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Online Resumes with "emea"
Energetic, results-oriented individual with established credibility and respect at FDA and EMA. An extraordinary record which includes the lead and approval on New Drug Applications (NDA) and Marketing Authorization Application (MAA)
Global Regulatory Affairs leader for a combination of RA functions. Provides clear and specific regulatory input using skills(scientist, regulator and lawyer) to provide strategic planning decisions and implementation enabling successful drug approvals. Strong leader, expertise in DD, alignment with business goals, creative, proficient with complex frameworks and integration of abstract concepts in clinical and CMC areas o...
Tags for this Online Resume: Regulatory Affairs, small molecules, CDER, CBER, FDA, EMEA, IND, NDA, CTA, IMPD, proteins, anti-infectives, cardiovascular, pain, oncology, CMC, compliance, communicator, monoclonal antibodies , Biologics, Food and Drug, Global, eCTD, health authorities, alliance management, combination products, Biologics Biosimilars , Director , pharmaceutical , Leadership, Problem solving , Innovation, experienced, IND NDA CTA MAA, business goals , biologics - pharmaceutical , biosimilars
Senior Project Manager - 10+ years experience- Houston TX
Are you searching for a Project Manager with a proven ability to develop high-performance process improvements and technical innovations? If so, please consider my enclosed resume. I have delivered business analysis and project management services supporting large-scale applications and organizations. I take full responsibility for full lifecycle development of next-generation innovations, from initial requirement gather...
Ideal Companies: Any Company that has a IT Software Development Teams and need the experienced PM preferred on those who want to switch to Agile Methodologies
Tags for this Online Resume: C, Java, SQL, PL/SQL, ORACLE, UNIX, HPUX, SOLARIS, LINUX, Bourne SHELL, C SHELL, AWK, OOD, OOP, ASP .NET, ORACLE PERFORMANCE TUNING, INFORMIX, SCRUM, AGILE, WATERFALL, SDLC, DATA WAREHOUSE, DATA MODELING, DATA GOVERNANCE, MDM, 6 SIGMA, Tru 64 VM UNIX, VX WORKS, STL, RWT, UML, XML, MOTIF, CORBA, SNMP, CMIP, TCP/IP, ERWIN, TOAD, SUN Developer Workshop, Visio, Microsoft Project, Visual Studio, Microsoft Office, Microsoft Foundation Server, Sharepoint, Clear Case, Informatica, oracle dba, CMMI level 5, ORACLE RAC, ORACLE 11G, CDMA, GPRS, UMTS, IIS, Web Services, HTML, PMBOK
Sr. Director - Quality; Risk Management - 20 years experience
Highly qualified pharmaceutical executive, with expertise driving quality and compliance in global pharmaceutical GXP environments. Superior leadership, operations management, strategic planning and execution, and consensus building skills. Define, establish, implement, and continuously improve standard operating procedures (SOPs) and training programs to achieve compliance with corporate standards and industry regulations....
Tags for this Online Resume: Director, Vice President, Qualty, Compliance, Pharma, Bio Pharm
Biostatistician-6 years’ experience- SAS -SPSS - ICH & EMEA guidelines - Project Statistician -GSK/ICON/Freelancer
I'm a Biostatistician with Master's in Statistics and have over 6 years of experience in Clinical Research Domain. Expertise in writing Study report analysis plan, Statistical analysis (Generating Tables, listings and Graphs) using SAS and review of Clinical report and manuscript.
Document Specialist - 20 years experience - Philadelphia
Tags for this Online Resume: eCTD, IND, submission readiness, NDA, Document management , ICH, FDA, EMEA, SOP
Energetic and dynamic marketing professional open to new opportunities
Dynamic professional with progressive experience in directing complex projects, developing strategies to further to further enhance key initiatives. Adept at cultivating partnerships and building lasting relationships, and drives for results and excellence. Thrives in an agile, multi-tasked, fast paced and collaborative environment including experience in across all global business sectors Passionate, creative and detai...
Ideal Companies: Microsoft, Nike, Dell, Intel, Western Digital, Seagate, Nordstrom
Tags for this Online Resume: Proficient in Microsoft Office, Online Marketing, Marketing Professional, Detail Oriented, Event Management, Marketing Communications, Development of Training Programs, Shopper Marketing, Channel Development and Management, Social Media Marketing, Global Expertise, Vendor and Agency Management, Engaging Speaker and Presenter, Product Launches, Strategic Partnerships and Alliances, Sales Collateral Development
Quality Manager
I'm a Manufacturing Quality Manager with 25 years experience in pharmaceutical manufacturing, R&D, and validation. Expertise in seeing products through from R&D to market.
Tags for this Online Resume: Change Control, CAPA, Deviation, Audits, Quality, Validation, Management, Manufacturing, Packaging, SAP
Global Operations Manager
I am a multifaceted, accountable, results oriented individual with 12 years progressive experience in Operations, Facilities Management, Project Management, Acquisitions, Quality Assurance, Occupational Health and Safety, Disaster Relief and Real Estate Development in the Americas, Asia, Europe and Africa. As an Executive, Project Manager, Consultant and Department Head, I have provided oversight for a wide range of Real E...
Ideal Companies: CBRE, Jones Lang Lasalle, Deloitte
Tags for this Online Resume: Operations, Development, Facilities, Regional, Entitilements, Forecasting, Project, procurement, site, budget, permiting, planning, negotiation, management, resource
Experienced Project Manager, Functional and IT
Project Manager effective in leading and directing IT, Infrastructure, and Marketing projects from inception to launch. More than 16 years of progressive management experience and repeated success in developing project initiatives, directing project plans and achieving performance targets. 8+ years in a Program Management Office, PMO.
Ideal Companies: Marketo, Adobe, Wells Fargo, US Bank, Union Bank, PG&E, Oracle, American Express, AutoDesk, Allianz, Firemans Fund, Deloitte, Accenture, Slalom Consulting, Salesforce.com, Lyft, Uber, Kaiser Permanente
Tags for this Online Resume: Bay Area, Remote, Project Manager, San Francisco, Marin, PMO, Compliance, Program Manager, Functional Project Manager, IT Project Manager, MS Project, Primavera P6, Technology Implementation, Implementation, end to end, Process Design, Planning and Scheduling, Budgeting, Reporting, Marketing, Communication, Metrics, Management Presentations, Global Teams, MS Office, MAC OS, Visio, Lotus Notes, SAP, Oracle, SharePoint, RPM, Onelink, Remedy, Indonesia, Bahasa Indonesia, ERP, CRM
DATA MANAGEMENT ANALYST - 4.5 YEARS EXPERIENCE - Bangalore India
To work learn and grow with an organization to reach a high level in Regulatory Submission Management hierarchy and be instrumental in driving it beyond its mission by adhering to its values and cultures and utilizing my potential and talent to its fullest.
Tags for this Online Resume: Regualatory Publishing, Regulatory Affairs, Submission Manager, Health Authority , ISI Tool Box, eCTDXpress, ISI Publisher, Liquent, Insight Publisher, CMC Documentation, USFDA, EMEA, MHRA
Enterprise IT Infrastructure Client/Service Manager/Director
Dynamic IT Infrastructure Manager with more than 20 years’ experience designing, planning and maintaining data center operations. Proven expertise providing data center infrastructure and IT service management to high profile corporations and organizations. Skilled at server room migrations and consolidations, patch management, monitoring and system troubleshooting. Solid background in infrastructure design and layout, vend...
Tags for this Online Resume: DCIM, Data Center, Enterprise, Visio, DNS\WINS, Active Directory (AD), Change Control, Windows Server 2008/2003, SAN\NAS, LAN\MAN\WAN, TCPIP, VoIP, BMC, UPS\PDU, StarLine Busway, HP / IBM / DELL / Cisco, EMC / ISILON / CLARiiON, Troubleshooting / Critical Thinking / RCA, designing / deploying / supporting, Storage / Backup / Recovery / DR, Troubleshooting / Critical Thinking / Root Cause (RCA)
Compliance Advise & Assurance Advisor and Auditor - 11 Years of Experience - Near 19348
I was an auditor of activities within clinical drug development at AstraZeneca , having 11 years experience of a wide variety of audits such as for-cause, pharmacovigilance, clinical site and systems audits. My major accomplishments include FDA, EMEA and MHRA inspections, and I have led external audits in a range of countries and cultures, for example in USA, Canada, India, and many countries in EU and Latin America. I h...
Tags for this Online Resume: Quality Assurance, Auditor, Pharmacovigilance, Bilingual (Spanish-English), Inspection Readiness, Lead Data Manager, Supported Oncology trials
