Cardinal Health Regulatory Sciences
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Cardinal Health Regulatory Sciences Employees
Employee
Years
Job
Industry
Christine Baxter Christine Baxter's Cardinal Health Regulatory Sciences Experience January 2009 - Present
Job Regulatory Submission Operations Manager at Cardinal Health Regulatory Sciences
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences January 2009 - Present
Beckloff Associates, Inc. January 2005 - January 2009
Quintiles 2003 - 2005
Quintiles January 1999 - January 2003
Hoechst Marion Roussel Inc. January 1995 - January 1999
Marion Merrel Dow January 1994 - January 1995
Skills
Electronic/Paper..., SPL, Computer System..., Publishing Application..., Publishing System..., Template..., Regulatory Affairs, Validation, Regulatory Requirements, FDA, Sop, GLP, Biotechnology, CRO
Education
DeVry University 1998 — 2003
BS, Computer Information Systems
Cardinal Health Regulatory Sciences January 2009 - Present
Beckloff Associates, Inc. January 2005 - January 2009
Quintiles 2003 - 2005
Quintiles January 1999 - January 2003
Hoechst Marion Roussel Inc. January 1995 - January 1999
Marion Merrel Dow January 1994 - January 1995
Skills
Electronic/Paper..., SPL, Computer System..., Publishing Application..., Publishing System..., Template..., Regulatory Affairs, Validation, Regulatory Requirements, FDA, Sop, GLP, Biotechnology, CRO
Education
DeVry University 1998 — 2003
BS, Computer Information Systems
Lindsay Reis's Cardinal Health Regulatory Sciences Experience September 2015 - Present
Job
Industry Writing and Editing
Experience
Cardinal Health Regulatory Sciences September 2015 - Present
St. Louis Town Planner 2008 - 2010
Skills
Creative Writing, Leadership, Poetry, Literature, Art, Music, Blogging, Facebook, Social Networking, Graphic Design, Customer Service, Marketing, Social Media Marketing, Microsoft Office, Editing, Social Media, Microsoft Excel
Education
University of Denver 2009 — 2014
Master of Liberal Studies, Creative Writing
Boston University 2007 — 2009
Master of Science (M.S.), Banking and Financial Services Management
Drury University 2001 — 2006
Bachelor of Arts (B.A.), Advertising, Public Relations
Cardinal Health Regulatory Sciences September 2015 - Present
St. Louis Town Planner 2008 - 2010
Skills
Creative Writing, Leadership, Poetry, Literature, Art, Music, Blogging, Facebook, Social Networking, Graphic Design, Customer Service, Marketing, Social Media Marketing, Microsoft Office, Editing, Social Media, Microsoft Excel
Education
University of Denver 2009 — 2014
Master of Liberal Studies, Creative Writing
Boston University 2007 — 2009
Master of Science (M.S.), Banking and Financial Services Management
Drury University 2001 — 2006
Bachelor of Arts (B.A.), Advertising, Public Relations
Blythe Roberts's Cardinal Health Regulatory Sciences Experience July 2014 - June 2015
Job Sr. Specialist, Product or Services Marketing at Cardinal Health
Industry Pharmaceuticals
Experience
Cardinal Health Specialty Solutions July 2015 - Present
Cardinal Health Regulatory Sciences July 2014 - June 2015
Cardinal Health Regulatory Sciences February 2013 - July 2014
Cardinal Health Regulatory Sciences May 2012 - February 2013
Interim HealthCare May 2011 - August 2011
Skills
Marketing, Regulatory Submissions, Pharmaceutical Industry, Business Development, Proposal Writing, Salesforce.com, Project Management, Trade Shows, Microsoft Office, Adobe Acrobat, Lead Generation
Education
Baker University 2013 — 2015
Master of Business Administration (M.B.A.)
University of Kansas 2008 — 2012
Bachelor of Science (B.S.), Journalism, Strategic Communications
Cardinal Health Specialty Solutions July 2015 - Present
Cardinal Health Regulatory Sciences July 2014 - June 2015
Cardinal Health Regulatory Sciences February 2013 - July 2014
Cardinal Health Regulatory Sciences May 2012 - February 2013
Interim HealthCare May 2011 - August 2011
Skills
Marketing, Regulatory Submissions, Pharmaceutical Industry, Business Development, Proposal Writing, Salesforce.com, Project Management, Trade Shows, Microsoft Office, Adobe Acrobat, Lead Generation
Education
Baker University 2013 — 2015
Master of Business Administration (M.B.A.)
University of Kansas 2008 — 2012
Bachelor of Science (B.S.), Journalism, Strategic Communications
G. Catherine Wight G. Catherine Wight's Cardinal Health Regulatory Sciences Experience September 2014 - Present
Job Scientist III, Regulatory Affairs & Product Development
Industry Research
Experience
Cardinal Health Regulatory Sciences September 2014 - Present
Care Communications, Inc. January 2013 - September 2014
Beckloff Associates March 2013 - June 2013
Kansas City Cancer Center/University of Kansas Cancer Center October 2004 - January 2013
Regulatory Clinical Consultants, Inc. 1998 - 2005
Durst and Associates 1997 - 1998
Park Lane Medical Center 1993 - 1997
Truman Medical Centers 1989 - 1993
St. Luke's Health System 1984 - 1989
Skills
GCP, Oncology, Clinical Trials, Clinical Research, Microsoft Office, EDC, Clinical Data Management, Quality Assurance, Clinical Development, ICH-GCP, CTMS, Healthcare, Regulatory Affairs, Data Management, CRO, HIPAA, Healthcare Information..., Quality Auditing, Medical Records, EMRs, Adobe, Pharmaceutical Industry, FDA, Protocol, Health Policy, Research, Clinical Monitoring, Therapeutic Areas, Infectious Diseases
Education
University of Missouri-Kansas City 1992 — 1995
MBA, Management
Avila University
BA, Public Administration
Longview Community College
AA, General
Cardinal Health Regulatory Sciences September 2014 - Present
Care Communications, Inc. January 2013 - September 2014
Beckloff Associates March 2013 - June 2013
Kansas City Cancer Center/University of Kansas Cancer Center October 2004 - January 2013
Regulatory Clinical Consultants, Inc. 1998 - 2005
Durst and Associates 1997 - 1998
Park Lane Medical Center 1993 - 1997
Truman Medical Centers 1989 - 1993
St. Luke's Health System 1984 - 1989
Skills
GCP, Oncology, Clinical Trials, Clinical Research, Microsoft Office, EDC, Clinical Data Management, Quality Assurance, Clinical Development, ICH-GCP, CTMS, Healthcare, Regulatory Affairs, Data Management, CRO, HIPAA, Healthcare Information..., Quality Auditing, Medical Records, EMRs, Adobe, Pharmaceutical Industry, FDA, Protocol, Health Policy, Research, Clinical Monitoring, Therapeutic Areas, Infectious Diseases
Education
University of Missouri-Kansas City 1992 — 1995
MBA, Management
Avila University
BA, Public Administration
Longview Community College
AA, General
Boyd Lund's Cardinal Health Regulatory Sciences Experience May 2014 - Present
Job Director, CMC; Cardinal Health Regulatory Sciences
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences May 2014 - Present
Beckloff Associates/Cardinal Health September 2004 - May 2014
Quintiles, Inc. (Kansas City) November 2003 - September 2004
CyDex, Inc. October 2000 - October 2003
Oread Labs June 1990 - October 2000
Skills
Regulatory Affairs, GLP, Quality Assurance, FDA, GMP, Validation, SOP, cGMP, Pharmaceuticals, Regulatory Submissions, Auditing, Pharmaceutical..., Change Control, IND, Quality Auditing, Pharmaceutical Industry, Sop, Analytical Chemistry
Education
The University of Kansas 1987 — 1991
BS, Cell Biology
Cardinal Health Regulatory Sciences May 2014 - Present
Beckloff Associates/Cardinal Health September 2004 - May 2014
Quintiles, Inc. (Kansas City) November 2003 - September 2004
CyDex, Inc. October 2000 - October 2003
Oread Labs June 1990 - October 2000
Skills
Regulatory Affairs, GLP, Quality Assurance, FDA, GMP, Validation, SOP, cGMP, Pharmaceuticals, Regulatory Submissions, Auditing, Pharmaceutical..., Change Control, IND, Quality Auditing, Pharmaceutical Industry, Sop, Analytical Chemistry
Education
The University of Kansas 1987 — 1991
BS, Cell Biology
Carolyn Rynard Carolyn Rynard's Cardinal Health Regulatory Sciences Experience June 2006 - Present
Job Pharmaceutical Development
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences June 2006 - Present
Halozyme Therapeutics, Inc. 2003 - 2006
Medinox, Inc. 2001 - 2003
Amylin Pharmaceuticals, Inc. 1993 - 2001
Baxter Healthcare 1987 - 1993
Du Pont 1982 - 1987
Education
Stanford University 1977 — 1981
PhD, Chemical physics
Cardinal Health Regulatory Sciences June 2006 - Present
Halozyme Therapeutics, Inc. 2003 - 2006
Medinox, Inc. 2001 - 2003
Amylin Pharmaceuticals, Inc. 1993 - 2001
Baxter Healthcare 1987 - 1993
Du Pont 1982 - 1987
Education
Stanford University 1977 — 1981
PhD, Chemical physics
Korie Osborn's Cardinal Health Regulatory Sciences Experience March 2015 - Present
Job Manager, Quality Assurance
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences March 2015 - Present
Acceleration Laboratory Services, Inc. October 2014 - March 2015
Acceleration Laboratory Services, Inc. September 2013 - September 2014
Acceleration Laboratory Services, Inc. March 2008 - August 2013
Aptuit 2007 - 2008
Pfizer 2004 - 2007
Pfizer 2000 - 2004
Skills
GMP, GLP, Sop, Validation, FDA, HPLC, Pharmaceutical Industry, CRO, 21 CFR Part 11, Quality Assurance, Quality System, Change Control, GxP, Analytical Chemistry, CAPA, SOP
Education
Baker University 2005 — 2007
MBA, Business
University of Central Missouri 1995 — 1999
BS, Biology, Chemistry
Cardinal Health Regulatory Sciences March 2015 - Present
Acceleration Laboratory Services, Inc. October 2014 - March 2015
Acceleration Laboratory Services, Inc. September 2013 - September 2014
Acceleration Laboratory Services, Inc. March 2008 - August 2013
Aptuit 2007 - 2008
Pfizer 2004 - 2007
Pfizer 2000 - 2004
Skills
GMP, GLP, Sop, Validation, FDA, HPLC, Pharmaceutical Industry, CRO, 21 CFR Part 11, Quality Assurance, Quality System, Change Control, GxP, Analytical Chemistry, CAPA, SOP
Education
Baker University 2005 — 2007
MBA, Business
University of Central Missouri 1995 — 1999
BS, Biology, Chemistry
Amy Hess's Cardinal Health Regulatory Sciences Experience March 2015 - Present
Job Scientific consultant at Cardinal Health
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences March 2015 - Present
Catalent Pharma Solutions August 1999 - March 2015
Aptuit 2005 - 2012
Quintiles August 1999 - October 2005
Midwest Research Institute May 1995 - August 1999
Skills
GMP, Sop, Validation, GLP, 21 CFR Part 11, FDA, CAPA, HPLC, Drug Development, Analytical Chemistry, Change Control
Education
The University of Kansas 1988 — 1993
BS, Environmental Science
University of Kansas 1988 — 1993
Bachelor of Applied Science (B.A.Sc.), Environmental Science
Cardinal Health Regulatory Sciences March 2015 - Present
Catalent Pharma Solutions August 1999 - March 2015
Aptuit 2005 - 2012
Quintiles August 1999 - October 2005
Midwest Research Institute May 1995 - August 1999
Skills
GMP, Sop, Validation, GLP, 21 CFR Part 11, FDA, CAPA, HPLC, Drug Development, Analytical Chemistry, Change Control
Education
The University of Kansas 1988 — 1993
BS, Environmental Science
University of Kansas 1988 — 1993
Bachelor of Applied Science (B.A.Sc.), Environmental Science
Ana Barata Ana Barata's Cardinal Health Regulatory Sciences Experience September 2015 - Present
Job Specialist II, Regulatory Submissions Ops at Cardinal Health
Industry Publishing
Experience
Cardinal Health Regulatory Sciences September 2015 - Present
Cardinal Health Regulatory Sciences February 2012 - September 2015
JCMH May 2005 - February 2012
Johnson County Mental Health May 2005 - February 2012
Sabates Eye Center July 2003 - May 2005
Professional Eye Care April 2003 - July 2003
US Army August 1994 - February 2002
U.S. Army January 2000 - January 2002
Skills
EMR, Medical Records, HIPAA, Emergency Management, Microsoft Office, Pharmaceutical Industry, Mental Health, Public Speaking, Process Scheduler, Human Resources, Microsoft Excel, Spreadsheets, Medical Terminology, Microsoft Word, Project Management, Cpr Certified, Outlook, Regulatory Submissions, FDA, Regulatory Affairs, Documentations, Teamwork, Regulatory Requirements, Team Building, Volunteer Management, Critical Thinking, Time Management, Quality Assurance, IND, Validation, Spanish, Administration, Coaching, Community Outreach, Customer Service, Data Entry, Filing, Healthcare, Hospitals, Invoicing, PowerPoint, Strategic Planning, Treatment
Education
University Of Phoenix Axia College2009 2008 — 2009
Associates' Degree, Health Care Administration
University of Phoenix 2008 — 2009
Associates, Health Care Administration
Ali Kemp Educational Foundation 2006 — 2006
certificate, Beginning ASL
Johnson County Human Services and Aging2006 2006 — 2006
Associate's degree, Health/Health Care Administration/Management
University of Maryland University College
Landstuhl Regional Medical Center
Central Texas College
Associate
Mount Vernon High School 1990 — 1994
Diploma
Mount Vernon High School 1990 — 1994
Diploma
American Academy of OphthalmologyKansas
Certificate, Self Defense
Cardinal Health Regulatory Sciences September 2015 - Present
Cardinal Health Regulatory Sciences February 2012 - September 2015
JCMH May 2005 - February 2012
Johnson County Mental Health May 2005 - February 2012
Sabates Eye Center July 2003 - May 2005
Professional Eye Care April 2003 - July 2003
US Army August 1994 - February 2002
U.S. Army January 2000 - January 2002
Skills
EMR, Medical Records, HIPAA, Emergency Management, Microsoft Office, Pharmaceutical Industry, Mental Health, Public Speaking, Process Scheduler, Human Resources, Microsoft Excel, Spreadsheets, Medical Terminology, Microsoft Word, Project Management, Cpr Certified, Outlook, Regulatory Submissions, FDA, Regulatory Affairs, Documentations, Teamwork, Regulatory Requirements, Team Building, Volunteer Management, Critical Thinking, Time Management, Quality Assurance, IND, Validation, Spanish, Administration, Coaching, Community Outreach, Customer Service, Data Entry, Filing, Healthcare, Hospitals, Invoicing, PowerPoint, Strategic Planning, Treatment
Education
University Of Phoenix Axia College2009 2008 — 2009
Associates' Degree, Health Care Administration
University of Phoenix 2008 — 2009
Associates, Health Care Administration
Ali Kemp Educational Foundation 2006 — 2006
certificate, Beginning ASL
Johnson County Human Services and Aging2006 2006 — 2006
Associate's degree, Health/Health Care Administration/Management
University of Maryland University College
Landstuhl Regional Medical Center
Central Texas College
Associate
Mount Vernon High School 1990 — 1994
Diploma
Mount Vernon High School 1990 — 1994
Diploma
American Academy of OphthalmologyKansas
Certificate, Self Defense
Jamie Blaylock's Cardinal Health Regulatory Sciences Experience January 2011 - Present
Job Manager, Quality Document Systems Management at Cardinal Health
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences January 2011 - Present
Beckloff Associates (a CardinaL Health Co) 2007 - January 2011
Lawrence Chamber of Commerce 2006 - 2007
Celliance (a Serologicals Company) 2004 - 2006
Quintiles 2001 - 2004
Oread 1992 - 2001
Skills
Management, Supervisory Skills, data collation, Regulatory Submissions, SOP administration, Microsoft Office, Adobe Acrobat, GLP, Document Management, Change Control, Master Control, Team Leadership, Quality Assurance, GMP, Sop, Pharmaceutical Industry, Quality System, Microsoft Excel
Education
Johnson County Community College
AA, Liberal Arts and Sciences
Cardinal Health Regulatory Sciences January 2011 - Present
Beckloff Associates (a CardinaL Health Co) 2007 - January 2011
Lawrence Chamber of Commerce 2006 - 2007
Celliance (a Serologicals Company) 2004 - 2006
Quintiles 2001 - 2004
Oread 1992 - 2001
Skills
Management, Supervisory Skills, data collation, Regulatory Submissions, SOP administration, Microsoft Office, Adobe Acrobat, GLP, Document Management, Change Control, Master Control, Team Leadership, Quality Assurance, GMP, Sop, Pharmaceutical Industry, Quality System, Microsoft Excel
Education
Johnson County Community College
AA, Liberal Arts and Sciences
Mac McGuire's Cardinal Health Regulatory Sciences Experience September 2014 - Present
Job Medical Writing Manager at Cardinal Health Regulatory Sciences
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences September 2014 - Present
PRA Health Sciences November 2012 - September 2014
NIH June 2010 - November 2012
University of Kansas August 2005 - May 2010
Education
The University of Kansas 2005 — 2010
PhD, Neurosciences
Pacific University 2002 — 2005
BS, Biology
Wartburg College 2001 — 2002
Biology
Crook County High School 1997 — 2001
Cardinal Health Regulatory Sciences September 2014 - Present
PRA Health Sciences November 2012 - September 2014
NIH June 2010 - November 2012
University of Kansas August 2005 - May 2010
Education
The University of Kansas 2005 — 2010
PhD, Neurosciences
Pacific University 2002 — 2005
BS, Biology
Wartburg College 2001 — 2002
Biology
Crook County High School 1997 — 2001
Raymond Cerny's Cardinal Health Regulatory Sciences Experience March 2015 - Present
Job Sr. Scientist, Chemistry, Mfg & Cntrl at Cardinal Health
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences March 2015 - Present
Protocol Link, Inc. February 2007 - February 2015
Clearant, Inc. 2005 - 2007
Sartorius 2002 - 2005
Pall Life Sciences 1993 - 2000
Skills
Validation, CAPA, GMP, Pharmaceutical Industry, Quality Assurance, Regulatory Submissions, FDA, Medical Devices, Technical Writing, Filtration, ISO 13485, eCTD, Process Improvement, Microsoft Office, Manufacturing, Aseptic Processing, Technology Transfer, Biopharmaceuticals, V&V, Compliance, Complaint Investigations, CMC, Qualification, Strategy, Microbiology, Change Control, SOP, Deviation Management, Quality System, Regulatory Affairs, MS Office, Outlook, Lotus Notes, eCTDXpress, Documentum, SharePoint, ISI Toolbox, Adobe Acrobat
Education
Roosevelt University 1990 — 1994
MBA, International Business
Iowa State University 1983 — 1986
BS, Chemical Engineering
College of Lake County 1981 — 1983
Pre-Engineering
St Mary
St Mary
Cardinal Health Regulatory Sciences March 2015 - Present
Protocol Link, Inc. February 2007 - February 2015
Clearant, Inc. 2005 - 2007
Sartorius 2002 - 2005
Pall Life Sciences 1993 - 2000
Skills
Validation, CAPA, GMP, Pharmaceutical Industry, Quality Assurance, Regulatory Submissions, FDA, Medical Devices, Technical Writing, Filtration, ISO 13485, eCTD, Process Improvement, Microsoft Office, Manufacturing, Aseptic Processing, Technology Transfer, Biopharmaceuticals, V&V, Compliance, Complaint Investigations, CMC, Qualification, Strategy, Microbiology, Change Control, SOP, Deviation Management, Quality System, Regulatory Affairs, MS Office, Outlook, Lotus Notes, eCTDXpress, Documentum, SharePoint, ISI Toolbox, Adobe Acrobat
Education
Roosevelt University 1990 — 1994
MBA, International Business
Iowa State University 1983 — 1986
BS, Chemical Engineering
College of Lake County 1981 — 1983
Pre-Engineering
St Mary
St Mary
Brandi Heinrich's Cardinal Health Regulatory Sciences Experience July 2015 - Present
Job Specialist I, Regulatory Submissions Operations at Cardinal Health Regulatory Sciences
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences July 2015 - Present
Skills
Management, Microsoft Office, Customer Service, Training, Microsoft Excel, Project Management, Social Media, Social Media Marketing, Pharmaceutical Industry, FDA, Leadership, Microsoft Word, Event Management, Marketing Communications, Advertising, Clinical Trials, Regulatory Submissions, Regulatory Publishing, Document Management, Client Relations
Education
University of Kansas 2006 — 2010
Bachelor of Science (B.Sc.), Marketing
Cardinal Health Regulatory Sciences July 2015 - Present
Skills
Management, Microsoft Office, Customer Service, Training, Microsoft Excel, Project Management, Social Media, Social Media Marketing, Pharmaceutical Industry, FDA, Leadership, Microsoft Word, Event Management, Marketing Communications, Advertising, Clinical Trials, Regulatory Submissions, Regulatory Publishing, Document Management, Client Relations
Education
University of Kansas 2006 — 2010
Bachelor of Science (B.Sc.), Marketing
Nancy Bunn's Cardinal Health Regulatory Sciences Experience 2013 - 2015
Job Experienced Accounting Professional
Industry Accounting
Experience
Cardinal Health Regulatory Sciences 2013 - 2015
Beckloff Associates, Inc. (a Cardinal Health Company) 2012 - 2013
Beckloff Assoiciates, Inc. (A Cardinal Health Company) 2006 - 2012
Skills
Accounting, Financial Statement..., General Journal, General Ledger, Account Reconciliation, Inter/Intra Company..., Financial Analysis, Budgeting, Accounts Receivable, Cash Receipts, Collections, Accounts Payable, Payroll Administration, Payroll Taxes, Cash Management, Balance Sheet Review, Internal Theft..., Microsoft Office, SAP ERP, QuickBooks, Kronos Timekeeping, Best Fixed Assets, Workday, Pharmaceutical Industry, Manufacturing, Restaurants, Convenience Stores
Education
Platt Business College
Diploma, Accounting and Business/Management
The University of Kansas
Social Work
Cardinal Health Regulatory Sciences 2013 - 2015
Beckloff Associates, Inc. (a Cardinal Health Company) 2012 - 2013
Beckloff Assoiciates, Inc. (A Cardinal Health Company) 2006 - 2012
Skills
Accounting, Financial Statement..., General Journal, General Ledger, Account Reconciliation, Inter/Intra Company..., Financial Analysis, Budgeting, Accounts Receivable, Cash Receipts, Collections, Accounts Payable, Payroll Administration, Payroll Taxes, Cash Management, Balance Sheet Review, Internal Theft..., Microsoft Office, SAP ERP, QuickBooks, Kronos Timekeeping, Best Fixed Assets, Workday, Pharmaceutical Industry, Manufacturing, Restaurants, Convenience Stores
Education
Platt Business College
Diploma, Accounting and Business/Management
The University of Kansas
Social Work
Jenny Palin's Cardinal Health Regulatory Sciences Experience February 2015 - Present
Job Senior Coordinator, Document Systems Management Regulatory Sciences Specialty Solutions at Cardinal Health
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences February 2015 - Present
U.S. Engineering Company April 2013 - January 2015
Olsson Associates March 2012 - February 2013
HNTB August 2010 - November 2011
VML April 2002 - August 2010
Skills
Subcontracting, Accounting, Outlook, Data Entry, Time Management, Financial Reporting, Process Improvement, Budgets, Invoicing, Microsoft Excel, Analysis, Account Reconciliation, Accounts Receivable, General Ledger, Administrative..., Training, Auditing, Office Administration
Education
Johnson County Community College 1995 — 1996
High School, General Studies
The University of Kansas 1993 — 1995
High School, Graphic Design
Shawnee Mission West High School 1990 — 1993
High School, General Studies
Cardinal Health Regulatory Sciences February 2015 - Present
U.S. Engineering Company April 2013 - January 2015
Olsson Associates March 2012 - February 2013
HNTB August 2010 - November 2011
VML April 2002 - August 2010
Skills
Subcontracting, Accounting, Outlook, Data Entry, Time Management, Financial Reporting, Process Improvement, Budgets, Invoicing, Microsoft Excel, Analysis, Account Reconciliation, Accounts Receivable, General Ledger, Administrative..., Training, Auditing, Office Administration
Education
Johnson County Community College 1995 — 1996
High School, General Studies
The University of Kansas 1993 — 1995
High School, Graphic Design
Shawnee Mission West High School 1990 — 1993
High School, General Studies
Will Nelson Will Nelson's Cardinal Health Regulatory Sciences Experience January 2015 - Present
Job Senior Consultant with Cardinal Health Regulatory Sciences
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences January 2015 - Present
Validant March 2011 - December 2014
Aptuit April 2010 - February 2011
Cedarburg Hauser Pharmaceuticals, Inc. March 2009 - February 2010
Boehringer Ingelheim Vetmedica October 2005 - March 2009
DSM Pharma Chemicals August 2002 - September 2005
Restoragen (BioNebraska) May 2001 - July 2002
Oread December 1996 - April 2001
Hauser August 1995 - December 1996
Oread September 1991 - August 1995
Skills
Process Validation, Validation, FDA, Regulatory Affairs, Quality Assurance, V&V, Cleaning Validation, Equipment Qualification, Consent Decree, Compliance Remediation, 21 CFR Part 11, GMP, Quality Management, GLP, Sop, Analytical Chemistry, Technology Transfer, Pharmaceutics, Drug Development, CAPA, Pharmaceutical Industry, Quality Control, GxP, Change Control, SOP
Education
University of Nebraska-Lincoln 1981 — 1986
Bachelor of Science, Chemistry
Cardinal Health Regulatory Sciences January 2015 - Present
Validant March 2011 - December 2014
Aptuit April 2010 - February 2011
Cedarburg Hauser Pharmaceuticals, Inc. March 2009 - February 2010
Boehringer Ingelheim Vetmedica October 2005 - March 2009
DSM Pharma Chemicals August 2002 - September 2005
Restoragen (BioNebraska) May 2001 - July 2002
Oread December 1996 - April 2001
Hauser August 1995 - December 1996
Oread September 1991 - August 1995
Skills
Process Validation, Validation, FDA, Regulatory Affairs, Quality Assurance, V&V, Cleaning Validation, Equipment Qualification, Consent Decree, Compliance Remediation, 21 CFR Part 11, GMP, Quality Management, GLP, Sop, Analytical Chemistry, Technology Transfer, Pharmaceutics, Drug Development, CAPA, Pharmaceutical Industry, Quality Control, GxP, Change Control, SOP
Education
University of Nebraska-Lincoln 1981 — 1986
Bachelor of Science, Chemistry
April Castle April Castle's Cardinal Health Regulatory Sciences Experience September 2015 - Present
Job Document Systems Management, Specialist I Regulatory Submission Ops at Cardinal Health
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences September 2015 - Present
Castle Farms March 2013 - Present
Cardinal Health Regulatory Sciences February 2014 - September 2015
Skills
Customer Service, Microsoft Excel, Microsoft Word, PowerPoint
Education
Tarleton State University 2007 — 2011
Agricultural Services and Development, Agricultural and Extension Education Services
Cardinal Health Regulatory Sciences September 2015 - Present
Castle Farms March 2013 - Present
Cardinal Health Regulatory Sciences February 2014 - September 2015
Skills
Customer Service, Microsoft Excel, Microsoft Word, PowerPoint
Education
Tarleton State University 2007 — 2011
Agricultural Services and Development, Agricultural and Extension Education Services
Melissa L McLauchlin, Ph.D.'s Cardinal Health Regulatory Sciences Experience June 2015 - Present
Job Scientist II
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences June 2015 - Present
Roche Diagnostics April 2008 - February 2011
Arizona State University June 2006 - May 2007
Arizona State University June 2005 - May 2007
Arizona State University August 2002 - May 2007
Arizona State University August 2002 - May 2006
Missouri State Health Lab 2000 - 2001
Skills
Chemistry, Analytical Chemistry, Higher Education, Biotechnology, Leadership, MALDI-MS, SPR, Spectroscopy, UV/Vis, HPLC, Microscopy, R&D, Presentations, Program Development, Team Leadership, Educational Leadership, Program Management, Project Management, Science, Experimental Design, Mentoring, Laboratory, Blackboard, Community Organizing
Education
Arizona State University 2004 — 2007
Ph. D., Chemistry
Arizona State University 2002 — 2004
M.S., Chemistry
University of Central Missouri 1997 — 2001
B.S., Chemistry
Jefferson City High School 1993 — 1997
Cardinal Health Regulatory Sciences June 2015 - Present
Roche Diagnostics April 2008 - February 2011
Arizona State University June 2006 - May 2007
Arizona State University June 2005 - May 2007
Arizona State University August 2002 - May 2007
Arizona State University August 2002 - May 2006
Missouri State Health Lab 2000 - 2001
Skills
Chemistry, Analytical Chemistry, Higher Education, Biotechnology, Leadership, MALDI-MS, SPR, Spectroscopy, UV/Vis, HPLC, Microscopy, R&D, Presentations, Program Development, Team Leadership, Educational Leadership, Program Management, Project Management, Science, Experimental Design, Mentoring, Laboratory, Blackboard, Community Organizing
Education
Arizona State University 2004 — 2007
Ph. D., Chemistry
Arizona State University 2002 — 2004
M.S., Chemistry
University of Central Missouri 1997 — 2001
B.S., Chemistry
Jefferson City High School 1993 — 1997
Brian Cudney's Cardinal Health Regulatory Sciences Experience July 2012 - Present
Job Director, Executive Consulting
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences July 2012 - Present
Nesher Pharmaceuticals (USA) LLC August 2011 - July 2012
KV Pharmaceutical Company March 2007 - August 2011
KV Pharmaceutical Company April 2003 - March 2007
Achillion Pharmaceuticals, Inc December 2001 - May 2002
Bayer August 1998 - December 2001
Dana Corporation January 1996 - January 1998
Delta Faucet January 1995 - January 1996
Skills
GLP, Pharmaceutical Industry, GMP, HPLC, FDA, Validation, Sop, Formulation, Technology Transfer, Drug Delivery, Biopharmaceuticals, Regulatory Submissions, Quality by Design, Clinical Trials, Drug Development, Dissolution, IND, Analytical Chemistry, Computer System..., CAPA, Cleaning Validation, Regulatory Affairs, Chromatography, Generic Programming, 21 CFR Part 11, V&V, R&D, LIMS, Pharmaceutics, Change Control, GxP, Clinical Development, CRO, Regulatory Requirements, USP, Quality System, ANDA, GCP, Contract Manufacturing, Biotechnology, Aseptic Processing, Chemistry, Analytical Method..., Gas Chromatography, SOP, SOP development, UV, UV/Vis
Education
University of Connecticut 2001 — 2003
MBA, Marketing and Technology Emphasis
North Carolina State University 1995 — 1997
Post, Baccalaureate studies in industrial engineering
Ball State University 1991 — 1995
BS, Chemistry
Cardinal Health Regulatory Sciences July 2012 - Present
Nesher Pharmaceuticals (USA) LLC August 2011 - July 2012
KV Pharmaceutical Company March 2007 - August 2011
KV Pharmaceutical Company April 2003 - March 2007
Achillion Pharmaceuticals, Inc December 2001 - May 2002
Bayer August 1998 - December 2001
Dana Corporation January 1996 - January 1998
Delta Faucet January 1995 - January 1996
Skills
GLP, Pharmaceutical Industry, GMP, HPLC, FDA, Validation, Sop, Formulation, Technology Transfer, Drug Delivery, Biopharmaceuticals, Regulatory Submissions, Quality by Design, Clinical Trials, Drug Development, Dissolution, IND, Analytical Chemistry, Computer System..., CAPA, Cleaning Validation, Regulatory Affairs, Chromatography, Generic Programming, 21 CFR Part 11, V&V, R&D, LIMS, Pharmaceutics, Change Control, GxP, Clinical Development, CRO, Regulatory Requirements, USP, Quality System, ANDA, GCP, Contract Manufacturing, Biotechnology, Aseptic Processing, Chemistry, Analytical Method..., Gas Chromatography, SOP, SOP development, UV, UV/Vis
Education
University of Connecticut 2001 — 2003
MBA, Marketing and Technology Emphasis
North Carolina State University 1995 — 1997
Post, Baccalaureate studies in industrial engineering
Ball State University 1991 — 1995
BS, Chemistry
Jenny Cochran's Cardinal Health Regulatory Sciences Experience April 2015 - Present
Job Scientific Consultant at Cardinal Health Regulatory Sciences
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences April 2015 - Present
Queen's Price Chopper Pharmacy July 2012 - June 2014
Cardinal Health 2014 - 2014
Quintiles January 2008 - January 2010
Quintiles March 2007 - January 2008
Skills
Pharmaceutical Research, Business Development, Marketing, Community Pharmacy, Clinical Pharmacy, Pharmacy, Clinical Research, Medicare, Pharmacueticals, Clinical Trials, Medicine, Pharmaceutics, Drug Development, Protocol, Clinical Pharmacology, GCP, CRO, Oncology, Clinical Development, Biotechnology, CTMS, ICH-GCP, Life Sciences, Regulatory Affairs, EDC, Quality Assurance, Diabetes, Pharmaceutical Industry
Education
University of Missouri-Kansas City School of Pharmacy 2009 — 2014
Doctor of Pharmacy (PharmD), Pharmacy
Rockhurst University 2005 — 2006
Master of Business Administration (MBA), Management/International Marketing
Emporia State University 2001 — 2005
Bachelor of Arts (BA), Biochemistry
Cardinal Health Regulatory Sciences April 2015 - Present
Queen's Price Chopper Pharmacy July 2012 - June 2014
Cardinal Health 2014 - 2014
Quintiles January 2008 - January 2010
Quintiles March 2007 - January 2008
Skills
Pharmaceutical Research, Business Development, Marketing, Community Pharmacy, Clinical Pharmacy, Pharmacy, Clinical Research, Medicare, Pharmacueticals, Clinical Trials, Medicine, Pharmaceutics, Drug Development, Protocol, Clinical Pharmacology, GCP, CRO, Oncology, Clinical Development, Biotechnology, CTMS, ICH-GCP, Life Sciences, Regulatory Affairs, EDC, Quality Assurance, Diabetes, Pharmaceutical Industry
Education
University of Missouri-Kansas City School of Pharmacy 2009 — 2014
Doctor of Pharmacy (PharmD), Pharmacy
Rockhurst University 2005 — 2006
Master of Business Administration (MBA), Management/International Marketing
Emporia State University 2001 — 2005
Bachelor of Arts (BA), Biochemistry
Gary Hindman's Cardinal Health Regulatory Sciences Experience 2001 - Present
Job Vice President Pharmaceutical Sciences at Beckloff Associates
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences 2001 - Present
Cardinal Health 2001 - Present
Beckloff Associates/Cardinal Health 2001 - Present
Medicines 360 2013 - 2013
COL LLC 2007 - 2013
Cardinal Health 2006 - 2009
Beckloff Associates 2006 - 2009
Ivy Animal Health 1984 - 2000
Skills
Regulatory Affairs, GMP, FDA, Pharmaceuticals, Validation, Quality Assurance, Strategic Planning, Manufacturing, Pharmaceutical Industry, Biotechnology, Technology Transfer, Sop, GLP, Regulatory Submissions, Drug Development, Life Sciences, CAPA
Education
Louisiana State University 1968 — 1973
Doctor of Philosophy (Ph.D.), Analytical Chemistry
Cardinal Health Regulatory Sciences 2001 - Present
Cardinal Health 2001 - Present
Beckloff Associates/Cardinal Health 2001 - Present
Medicines 360 2013 - 2013
COL LLC 2007 - 2013
Cardinal Health 2006 - 2009
Beckloff Associates 2006 - 2009
Ivy Animal Health 1984 - 2000
Skills
Regulatory Affairs, GMP, FDA, Pharmaceuticals, Validation, Quality Assurance, Strategic Planning, Manufacturing, Pharmaceutical Industry, Biotechnology, Technology Transfer, Sop, GLP, Regulatory Submissions, Drug Development, Life Sciences, CAPA
Education
Louisiana State University 1968 — 1973
Doctor of Philosophy (Ph.D.), Analytical Chemistry
Sara Reddy's Cardinal Health Regulatory Sciences Experience November 2014 - Present
Job Regulatory CMC Scientist
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences November 2014 - Present
Sanofi October 2012 - November 2014
Merck September 2010 - October 2012
Ranbaxy March 2008 - April 2010
Bristol-Myers Squibb January 2006 - December 2007
Perrigo Company January 2005 - October 2005
Schering-Plough Research Institute January 2001 - January 2005
Sigma 1997 - 2000
Penn State University 1995 - 1997
Skills
Detailed Regulatory..., FDA, Analytical Chemistry, ANDA, Drug Development, eCTD, Regulatory Submissions, Regulatory Affairs, GMP, Pharmaceutical Industry, NDA, Technology Transfer, Validation, HPLC, Core WMA, Documentum, PMD, Supply Chain Management, Drug Product Site..., Source of Supply Changes, Drug Product, IND, Regulatory Requirements, CMC, Generic Programming, Dissolution, Quality Assurance, SOP
Education
Université Laval 1992 — 1994
MSc.
Cardinal Health Regulatory Sciences November 2014 - Present
Sanofi October 2012 - November 2014
Merck September 2010 - October 2012
Ranbaxy March 2008 - April 2010
Bristol-Myers Squibb January 2006 - December 2007
Perrigo Company January 2005 - October 2005
Schering-Plough Research Institute January 2001 - January 2005
Sigma 1997 - 2000
Penn State University 1995 - 1997
Skills
Detailed Regulatory..., FDA, Analytical Chemistry, ANDA, Drug Development, eCTD, Regulatory Submissions, Regulatory Affairs, GMP, Pharmaceutical Industry, NDA, Technology Transfer, Validation, HPLC, Core WMA, Documentum, PMD, Supply Chain Management, Drug Product Site..., Source of Supply Changes, Drug Product, IND, Regulatory Requirements, CMC, Generic Programming, Dissolution, Quality Assurance, SOP
Education
Université Laval 1992 — 1994
MSc.
Jacqueline Meffen's Cardinal Health Regulatory Sciences Experience 2015 - Present
Job Consultant, CMC at Cardinal Health
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences 2015 - Present
Pharma Tech Industries November 2013 - March 2015
Pharma Tech Industries February 2013 - November 2013
Legacy Pharmaceutical Packaging October 2012 - February 2013
KV Pharmaceutical March 2011 - September 2012
KV Pharmaceutical December 2008 - March 2011
KV Pharmaceutical August 2006 - December 2008
Abbott Laboratories February 2000 - July 2006
Skills
CAPA, Quality System, Pharmaceutical Industry, GMP, Quality Assurance, Leadership, FDA, Auditing, Change Control, Regulatory Affairs, Sop, Product Development, Manufacturing, Software Documentation, Document Management, 21 CFR Part 11, Validation, Management, LIMS, Computer System..., Quality Management, GxP, V&V, Quality Auditing, GLP, Process Simulation, Regulatory Submissions, Cross-functional Team..., Root Cause Analysis, Continuous Improvement, Biopharmaceuticals, Technology Transfer, Quality Control, R&D, Regulatory Requirements, Lean Manufacturing, GCP, Trackwise, Pharmaceutics, Biotechnology, Cleaning Validation, Aseptic Processing, FDA GMP, ISO 13485, Design Control, Medical Devices, Supplier Quality, Six Sigma, ISO, GAMP
Education
Illinois College 1995 — 1999
BS, Biology/Pre-Vet
Glenbard North High School
Cardinal Health Regulatory Sciences 2015 - Present
Pharma Tech Industries November 2013 - March 2015
Pharma Tech Industries February 2013 - November 2013
Legacy Pharmaceutical Packaging October 2012 - February 2013
KV Pharmaceutical March 2011 - September 2012
KV Pharmaceutical December 2008 - March 2011
KV Pharmaceutical August 2006 - December 2008
Abbott Laboratories February 2000 - July 2006
Skills
CAPA, Quality System, Pharmaceutical Industry, GMP, Quality Assurance, Leadership, FDA, Auditing, Change Control, Regulatory Affairs, Sop, Product Development, Manufacturing, Software Documentation, Document Management, 21 CFR Part 11, Validation, Management, LIMS, Computer System..., Quality Management, GxP, V&V, Quality Auditing, GLP, Process Simulation, Regulatory Submissions, Cross-functional Team..., Root Cause Analysis, Continuous Improvement, Biopharmaceuticals, Technology Transfer, Quality Control, R&D, Regulatory Requirements, Lean Manufacturing, GCP, Trackwise, Pharmaceutics, Biotechnology, Cleaning Validation, Aseptic Processing, FDA GMP, ISO 13485, Design Control, Medical Devices, Supplier Quality, Six Sigma, ISO, GAMP
Education
Illinois College 1995 — 1999
BS, Biology/Pre-Vet
Glenbard North High School
Miguel A. de Soto-Perera's Cardinal Health Regulatory Sciences Experience February 2015 - Present
Job Director at Cardinal Health Regulatory Sciences
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences February 2015 - Present
Cardinal Health Regulatory Sciences June 2014 - February 2015
Beckloff Associates, Inc. July 2007 - June 2010
Beckloff associates, Inc. September 1995 - July 2007
Marion Merrell Dow, Inc. August 1994 - April 1995
Marion Merrell Dow, Inc. August 1992 - August 1994
Merrell Dow Pharmaceuticals June 1984 - August 1992
The Dow Chemical Company November 1979 - June 1984
Skills
Regulatory Affairs, FDA, Drug Development, Pharmaceutical Industry, Clinical Development, GLP, IND, Biopharmaceuticals, SOP, GCP, GMP, Biotechnology
Education
University of Massachusetts, Amherst 1976 — 1979
Doctor of Philosophy (Ph.D.), Electroanalytical Chemistry
University of Massachusetts, Amherst 1972 — 1976
Master's Degree, Analytical Chemistry
Universidad de Puerto Rico 1968 — 1972
Bachelor's Degree, Chemistry
Colegio San Antonio, Rio Piedras, Puerto Rico 1963 — 1968
High School
Henry H. Filer Junior High School, Hialeah, Florida 1962 — 1963
Escuelas Pias, Havana, Cuba 1956 — 1962
Cardinal Health Regulatory Sciences February 2015 - Present
Cardinal Health Regulatory Sciences June 2014 - February 2015
Beckloff Associates, Inc. July 2007 - June 2010
Beckloff associates, Inc. September 1995 - July 2007
Marion Merrell Dow, Inc. August 1994 - April 1995
Marion Merrell Dow, Inc. August 1992 - August 1994
Merrell Dow Pharmaceuticals June 1984 - August 1992
The Dow Chemical Company November 1979 - June 1984
Skills
Regulatory Affairs, FDA, Drug Development, Pharmaceutical Industry, Clinical Development, GLP, IND, Biopharmaceuticals, SOP, GCP, GMP, Biotechnology
Education
University of Massachusetts, Amherst 1976 — 1979
Doctor of Philosophy (Ph.D.), Electroanalytical Chemistry
University of Massachusetts, Amherst 1972 — 1976
Master's Degree, Analytical Chemistry
Universidad de Puerto Rico 1968 — 1972
Bachelor's Degree, Chemistry
Colegio San Antonio, Rio Piedras, Puerto Rico 1963 — 1968
High School
Henry H. Filer Junior High School, Hialeah, Florida 1962 — 1963
Escuelas Pias, Havana, Cuba 1956 — 1962
Kristene Castle's Cardinal Health Regulatory Sciences Experience 2006 - Present
Job Director, Executive Consultant, at Cardinal Health Regulatory Sciences
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences 2006 - Present
Aptuit 2004 - 2006
Quintiles 1998 - 2004
Hoechst Marion Roussel, Inc and predecessor companies 1988 - 1998
Skills
GLP, Toxicology, Sop, Regulatory Affairs, Quality Assurance, FDA, CRO, GMP, Software Documentation, Drug Development, Regulatory Submissions, Pharmaceutical Industry
Education
Indiana Wesleyan University 1992 — 1994
B.S., Business
Truman State University 1981 — 1983
A.S., Veterinary Technology
Cardinal Health Regulatory Sciences 2006 - Present
Aptuit 2004 - 2006
Quintiles 1998 - 2004
Hoechst Marion Roussel, Inc and predecessor companies 1988 - 1998
Skills
GLP, Toxicology, Sop, Regulatory Affairs, Quality Assurance, FDA, CRO, GMP, Software Documentation, Drug Development, Regulatory Submissions, Pharmaceutical Industry
Education
Indiana Wesleyan University 1992 — 1994
B.S., Business
Truman State University 1981 — 1983
A.S., Veterinary Technology
Felicia Del Buono, MS's Cardinal Health Regulatory Sciences Experience July 2015 - Present
Job Regulatory Medical Writer at Cardinal Health Regulatory Sciences
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences July 2015 - Present
Elverson Medical Writing, LLC July 2012 - Present
Precision Research, Inc. 2013 - 2015
GSK 2009 - 2012
On Assignment 2007 - 2008
Yoh Scientific Inc 2005 - 2005
Yoh Scientific Inc 2003 - 2004
Aerotek 2002 - 2003
GlaxoSmithKline Biologicals August 1986 - November 2002
SmithKline Beecham August 1986 - August 1995
Skills
Medical Writing, Vaccines, Oncology, Pharmaceutical Industry, Clinical Trials, Infectious Diseases, Clinical Development, Clinical Research, FDA, Lifesciences, Biotechnology, Regulatory Submissions, CRO, Immunology, Drug Development, Life Sciences
Education
University of the Sciences in Philadelphia 2008 — 2012
Master's Degree, Biomedical Writing
University of the Sciences in Philadelphia 1976 — 1980
BS MT (ASCP), Medical Technology / Clinical Laboratory Science
Hood College 1975 — 1976
Medical Technology
Plymouth-Whitemarsh High School 1972 — 1975
Cardinal Health Regulatory Sciences July 2015 - Present
Elverson Medical Writing, LLC July 2012 - Present
Precision Research, Inc. 2013 - 2015
GSK 2009 - 2012
On Assignment 2007 - 2008
Yoh Scientific Inc 2005 - 2005
Yoh Scientific Inc 2003 - 2004
Aerotek 2002 - 2003
GlaxoSmithKline Biologicals August 1986 - November 2002
SmithKline Beecham August 1986 - August 1995
Skills
Medical Writing, Vaccines, Oncology, Pharmaceutical Industry, Clinical Trials, Infectious Diseases, Clinical Development, Clinical Research, FDA, Lifesciences, Biotechnology, Regulatory Submissions, CRO, Immunology, Drug Development, Life Sciences
Education
University of the Sciences in Philadelphia 2008 — 2012
Master's Degree, Biomedical Writing
University of the Sciences in Philadelphia 1976 — 1980
BS MT (ASCP), Medical Technology / Clinical Laboratory Science
Hood College 1975 — 1976
Medical Technology
Plymouth-Whitemarsh High School 1972 — 1975
Shara Ambrosecchia's Cardinal Health Regulatory Sciences Experience November 2014 - Present
Job Senior Consultant, Regulatory Affairs at Cardinal Health Regulatory Sciences
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences November 2014 - Present
G&W Laboratories November 2012 - Present
Perrigo April 2009 - November 2012
KV Pharmaceutical March 2007 - April 2009
Covidien January 2004 - March 2007
Skills
Regulatory Affairs, Pharmaceuticals, Compliance, Generics, FDA, Regulatory Submissions, Sop, GMP, Regulations, Change Control, Generic Programming, 21 CFR Part 11, Technology Transfer, Regulatory Requirements, eCTD, IND, Pharmaceutical Industry, GxP, CAPA, Validation, ANDA, CRO, Oncology
Education
Temple University 2008 — 2010
MS, Regulatory Affairs/Quality Affairs
University of Missouri-Saint Louis 1995 — 2000
BS, Biology/Chemistry
Cardinal Health Regulatory Sciences November 2014 - Present
G&W Laboratories November 2012 - Present
Perrigo April 2009 - November 2012
KV Pharmaceutical March 2007 - April 2009
Covidien January 2004 - March 2007
Skills
Regulatory Affairs, Pharmaceuticals, Compliance, Generics, FDA, Regulatory Submissions, Sop, GMP, Regulations, Change Control, Generic Programming, 21 CFR Part 11, Technology Transfer, Regulatory Requirements, eCTD, IND, Pharmaceutical Industry, GxP, CAPA, Validation, ANDA, CRO, Oncology
Education
Temple University 2008 — 2010
MS, Regulatory Affairs/Quality Affairs
University of Missouri-Saint Louis 1995 — 2000
BS, Biology/Chemistry
Rose Azzaro-Bass's Cardinal Health Regulatory Sciences Experience September 2014 - Present
Job Senior Consultant at Cardinal Health
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences September 2014 - Present
Acceleration Laboratory Services, Inc. March 2004 - September 2014
Diversity Language School 1998 - 2010
Quintiles 1998 - 2004
Marion Laboratories / Marion Merrell Dow 1986 - 1998
Skills
Quality Assurance, FDA, GMP, Validation, Sop, Pharmaceutical Industry, GLP, Quality System, Technology Transfer, Biotechnology, CRO, Regulatory Affairs, Analytical Chemistry, HPLC, Change Control
Education
University of Missouri-Columbia 1982 — 1986
BS, Medical Technology
Cardinal Health Regulatory Sciences September 2014 - Present
Acceleration Laboratory Services, Inc. March 2004 - September 2014
Diversity Language School 1998 - 2010
Quintiles 1998 - 2004
Marion Laboratories / Marion Merrell Dow 1986 - 1998
Skills
Quality Assurance, FDA, GMP, Validation, Sop, Pharmaceutical Industry, GLP, Quality System, Technology Transfer, Biotechnology, CRO, Regulatory Affairs, Analytical Chemistry, HPLC, Change Control
Education
University of Missouri-Columbia 1982 — 1986
BS, Medical Technology
Heather K Reimer's Cardinal Health Regulatory Sciences Experience March 2015 - Present
Job Transforming Regulatory Sciences | Business Development
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences March 2015 - Present
Cmed Clinical Services November 2013 - February 2015
ERT December 2012 - November 2013
ERT June 2010 - December 2012
CareFusion June 2009 - June 2010
Cardinal Health June 2008 - June 2009
Skills
Business Development, Account Management, Contract Negotiation, Strategic Partnerships, Cross-functional Team..., Pharmaceutical Industry, Biotechnology, Medical Devices, Clinical Trials, Competitive Analysis, Lifesciences, New Business Development, Oncology, Sales Operations, CRO, Clinical Development, Cardiology, Healthcare, Neurology, Clinical Research, Selling, GCP, EDC, CTMS, Clinical Data Management, Pharmaceutics, Therapeutic Areas, Clinical Monitoring, Sales, Regulatory Requirements
Education
Kennesaw State University - Michael J. Coles College of Business 2000 — 2004
BBA, Business Administration
University of Alabama 1998 — 2000
Business Administration
Cardinal Health Regulatory Sciences March 2015 - Present
Cmed Clinical Services November 2013 - February 2015
ERT December 2012 - November 2013
ERT June 2010 - December 2012
CareFusion June 2009 - June 2010
Cardinal Health June 2008 - June 2009
Skills
Business Development, Account Management, Contract Negotiation, Strategic Partnerships, Cross-functional Team..., Pharmaceutical Industry, Biotechnology, Medical Devices, Clinical Trials, Competitive Analysis, Lifesciences, New Business Development, Oncology, Sales Operations, CRO, Clinical Development, Cardiology, Healthcare, Neurology, Clinical Research, Selling, GCP, EDC, CTMS, Clinical Data Management, Pharmaceutics, Therapeutic Areas, Clinical Monitoring, Sales, Regulatory Requirements
Education
Kennesaw State University - Michael J. Coles College of Business 2000 — 2004
BBA, Business Administration
University of Alabama 1998 — 2000
Business Administration
Anthony Yannotta's Cardinal Health Regulatory Sciences Experience September 2007 - Present
Job Specialist II, Regulatory Submission Operations at Cardinal Health Regulatory Sciences
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences September 2007 - Present
Skills
Regulatory Submissions, FDA, Regulatory Affairs, GCP, Pharmaceutical Industry, Regulatory Requirements, Quality Assurance, Sop, Drug Development, Validation, Quality System, Microsoft Office, 21 CFR Part 11, Computer System...
Education
University of Kansas 2001 — 2006
Bachelor's degree, English
Cardinal Health Regulatory Sciences September 2007 - Present
Skills
Regulatory Submissions, FDA, Regulatory Affairs, GCP, Pharmaceutical Industry, Regulatory Requirements, Quality Assurance, Sop, Drug Development, Validation, Quality System, Microsoft Office, 21 CFR Part 11, Computer System...
Education
University of Kansas 2001 — 2006
Bachelor's degree, English
Gary Schmitt's Cardinal Health Regulatory Sciences Experience August 2015 - Present
Job Senior Scientist CMC at Cardinal Health Regulatory Sciences
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences August 2015 - Present
Acceleration Laboratory Services, Inc. November 2009 - July 2015
Acceleration, L.L.C. August 2003 - October 2009
Quintiles, Inc. April 2002 - January 2004
Quintiles, Inc. April 2001 - April 2002
Quintiles, Inc. January 1999 - April 2001
Hoechst Marion Roussel Inc. 1990 - December 1998
Marion Laboratories, Inc. August 1989 - 1990
Baxter Healthcare July 1988 - July 1989
PPG Industries August 1985 - July 1988
Skills
Gas Chromatography, GLP, HPLC, Pharmaceutical Industry, Analytical Chemistry, Size Exclusion, Chromatography, Drug Development, Chemistry, Laboratory, SOP, Technology Transfer, Validation, Pharmaceutics, GMP
Education
University of Iowa 1981 — 1985
Ph.D., Analytical Chemistry
University of Northern Iowa 1977 — 1981
B.A., Chemistry
Cardinal Health Regulatory Sciences August 2015 - Present
Acceleration Laboratory Services, Inc. November 2009 - July 2015
Acceleration, L.L.C. August 2003 - October 2009
Quintiles, Inc. April 2002 - January 2004
Quintiles, Inc. April 2001 - April 2002
Quintiles, Inc. January 1999 - April 2001
Hoechst Marion Roussel Inc. 1990 - December 1998
Marion Laboratories, Inc. August 1989 - 1990
Baxter Healthcare July 1988 - July 1989
PPG Industries August 1985 - July 1988
Skills
Gas Chromatography, GLP, HPLC, Pharmaceutical Industry, Analytical Chemistry, Size Exclusion, Chromatography, Drug Development, Chemistry, Laboratory, SOP, Technology Transfer, Validation, Pharmaceutics, GMP
Education
University of Iowa 1981 — 1985
Ph.D., Analytical Chemistry
University of Northern Iowa 1977 — 1981
B.A., Chemistry
Faith Peterman's Cardinal Health Regulatory Sciences Experience March 2015 - Present
Job Scientist III/Medical Writer
Industry Research
Experience
Cardinal Health Regulatory Sciences March 2015 - Present
Balderston Chiropractic September 2012 - March 2015
PRA International April 2011 - March 2012
PRA International February 2011 - April 2011
Skills
Clinical Trials, Chiropractic, CRO, Clinical Research, Rehabilitation, Flexion Distraction, GCP, Nutritional Counseling, CTMS, Clinical Monitoring, Neurology, ICH-GCP, Clinical Data Management, Biotechnology, Life Sciences, EDC, Oncology, Patient Recruitment, Lifesciences, Activator Methods..., Nutrtiotion Counseling, Diversified Technique, Flexion/Distraction..., Medical Writing, Regulatory Submissions
Education
Cleveland Chiropractic College 1996 — 2000
Doctor of Chiropractic, Chiropractic
Cleveland Chiropractic College 1996 — 2000
Bachelor's degree, Human Biology
Cardinal Health Regulatory Sciences March 2015 - Present
Balderston Chiropractic September 2012 - March 2015
PRA International April 2011 - March 2012
PRA International February 2011 - April 2011
Skills
Clinical Trials, Chiropractic, CRO, Clinical Research, Rehabilitation, Flexion Distraction, GCP, Nutritional Counseling, CTMS, Clinical Monitoring, Neurology, ICH-GCP, Clinical Data Management, Biotechnology, Life Sciences, EDC, Oncology, Patient Recruitment, Lifesciences, Activator Methods..., Nutrtiotion Counseling, Diversified Technique, Flexion/Distraction..., Medical Writing, Regulatory Submissions
Education
Cleveland Chiropractic College 1996 — 2000
Doctor of Chiropractic, Chiropractic
Cleveland Chiropractic College 1996 — 2000
Bachelor's degree, Human Biology
Todd Phillips, PharmD, RAC's Cardinal Health Regulatory Sciences Experience June 2014 - Present
Job Director, Executive Consultant at Cardinal Health Regulatory Sciences
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences June 2014 - Present
Beckloff Associates (a Cardinal Health company) March 2011 - June 2014
Food and Drug Administration January 2009 - March 2011
Quintiles January 2008 - December 2008
Quintiles December 2006 - December 2007
Quintiles July 2005 - December 2006
Novartis Pharmaceuticals/Rutgers University Fellowship (Clnical Research and Marketing) June 2003 - June 2005
Skills
Regulatory Affairs, Project Management, Clinical Development, Clinical Pharmacology, Clinical Trials, Pharmaceutical Industry, Oncology, Regulatory Submissions, FDA, Clinical Research, SOP, Biotechnology
Education
University of Missouri-Kansas City 1998 — 2003
Pharm.D., Pharmacy
Cardinal Health Regulatory Sciences June 2014 - Present
Beckloff Associates (a Cardinal Health company) March 2011 - June 2014
Food and Drug Administration January 2009 - March 2011
Quintiles January 2008 - December 2008
Quintiles December 2006 - December 2007
Quintiles July 2005 - December 2006
Novartis Pharmaceuticals/Rutgers University Fellowship (Clnical Research and Marketing) June 2003 - June 2005
Skills
Regulatory Affairs, Project Management, Clinical Development, Clinical Pharmacology, Clinical Trials, Pharmaceutical Industry, Oncology, Regulatory Submissions, FDA, Clinical Research, SOP, Biotechnology
Education
University of Missouri-Kansas City 1998 — 2003
Pharm.D., Pharmacy
Rebecca Wharton's Cardinal Health Regulatory Sciences Experience December 2001 - Present
Job Principal Scientist, Regulatory Affairs & Product Development, Cardinal Health Regulatory Sciences
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences December 2001 - Present
Metropolitan Community Colleges (Missouri) and Rockhurst University January 1997 - December 2001
University of Kansas Medical Center September 1994 - December 1996
Skills
FDA, Drug Development, Immunology, Microbiology, Validation
Education
University of Missouri-Kansas City 1989 — 1994
Ph.D., Biochemistry
University of Central Missouri 1984 — 1988
BS, Medical Technology
Cardinal Health Regulatory Sciences December 2001 - Present
Metropolitan Community Colleges (Missouri) and Rockhurst University January 1997 - December 2001
University of Kansas Medical Center September 1994 - December 1996
Skills
FDA, Drug Development, Immunology, Microbiology, Validation
Education
University of Missouri-Kansas City 1989 — 1994
Ph.D., Biochemistry
University of Central Missouri 1984 — 1988
BS, Medical Technology
Brenda Schlenk's Cardinal Health Regulatory Sciences Experience 1996 - Present
Job Principal Scientist, Medical Writing
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences 1996 - Present
Skills
Medical Writing, Pharmaceutical Industry, Regulatory Submissions
Education
University of Kansas 1990 — 1996
Bachelor of Science (BS), Pharmacy
Cardinal Health Regulatory Sciences 1996 - Present
Skills
Medical Writing, Pharmaceutical Industry, Regulatory Submissions
Education
University of Kansas 1990 — 1996
Bachelor of Science (BS), Pharmacy