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Online Resumes with "Manager Regulatory"
Clinical Project Manager and Regulatory Compliance
Director, Product Management
Searching for a mid to senior level Product Management position. I am currently employed but searching for a new position that can use my skills, abilities, and experience at Software Product Management. My experience and key strengths include: 1. Direct experience in the product management, design, development, and release of several commercial enterprise software products. Many industry leaders have adopted these prod...
North America Logistics Staff Manager Tank car, Truck, or Ship Loader - 20 Years of Experience - Near 77406, ISO, Greenbelt, 3PL
Successful in creating consultative business partnerships, assessing needs and overcome objectives by developing supply chain solutions through process improvement. Through collaboration with supply chain and customers have provided cost effective solutions that exceeds expectations. With a solid background in Logistics I have demonstrated the ability to manage regulatory compliance, while introducing and executing new con...
Tags for this Online Resume: Transportation, Distribution, Manufacturing, Purchasing, Support, Inventory, Supply Chain, 3PL, Green Belt, ISO, transportation, trucking
Clinical Research
ACCOMPLISHMENTS * Worked with 50 different sponsor and CRO companies on various GI studies * Managed Bunion investigational study with 300 patients. * Three FDA audits without 483. * Met all recruitment targets within required study timeframe * Managed regulatory binder for studies, post start-up * In depth knowledge of Microsoft packages ( Word, Excel and power point) Experienced with Oracle, Inform, Medidata eDC programs ...
Tags for this Online Resume: Oncology, Research, Clinical Research, Microsoft PowerPoint, Microsoft Word, Oracle, Recruiting, Staffing & Recruitment, Computer Aided Software Engineering, Good Clinical Practices
Director of Quality - 20 Years of Experience - Near 91709
SUMMARY OF QUALIFICATIONS * Over twenty years of experience managing regulatory affairs (RA)/quality assurance (QA), quality control (QC)/research & development (R&D) departments in pharmaceutical, medical device and dietary supplement manufacturing industries. Implemented Quality Management Systems meeting domestic and international regulatory requirements and ISO registration. Reviewed pre-clinical, clinical and pharmacok...
Ideal Companies: Pharmaceutical, Medical Device, Biomedical
Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Manufacturing, Regulatory Affairs, Microbiological Testing, Test, ISO, Pharmaceutical, ADA
General
SUMMARY Pharmaceutical Professional 20 years' experience, Quality Assurance, auditor batch review /release, Clinical Supplies, OTC and Governance meeting manager, worked in a Consent Decree environment with special projects, audit, and review and approve label change controls folders, Bill of Materials setup, master batch records, validation documentations. label inspection/review, quality notifications, produce/update sour...
Tags for this Online Resume: Manufacturing, Proofreading, Management, Packaging, Project Management, Audit, Distribution, Documentation, Inventory, Process Improvement
Business Analyst
SUMMARY: Over 25 years of experience in Business Process Modeling, Project Management, and Information Technology Service Management. Professional business analyst bringing a performance-based theory and experienced based approach to strategically designing and implementing quality gap-reducing interventions to information technology, organizational development, quality improvement and research requirements aligned with the...
Tags for this Online Resume: Management, Support, Project Management, Automation, Business Analysis, Business Analyst, Business Requirements, EPC, Extranet, Information Technology
Associate Director Regulatory Affairs
I am seeking an opportunity to continue working in Regulatory Operations focusing primarily on eCTD submissions and document management of Regulatory, Clinical, and Quality compliance documents.
Tags for this Online Resume: Regulatory Affairs, Regulatory Operations, eCTD Submissions, Clinical Trial Master Files, Quality Assurance, Document Management
Early/Mid Level Statistical Analyst, San Francisco
I have 6 years of experience in clinical trials and healthcare research with the past 4.5 of those in a program management position. I currently manage a bipolar and depression research program at the VA in Palo Alto and Stanford University Medical Center. Working in this program has been a valuable experience where I've had the opportunity to develop many new skills (grant writing, scientific writing in general, managemen...
Account Manager - 21 Years of Experience - Near 75071
Summary of Experience Vendor Relationship Management * Manage Regulatory Impact to LOB * Vendor compliance audits * Executive Presentation * Performance Scorecard Definition/Measurement * Statement of Work (SOW) Mortgage Servicing ( Team Building & Leadership ( Program Management * Budget & Cost Management ( Client Account Management ( Portfolio Retention Trending Analysis ( Establish & Maintaining Client Relationships ( Ef...
Tags for this Online Resume: Account Management, Business Analysis, Business Analyst, Business Process Management, Business Requirements, Communication Skills, Compliance, CSC, Financial, Financial Services
Fashion
QUALIFICATIONS PROFILE Results-driven, multifaceted, and methodical professional, with wide-ranging experience in business optimization, program management, and regulatory compliance. Effective at identifying industry best practices and providing innovative solutions and alternatives to resolve complex issues and problems and acquire organizational growth. Equipped with articulate communication, negotiation, and interperson...
Tags for this Online Resume: Product Development, Compliance, Inventory, Scheduling, Procurement, Sourcing, Budgeting, Construction, Custody, Financial
Training & Development Manager
Areas of Expertise Instructional Designer, Training Developer, Technical Writer, and Instructor with extensive experience developing and implementing training and performance solutions in military, energy, industrial, maritime and manufacturing environments. Hands on experience with: * Instructional Designer * Training Developer * Technical Writer * Instructor * Oil & Gas * Industrial * Manufacturing * Project Management * ...
Tags for this Online Resume: Compliance, Training, Manufacturing, Technical Writing, Documentation, Management, Project Management, System design, Technical Documentation
