PhD Biostatistician with expertise in Regulatory (FAD and EMA activity), Data - Safety Monitoring in the Pharmaceutical and Medical Device Industries. Scientific Advisory Participant.Biotechnology FDA and EMA submission in the pharmaceutical and medical device industries.Biostatical litigation specific to pharmaceutical and medical devices.Pre- and Nonclinical, Phases I - IV in biostatistics, data management, statistical programming, and etechnology across various therapeutic areas.Analysis of over 420 clinical studies, with over 30 in Integrated Summary of Safety and Integrated Summary of Efficacy (ISS/ISE).Build effective innovative an...

Consultant for international and domestic shipping logistics, warehouse operations, transportation purchasing, sourcing, and carrier contract negotiations.Expert in Land Bridge container operations between West and East Coast ports.International and domestic experience in logistics, warehouse operations, transportation purchasing, sourcing, and carrier contract negotiations.Import - export logistics, dealing with non - vessel operating common carrier (NVOCC), freight forwarders, custom brokers and intermodal transportation.Multilingual with shipping and logistics experience in Asia, Latin America and Europe.

Leadership Development Consultant and Executive CoachExtensive consulting and leadership experience for domestic and international businesses with expertise in business and financial management that include: Leadership and organizational development; client relations; and management of complex consulting engagements.  Ability to quickly assess business needs, problem-solve and create innovative and profitable solutions. Providing tailored business and operations management solutions. Leadership Development Management Development High Potential Development New Manager Development Executive Coaching Succession Planning 360-Deg...

Consumer Product and Pharmaceutical Market Research Consultant, Specializing in Quantitative and Qualitative Marketing Research Among Consumers and Health Care Professionals.Concept/Positioning: Insight, benefits, RTB (Reason To Believe) optimization and claim sorts.Product: In home use, controlled store tests, test market pricing, color and taste tests.Communication: Copy testing, packaging, eye tracking and name tests.Category and market: Market segmentation and market structure.Tracking: Awareness and usage, advertising and equity.Panel: Syndicated and custom diaries.Multicultural: Hispanic custom and syndicated studies and retail p...

Pharmaceutical Regulatory Consultant with Broad SNDA, GMP, API Development Experience.Development of commercial manufacturing, FDA and international registration and approval for atracurium besylate, trifluoridine, bupropion hydrochloride, zidovudine, exosurf, mivacurium chloride, doxacurium chloride, pseudoephedrine hydrochloride, acrivastine, valciclovir, tramadol hydrochloride, topiramate, levofloxacin, surfaxin, vinorelbine tartrate and lamotrigine.Major process SNDAs for ofloxacin and leucovorin calcium.Regulatory documentation and approvals (FDA request for NDAs for grandfathered products) for digoxin, melphalan, azathioprine, thiogu...

Power Plant and Equipment Global Sales and Contracts Execution Expert - Profitable Growth, Crafting and Implementing Growth Strategies, and Customer RetentionPower plant business development and entry strategies for new sales markets in the transformers and power cores industries; (particularly Russian Federation and former CIS countries).Design, manufacture, and project management with focus to power plants, transformers, and reactors, (Distribution Transformers-DT) both oil and cast resin type, Power Transformers-(PT, shunt reactors and special transformers furnace, phase-shifting).Global sales and contracts execution for the power indus...

Ph.D. Chemical Engineer with Expertise in Fine Chemicals, Nanolayer Coating and Encapsulation, Controlled Delivery Systems, Carbon Nanotubes and Nano CompositesBusiness Process Excellence E2E: Sales and marketing, research and development-Engineering-system center operations.Chemical, materials, bio manufacturing processing.Technology innovation and transfer.Project Management.Certified supply chain professional (CSCP).Particle science and technology: Milling, dispersion, coating and encapsulation.Material handling in chemicals, electronics, polymers (film and fibers), pigment and coatings, food, biomaterials, and pharmaceuticals.Research...

New Medical Device Development and Marketing with Specific Focus in Catheters and Related DevicesInternational distribution network for differentiated medical devices.Design of marketable differentiated products.Training and managing marketing and sales personnel with a hands-on approach especially in export markets.Developing marketing and sales plans especially for global marketsVascular access for hemodialysis patients.Undisclosed Company, Senior Consultant, 2016 - PresentSenior Associate consultant assisting on major medical device project...

Product Commercialization Marketing Consultant in Biopharmaceutical, Medical Device and Medical Diagnostics Industries, Litigation - Support and Testifying ExpertBiopharmaceutical product commercialization, diagnostic and medical device markets with over 30 years of success.Over 20 years operational leadership in mid-size to large biopharmaceutical companies and established medical device firms.Marketing, market research, pricing and reimbursement, business planning, and sales, contributing to ten new product launches in the life science industry with consulting engagements and industry experience spanning thirteen therapeutic classes.Ad...

Deliver Management Consulting Services and CPA Providing; Financial Planning, Budgeting, Forecasting, Audits for the Military, Health Care, and Banking Industries ConsultingSummaryHighly proficient Certified Public Accountant bringing over 25 years of experience in financial planning, accounting and finance. Fund management, audit facilitation, business development and providing Technical Management Consulting. Restructuring, institutional strengthening, budgeting, forecasting, financial analysis, project management, contract negotiations, due diligence, strategic partnerships, and client relationship management.Project management and ch...