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Online Resumes with "Regulatory Filing"
Postsecondary Teacher - 11 Years of Experience - Near 29376
CURRICULUM VITAE: Sharon Woodruff Team excellence instructor, facilitator, and trainer. Proven managerial, interpersonal, and training skills. Work History Title: Senior Clinical Research Associate Company/Location United BioSource Corporation Kansas City, MO/Regional United States Dates July 2014 - January 2015 Accountabilities Implement and monitor clinical trials for medications and devices to ensure sponsor and invest...
Tags for this Online Resume: South Carolina, Training, New Hire , Business, Education, Postsecondary, Excellence
Clinical Pharmacovigilance/Drug Safety - 20 Years of Experience - Near 95117
CAREER SUMMARY * Senior, seasoned pharmaceutical R&D professional with strong administrative, strategic & scientific planning, and coordination/execution skills, gained through 27 years of industrial experience in leading CMC technical development function (Pharmaceutics & Analytical), and leading global development & regulatory filings for NMEs (small molecule and biologics / mAb), and 505 (b) (2) products strong expertise...
Tags for this Online Resume: CMC, Product Development, Regulatory Affairs, Good Manufacturing Practices, Management, Project Management, Technical Lead, DP, Product Development, Supply Chain, Technical Operations
Financial Analyst
SUMMARY Goal oriented individual contributor with extensive experience in accounts payable, accounts receivable, regulatory filings, customer service, and contract administration in public utility and Fortune 500 corporations. Possess solid communication, team building, and problem-solving skills, and can adapt quickly to changes in organizational structure.
Tags for this Online Resume: Pricing, ACH, Gas Plants, Accounting, Microsoft Excel, Distribution, Financial, Management, Microsoft, Power (Os Enhancemnt Tool
Program Manager - 20 Years of Experience - Near 74145
Provide "on Demand" --any or all support needed for "full service" project management and consulting services as a contractor –I subcontract functions to specialists[ from 3 to as many as 60 subcontracts in a single project], and I provide support through all phases of projects from the feasibility planning to the final commissioning. I use all the MS Office programs, MS Projects etc... I have designed and implemented in...
Tags for this Online Resume: Customer Relationship Management, Inventory, Inventory management, Management, Budgeting, Compliance, Disaster Recovery, manager, Supply Chain Management, Coordinate subcontractor, management
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
Corporate Controller, Director of Accounting
Highly innovative Accountant with experience in all aspects of accounting and financial management, operational analysis and internal controls. Adept in the areas of financial reporting, budgeting and planning, knowledge of internal and system controls and system implementations. Strong organizational, communication and leadership abilities. Extensive experience in implementing Sarbanes-Oxley compliance requirements. Ver...
Ideal Companies: JP Morgan Chase, Fidelity Investments
Tags for this Online Resume: Audit, Accounting, Accounting Functions, Balance, Balance Sheet, Project Leader, Compensation, Financial, Financial Reporting, Implementation, Budget, Forecast, Microsoft Dynamics, SAP Concur, SAP, Version One, People Soft, FINOP, Regulatory Reporting, Revenue Recognition, Vendor Specific Objective Evidence
Professional Medical Education Specialist
An experienced educator of Medical and Academic professionals on diagnostic and therapeutic procedures that increase procedural, technology and product adoption to improve patient outcomes. Supports establishment and maintenance of customer relations with clinicians and medical societies. Initiates programs or projects based on identified business and/or tactical needs. Utilize problem solving skills to evaluate complex, di...
Ideal Companies: Web MD, Exact Sciences, Avanos Medical, Anthem, UCB, Acadia Pharmaceuticals, ASCO, Becton Dickenson, Boehringer Ingelheim, Change Healthcare, Stryker
Tags for this Online Resume: Inventory, Management, Tandem, LMS, Medical, Messaging, Science, ASCP, Hematology, medical writing, medical device, budgeting, Safety, Compliance review
