CCS Associates
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CCS Associates Employees
CCS Associates July 2013 - Present
CCS Associates September 2010 - July 2013
Anaerobe Systems 2009 - 2009
US Department of Commerce, NTIA 2009 - 2009
Skills
Regulatory Submissions, GCP, Sop, Medical Devices, Clinical Trials, Clinical Research, Regulatory Affairs, Clinical Development, Quality Assurance, IND, CRO, Clinical Study Design, Protocol, Pharmacology, Quality Control, Regulatory Requirements, Drug Development, Biochemistry, Chemistry, Pharmacokinetics, Regulations, Clinical Data Management, 21 CFR Part 11, CTMS, Pharmacovigilance, FDA, Biotechnology, Pharmaceutical Industry, Oncology, Life Sciences, SOP
Education
University of California, Santa Cruz 2010 — 2011
Certificate, Regulatory Affairs
University of California, Santa Cruz 2008 — 2010
Certificate, Clinical Trails Design and Management
San Jose State University
BA, Chemistry/Biochemistry
CCS Associates June 2015 - Present
Hetero Drugs Ltd June 2012 - June 2015
Pranay Therapeutics December 2008 - February 2009
Skills
Medical Device Product..., CDISC Standards, 510 K, PMA, IDE, CE marking, IND, NDA, BLA, Clinical Trials, Clinical Data Management, Statistical Programming, Regulatory Submissions, Quality Assurance, ANDA, Medical Devices, eCTD, GMP, Pharmaceutical Industry, Regulatory Affairs, Biotechnology
Education
Northeastern University 2010 — 2012
Master's degree, Regulatory Affairs in Drugs, Biologics and Medical Devices, 3.8/4.0
Osmania University 2006 — 2010
Bachelor's degree, Pharmacy, GPA - 3.8/4.0
CCS Associates December 2014 - Present
Education
University of the District of Columbia 2010 — 2012
MS
University of the District of Columbia 2008 — 2010
BS
Universidade Salvador 2004 — 2006
BS
CCS Associates March 2015 - Present
KMI Consulting Services April 2011 - Present
Marval Pharma Ltd. January 2013 - November 2014
CCS Associates July 1998 - March 2011
Sequus Pharmaceuticals, Inc. July 1989 - June 1998
Skills
Early Drug Development, Project Management, Regulatory Submissions, Regulatory Requirements, Clinical Trials, CMC development, Technical Writing, Experimental Design, Project Planning, Liposomes, Parenteral, Outlook, Budgets, Editing, Teamwork, Drug Development, FDA, Biotechnology, Clinical Development, GMP, Life Sciences, Oncology
Education
UCSC 1985 — 1989
Bachelor of Science (BS), Biochemistry and Molecular Biology
University of California, Santa Cruz 1985 — 1989
Biochemistry and Molecular Biology
Cepheid July 2015 - Present
Roche Molecular Systems July 2014 - June 2015
CCS Associates August 2012 - June 2014
Rasor Consulting Group March 2010 - August 2012
Entrovita, Inc. December 2009 - February 2010
San Jose State University August 2009 - December 2009
San Jose State University, Stem Cell Internships in Laboratory Based Learning (SCILL) June 2009 - December 2009
Tomic Trading Company July 2007 - September 2009
Agriculture and Livestock Service SAG 2006 - 2006
Universidad de la Frontera 2004 - 2004
Skills
Medical Devices, Biotechnology, Clinical Trials, Molecular Biology, Clinical Development, FDA, GCP, PCR, Lifesciences, Clinical Research, Immunology, Protocol, Sop, Oncology
Education
San Jose State University 2009 — 2011
MS, MPDM
Universidad Católica de Temuco 1998 — 2006
DVM
CCS Associates September 2015 - Present
Sunrun February 2015 - June 2015
Sunrun June 2014 - February 2015
Intero Real Estate Services January 2014 - May 2014
Velasco DeNardi Group September 2013 - December 2013
Santa Clara University September 2012 - June 2013
Little Dish June 2012 - August 2012
Santa Clara University October 2009 - March 2012
FCC Collision Centers June 2011 - September 2011
Santa Clara University September 2010 - March 2011
Skills
Public Relations, Microsoft Office, Customer Service, Facebook, Event Planning, PowerPoint, Social Networking, Research, Social Media, Public Speaking, Microsoft Word, Microsoft Excel, Editing, Social Media Marketing, Management, iMovie, Illustrator, Photoshop, WiX
Education
Santa Clara University 2009 — 2013
Bachelor of Arts (B.A.), Public Relations, Advertising, and Applied Communication
CCS Associates March 2015 - Present
CCS Associates June 2008 - Present
Skills
Customer Service, Clinical Trials, Clinical Research, Microsoft Office, Healthcare, Microsoft Excel, Pharmaceutical Industry, Research, PowerPoint, Microsoft Word, Medical Devices, Outlook
Education
The National Hispanic University 2011 — 2014
Master's degree, Education
California State University-East Bay 2002 — 2010
Bachelor's degree, Spanish Language and Literature
DataFinityGroup November 2013 - Present
Robert Half International January 2013 - November 2013
FriendFinder Networks, Inc. August 2007 - January 2012
FriendFinder Networks Inc. 2004 - 2006
FriendFinder Networks Inc. August 2002 - 2004
Clarent Corporation January 2001 - December 2001
NorthPoint Communications 1999 - January 2001
Northpoint Communications Ltd 1998 - 1999
Pacific Bell Internet 1998 - 1998
CCS Associates 1996 - 1998
Skills
Email Marketing, CAN-SPAM, Email Production, Social Media Marketing, Technical Support, Customer Service..., Affiliate Marketing, Dreamweaver, Photoshop, A/B testing, CSS, MySQL, Google Analytics, Web Analytics, HTML, User Interface Design, PPC, SEO, Perl, Web Design, CRM, JavaScript, Front-end, PHP, Online Advertising, CMS, HTML emails, Newsletter Production, E-commerce, User Experience
Education
University of California, Santa Cruz 2005 — 2007
Web Design and Development
San Jose State University
De Anza College
Chevron Federal Credit Union September 2015 - Present
CCS Associates September 2012 - May 2015
Technology Credit Union October 2004 - September 2012
Technology Credit Union October 2004 - August 2012
Santa Clara County Office of Education April 2004 - September 2004
FastRental.com July 2002 - April 2004
KLA-Tencor January 2001 - July 2003
Datamedic Corporation September 1998 - November 2000
Skills
SSRS, SSIS, SSAS, C#, VB.net, C++, Perl, Unix, Mac OS, SQL Server, Oracle and..., ARCU, SQL, Databases, Microsoft SQL Server, Data Warehousing, Oracle, SSIS, ASP.NET, Analysis Services, VB.NET, Web Applications, XML, C#, Crystal Reports, PHP, JavaScript, ETL, SharePoint, Visio, Business Intelligence, SSRS, Software Development, SDLC
Education
University of Massachusetts Boston 1988 — 1990
B.S, Computer Science
Foothill College 1986 — 1988
Certificate (of two years college training), Computer Science
Xerox May 2000 - Present
CCS Associates May 1997 - May 2000
Skills
MS Project, Word, Excel, PowerPoint, Captivate, HTML, Instructional Design, Needs Analysis, Web Project Management, Offshore Project..., International Project..., Technical Writing, Training & Development, Webcasting, Web Design, Web Development, Learning, Distance Learning, Blended Learning, Microsoft Word, Project Management, Employee Training, Learning Management..., Learning Management, ADDIE
Education
Allegheny College 1993 — 1997
BA, English
Visual Evidence Corporation June 2014 - Present
Radcom, Inc. February 2011 - June 2014
FIT Technologies / SchoolOne May 2008 - December 2011
Campus Outfitters May 2008 - July 2010
ERICO July 2006 - May 2008
iDesign and Delivery September 2001 - July 2006
Nordson Corporation June 1999 - September 2001
Bayer Diagnostics September 1993 - June 1999
Ciba Corning 1993 - 1999
CCS Associates March 1992 - September 1993
Skills
Graphic Design, Illustration, Flash, Web Design, Flyer Design, Social Media, Viral Marketing, Marketing Communications, Dreamweaver, Photoshop, Illustrator, InDesign, Animation, Technical Illustration, Adobe Creative Suite, Vector Illustration, Icon Design, Web Interface Design, Flash Websites, Line Art, Instructional Design, Lectora, Articulate Studio, User Interface Design, Brochures, Corporate Identity, Graphics, Branding & Identity, Flyers, Interaction Design, Logo Design, Layout
Education
Art Institute of Pittsburgh 1983 — 1985
Associate in Specialized Technology, Visual Communications
Software and Management
Other Training Seminars
The Search Agency August 2009 - Present
eProspecting, a Dominion Enterprises Division June 2001 - July 2009
Homeseekers.com June 2000 - May 2001
GenstarMedia 1998 - 2000
CCS Associates 1997 - 1998
Skills
Web Analytics, Online Marketing, PPC, SEM, Analytics, Conversion Optimization, Digital Marketing, Online Advertising, Affiliate Marketing, SEO, Google Adwords, Omniture, HTML, Landing Page..., Organic Search, MSN AdCenter, Google Analytics, Search Advertising, Software Support, Technical Project..., Data Analysis, Technical Support, Project Management, PHP, JavaScript, MySQL, Microsoft Office, Photoshop, Graphic Design, Client Interfacing, Technical Liaison, Email Marketing, Google Tag Manager, Web Tracking, DoubleClick for Search, DoubleClick for..., DoubleClick Campaign..., CRM
Education
University of California, Davis 1992 — 1997
BS, Environmental Toxicology
CCS Associates May 2006 - March 2015
Postini August 2005 - May 2006
Redwood City Dodge Dealer August 2004 - June 2005
Rebuilding Alliance June 2002 - June 2004
Skills
Microsoft Office, Access, PowerPoint, Office Equipment, Customer Service, Multi Tasking, Bilingual-English/Spanis..., Front Office, Ordering Office Supplies, Organization, Highly motivated..., Microsoft Excel, Adobe Acrobat, QuickBooks, Flash Animation, Sales, Tagalog, 508 compliant, Customer Engagement, Customer Satisfaction, Office Management, Office Administration, Outlook, Data Entry, Administration, Microsoft Word, Fax, Time Management
Education
Notre Dame de Namur University 2013 — 2015
Bachelor of Science (BS), Business Administration- Concentration in finance (in progress), GPA: 3.83
Cañada College 2011 — 2013
Associate of Science (A.S.), Accounting
CCS Associates August 2012 - Present
IntraBiotics Pharmaceuticals 1997 - 2001
Pharmacyclics 1993 - 1997
Penederm November 1992 - April 1994
Education
University of California, Davis 1987 — 1993
Ph.D., Pharmacology/Toxicology
University of California, Davis 1983 — 1987
B.S., Environmental Toxicology
Pinole Valley High School
Pinole Valley High School
Shih Family March 2008 - Present
ISTA Pharmaceuticals April 2003 - June 2008
CTL ImmunoTherapies September 2000 - January 2003
CCS Associates July 1998 - August 2000
Skills
Regulatory Affairs, Clinical Research, Clinical Trials, Clinical Development, GCP, Pharmaceutical Industry, CTMS, Drug Development, Oncology, Biotechnology, CRO, FDA, EDC, Ophthalmology, Lifesciences
Education
Stanford University 1993 — 1997
BS, Biology
Synata April 2013 - Present
Storylight Films October 2013 - Present
Orbit Baby Inc. 2004 - 2012
Roche Pharmaceuticals 1999 - 2001
CCS Associates 1998 - 1999
Skills
Business Development, Product Marketing, Project Management, Consumer Products, Customer Service, Inventory Management, Management, Strategic Planning, Marketing Strategy, Product Development, Entrepreneurship, Start-ups, Strategy, Strategic Partnerships, Leadership, Product Management, E-commerce, Cross-functional Team..., Social Media, Competitive Analysis, Social Media Marketing, SaaS, Product Launch, Go-to-market Strategy
Education
Santa Clara University - Leavey School of Business 2002 — 2007
Master of Business Administration (MBA), Finance, Management, Marketing
Santa Clara University 1994 — 1998
Bachelor of Science (BS), Biology, General
Robert Louis Stevenson
Alios BioPharma April 2015 - Present
Medivation March 2011 - April 2015
Facet Biotech (formerly PDL BioPharma) March 2008 - March 2011
PDL BioPharma, Inc. September 2007 - March 2008
Protein Design Labs, Inc 2001 - 2007
Covance 1998 - 2000
CCS Associates 1994 - 1998
Skills
Oncology, GCP, Clinical Trials, CTMS, Data Management, Protocol, Biotechnology, Clinical Development, Cancer, Sop, Regulatory Submissions, Medical Writing, Clinical Data Management, Clinical Monitoring, Clinical Research..., Clinical Research, SOP
Education
California State University-Hayward
BSN, Nursing
Zoetis January 2013 - Present
Pfizer Animal Health November 2009 - 2013
Pfizer Animal Health 2003 - November 2009
Pharmacia Animal Health 2000 - 2003
CCS Associates 1997 - 2000
National Animal Poison Control Center May 1993 - September 1996
Castle Shannon Veterinary Hospital May 1990 - May 1993
Bristol-Myers Squibb February 1984 - August 1986
Skills
Veterinary Medicine, GLP, Pharmaceutical Industry, Clinical Development, Clinical Trials, Drug Development, Regulatory Affairs, Toxicology, Regulatory Submissions, Oncology, FDA, GCP, Translational Medicine, IND, Medical Writing
Education
University of Illinois at Urbana-Champaign 1993 — 1997
PhD, Veterinary Biosciences
Purdue University 1986 — 1990
DVM, Veterinary Medicine
The University of Chicago 1981 — 1983
MS, Pharmacology & Physiology
Bucknell University 1977 — 1981
BS, Animal Behavior
Actelion November 2008 - Present
bayhill therapeutics November 2006 - November 2008
Johnson & Johnson February 2003 - August 2006
CV Therapeutics January 2002 - January 2003
CCS Associates June 1997 - January 2002
Roche Pharmaceuticals February 1996 - June 1997
Collagen Corp June 1993 - June 1995
syntex 1989 - 1993
Skills
Drug Safety, Clinical Trials, Clinical Development, GCP, Protocol, Clinical Research..., Drug Development, CRO, Medical Devices, MedDRA, Phase I, Oncology, FDA, Clinical Research, Biotechnology, Pharmaceutical Industry, CTMS, Pharmacovigilance, Life Sciences, ICH-GCP, CRF design
Education
City University of New York-Hunter College
BS Nursing, Nursing
New York University
MA, biophysical pathology
CCS Associates June 2011 - Present
Urigen Pharmaceuticals, Inc. 2004 - 2008
Education
Stanford University
PhD, Biological Sciences
University of California, Berkeley
BS, Molecular Plant Biology
Ardea Biosciences August 2012 - Present
Pfizer 2010 - August 2012
Chiltern International August 2006 - September 2009
PRACS Institute, Ltd. July 2005 - July 2006
PPD June 2002 - July 2004
VivoMetrics, Inc. July 2001 - July 2002
HemoTherapies, Inc. January 2000 - July 2001
CCS Associates May 1997 - January 2000
Medtronic August 1995 - May 1997
Skills
GCP, Regulatory Affairs, CRO, Clinical Research, CTMS, Clinical Trials, Clinical Development
Education
Southeast Missouri State University
BS, Biology
Britt Consulting, LLC June 2012 - Present
Pharm-Olam International 2014 - 2015
Pharm-Olam International 2014 - 2015
Synteract, Inc. July 2004 - June 2012
CCS Associates June 2000 - July 2004
Schering-Plough Research Institute 1999 - 2000
Kendle International 1997 - 1999
Skills
Clinical Trial..., Oncology, Clinical Research, Infectious Diseases, Pharmaceuticals, Clinical Monitoring, CRO, Medical Devices, Insomnia, Arthritis, Liver Disease, Nephrology, Gastroenterology, Endocrinology, Obesity, Diabetes, IND, NDA, Protocol Design, RECIST, Biotechnology, Hepatitis C, ICH-GCP, GCP Auditing, Photography, GCP, Clinical Development, CTMS, Clinical Study Design
Education
Eastern Kentucky University 1992 — 1994
BS, Biology and Chemistry
Eastern Kentucky University
Bachelor's degree, Biology, General
CCS Associates March 2015 - Present
Freelance Editing and Transcription January 1997 - Present
Unity Electric March 2013 - June 2014
Dow Jones & Co., Inc. October 2003 - December 2011
San Jose Medical Center January 2000 - January 2001
Dow Jones & Co., Inc January 1997 - January 2000
Infortal Associates 1995 - 1996
Skills
Editing, Proofreading, Copy Editing, Social Media, Writing, Analysis, PowerPoint, Microsoft Word, Sales, Newsletters, Publications, Blogging, Content Development, CRM, Public Relations, Publishing, Creative Writing, Research, Management, Content Management, Copywriting, Journalism, Social Networking, Microsoft Office
Education
San Francisco State University 1985 — 1989
BA, English/Creative Writing
California Notary Public
Palo Alto High School
Palo Alto High School
Palo Alto High School
Palo Alto High School
Dialog, LLC January 2010 - Present
ProQuest 2014 - 2015
Dialog, LLC August 2008 - December 2009
Thomson Scientific 2006 - 2008
Dialog 1997 - 2003
CCS Associates 1992 - 1997
Skills
Training, Competitive Intelligence, Information Retrieval, Research, Knowledge Management, Content Management, Management, Competitive Analysis, Library Instruction, Library Research, Strategic Planning, Library Science, Sales, Databases, Library, Information Literacy
Education
University of California, Davis
Environmental Toxicology
US Census Bureau April 2009 - June 2009
James Moore & Associates April 2007 - March 2008
Asian Americans for Community Involvement April 2005 - July 2006
Kelly Services June 2003 - August 2003
Network Associates May 2001 - March 2003
Nortel Networks January 1998 - March 2001
Newbridge Networks November 1995 - December 1997
SAT Corporation August 1994 - September 1995
CCS Associates March 1992 - August 1994
Volt Technical Services December 1991 - February 1992
Education
Miami University
B.A., Microbiology
CCS Associates June 2015 - Present
CCS Associates June 2012 - December 2014
CCS Associates August 2010 - June 2012
Griffel & Dorshow Chartered September 2004 - July 2010
Skills
Data Analysis, Microsoft Office, GCP, Clinical Trials, Clinical Development, Regulatory Submissions, Sop, CRO, Spanish, Project Management, FDA, Clinical Research, Microsoft Excel, Cross-functional Team...
Education
San Jose State University 2013 — 2016
MS in Medical Product Development Management
Winona State University 2001 — 2004
BS in Finance (cum laude); BS Business in Administration (cum laude)
Gilead Sciences March 2013 - Present
CCS Associates July 2011 - March 2013
CCS Associates June 2010 - June 2011
Johnson & Johnson GCO April 2008 - December 2009
Johnson & Johnson January 2007 - March 2008
Johnson & Johnson GCO November 2004 - December 2006
State Pharmacological Center of the MoH of Ukraine January 2003 - November 2004
Kyiv Municipal Clinical Hospital #12 August 1998 - December 2002
Skills
GCP, Biotechnology, SOP development, Clinical Trials, Pharmacovigilance, Clinical Operations, Drug Safety, Clinical Research, Pharmaceutical Industry, Sop, Oncology, Clinical Development, Cardiology, Quality Assurance, Project Management, Rheumatology, Infectious Diseases, Internal Medicine, Protocol, IND, SOP
Education
National Medical University 'O.O. Bogomolec', Kyiv 2000 — 2002
PhD, Cardiology
National Medical University 'O.O. Bogomolec', Kyiv 1992 — 1998
MD, General Medicine
UCSC
Certificate Program in Clinical Trials Design and Management
Relypsa October 2014 - Present
Relypsa December 2012 - September 2014
Relypsa September 2010 - December 2012
FibroGen September 2007 - September 2010
Biologics Consulting Group 2001 - 2007
Aviron 1999 - 2001
CCS Associates 1997 - 1999
Education
University of California, Irvine 1990 — 1996
B.S. Biology, Ecology and Evolutionary Biology Emphasis; Dance Minor
Blossom Shop April 2008 - Present
PDL BioPharma August 2006 - March 2008
ALZA Corporation August 2004 - August 2006
K-Force January 2004 - August 2004
SCIOS, Inc July 2001 - December 2003
CONNETICS Corporation July 2000 - May 2001
CCS Associates October 1998 - July 2000
Skills
SOP, CTMS, Pharmaceutical Industry, Biotechnology, Clinical Development, Clinical Trials, Oncology, FDA, Validation, GCP, Protocol, CRO
Education
San Francisco State University 1994 — 1997
BS, Marine Biology
San Francisco State University 1994 — 1997
Bachelor of Science, Marine Biology
Woodside Capital Partners March 2013 - May 2013
Centro de Estudos da Metrópole (CEM)/CEBRAP April 2012 - December 2012
CCS Associates July 2011 - February 2012
Children's Hospital Boston February 2008 - April 2011
Clinton Global Initiative 2010 - 2010
Skills
Data Analysis, Research, Microsoft Office, Matlab, Nonprofits, Analysis, Stata, Community Outreach, Economics, OpenClinica, Public Speaking, Financial Analysis, Policy Analysis, Public Health, Teaching, Grant Writing, Program Evaluation, Public Policy, R, Management
Education
Emory University School of Medicine 2013 — 2017
Doctor of Medicine (MD)
Harvard University 2007 — 2011
Bachelor's degree, Biomedical Engineering, African Studies
CCS Associates January 2015 - Present
CCSA 2009 - Present
Skills
DFSS Green Belt, Clinical Trials, GCP, CRO, Regulatory Documentation, Quality Auditing, Quality Assurance, ICH-GCP, Clinical Development, Pharmacovigilance, Pharmaceutical Industry, Six Sigma, Clinical Data Management, Oncology, Medical Devices, Project Management, CTMS, Case Report Forms, Infectious Diseases
Education
Dartmouth College
BA
University of Illinois at Chicago
MPH
CCS Associates 1994 - 1995
Education
Eidgenössische Technische Hochschule Zürich 1989 — 1992
Ph.D., Biology, in-vitro toxicology
Eidgenössische Technische Hochschule Zürich 1982 — 1986
Eidg. Dipl. Apothekerin
CCS Associates 2012 - Present
CCS Associates 2011 - 2012
CCS Associates 2009 - 2011
CCS Associates 2007 - 2009
CCS Associates September 2004 - 2007
Kidango, Inc. August 2001 - September 2004
Skills
Regulatory Submissions, Regulatory Affairs, Sop, GCP, Drug Safety
Education
Wheelock College
Master of Science (MS), Child Life and Family Centered Care
San Jose State University
Bachelor of Arts (B.A.), Psychology, minor in Child Development