisered Nurse with interests and experience in Clinical Regional Monitoring and Clinical Management/Project Manager - 15 Years of Experience - Near 06512

I have a strong clinical background as a Registered Nurse prior to my joining the pharmaceutical industry. This has been beneficial in the course of my career. I have expertise in many areas and observational abilities in tracking subject safety and tolerability. I am aware of site challenges, having conducted clinical trials in large hospital settings as an RN and can be supportive and provide suggestions to sites when ch...

Ideal Companies: DOCs ICON Pfizer

Tags for this Online Resume: Clinical Research, Oncology, Immunology, Neuroscience, CRA, Registered Nurse, Clinical Manager, Data Management, Clinical Oversight, Project Management, CRO, CRO Oversight, GCP, ICH, Pharmaceutical Industry, Clinical Site Management, Compliance, Safety Management, Site Selection, Regulatory Compliance, Continuous Quality Improvement, Medical Writing, FDA Reporting, Trial Master File/eTMF, Cross-Functional Facilitation, Strategic Planning, Risk Analysis, Safety Oversight and Reporting, Data Targeted Review

Desired Job:​ Senior Scientist, Management, Regulatory Affairs

Brief Summary: I am a natural and experienced leader/manager. I demonstrated these abilities within my role at Howard University College of Medicine (HUCM) and the EPA. As an Assistant Professor (tenure-track) & Principal Investigator within HUCM, I managed a laboratory and research projects. Managing laboratory projects included providing funding through grant writing/approvals, hiring staff, ordering supplies, developing...

Ideal Companies: Syngenta, Pfizer, BASF, PPG, ThermoFisher, KimberlyClark, Lonza

Tags for this Online Resume: Toxicology, Management, Quality Assurance, Research, Project Manager, Senior Scientist, Program Manager, Regulatory Affairs

Physician Assistant

I would like a challenging job where I am constantly learning sometime new daily. I really enjoy educating all types of patients. I am comfortable performing physical examinations, including Pap smears and cervical cultures. I am comfortable performing medication teaching and supervising the signing of consent forms.

Ideal Companies: Ms., Ms., Ms.

Tags for this Online Resume: Health Care Industry, Insurance, Inventory, Management, Medical, Medical Records, OB/GYN, Physical Examination, Quality, Quality Assurance, Qualtiy Assurance, Power Point Presentations, Microsoft Word, Excel Spreadsheet

Executive Vice President - 20 Years of Experience

Mentoring, Reporting, KPI Management, Integrations, SOPs, Continuous Improvement, Risk Management, Safety Growth Initiatives, Presentations, Analyzing Data, Global Initiatives, CRM, SLA's, Logistics, Capital Expenditures Fast-Paced Environments, Crisis Management, Talent Management, Sales Plans, Communications, Accountability Multi-site, Global Operations Management, Kaizen Techniques, Project Planning, Pricing, Cost Contr...

Tags for this Online Resume: Financial Management, Management, Budgeting, Training, Budgetary, P&L, Strategic Vision, Human Resources, Employee Relationship/Culture, Strategic Planning and Execution, Operations Leadership, Change Management, Process Improvement, Project Management, Performance Development, Sales and Marketing Startegies, Capital Campaigns, Board Interaction and Leadership, Team Leadership and Development, Building/Facility Development, Client Management, Executive Leadership