RRD International, LLC
Industry: Company
DescriptionFounded: 2002 Subsidiary: ClearPath Development CompanyFeedbackDisclaimer Claim this knowledge panel Knowledge ResultSee outside Moved, closed, or was never hereReportRRD International, LLCWebsiteDirections Saved (0) Saved Save Pharmaceutical company in Derwood, Maryland Address: 7361 Calhoun Pl # 510, Derwood, MD 20855 Phone: (301) 762-6100Hours: : Website: Place name: : : : Category: : : Website: http://www.rrdintl.com/ Category: Pharmaceutical company Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo.Add missing informationAdd business hours Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of RRD International, LLC Posting publicly on the Web Write a review Reviews Be the first to review
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RRD International, LLC Employees
Employee
Years
Job
Industry
Jen DiGiacinto Jen DiGiacinto's RRD International, LLC Experience August 2013 - Present
Job Senior Clinical Pharmacologist
Industry Pharmaceuticals
Experience
RRD International, LLC August 2013 - Present
RRD International, LLC August 2013 - Present
Salamandra LLC June 2007 - August 2013
FDA July 2000 - June 2007
FDA July 2000 - June 2007
UIC COM-Peoria 1998 - 2000
Skills
Clinical Pharmacology..., BE, DDI, FIH, SD, MD,..., Strategic and Technical..., Clinical Pharmacology, Drug Development, Pharmaceutical Industry, IND, Clinical Development, Ethnobridging Studies, Pharmacogenomics, PK/PD, Regulatory Affairs, NDA, Orphan Drugs, New Business Development, Population Studies, Clinical Trials, Regulatory Submissions, Protocol, Pharmacodynamics, Medical Writing, Oncology, Pharmacology, Pharmacovigilance, Drug Safety, GCP, Regula, GMP, Clinical Study Design, Clinical Research, Bioanalysis, Biopharmaceuticals, GLP, Pharmaceutics, Infectious Diseases, CTMS, Regulatory Requirements, Vaccines, In vitro CYP450/UGT &..., Drug Metabolism, In Vitro, Drug Discovery, Sop, Biotechnology, Lifesciences, CRO, FDA, EDC, SOP, Life Sciences
Education
University of Illinois College of Medicine 1998 — 2000
Completion of 2 year Fellowship, Clinical Pharmacology
University of Nebraska Medical Center 1993 — 1997
Pharm.D., Pharmacy
RRD International, LLC August 2013 - Present
RRD International, LLC August 2013 - Present
Salamandra LLC June 2007 - August 2013
FDA July 2000 - June 2007
FDA July 2000 - June 2007
UIC COM-Peoria 1998 - 2000
Skills
Clinical Pharmacology..., BE, DDI, FIH, SD, MD,..., Strategic and Technical..., Clinical Pharmacology, Drug Development, Pharmaceutical Industry, IND, Clinical Development, Ethnobridging Studies, Pharmacogenomics, PK/PD, Regulatory Affairs, NDA, Orphan Drugs, New Business Development, Population Studies, Clinical Trials, Regulatory Submissions, Protocol, Pharmacodynamics, Medical Writing, Oncology, Pharmacology, Pharmacovigilance, Drug Safety, GCP, Regula, GMP, Clinical Study Design, Clinical Research, Bioanalysis, Biopharmaceuticals, GLP, Pharmaceutics, Infectious Diseases, CTMS, Regulatory Requirements, Vaccines, In vitro CYP450/UGT &..., Drug Metabolism, In Vitro, Drug Discovery, Sop, Biotechnology, Lifesciences, CRO, FDA, EDC, SOP, Life Sciences
Education
University of Illinois College of Medicine 1998 — 2000
Completion of 2 year Fellowship, Clinical Pharmacology
University of Nebraska Medical Center 1993 — 1997
Pharm.D., Pharmacy
Mallory Finn Mallory Finn's RRD International, LLC Experience January 2006 - June 2006
Job Staff Attorney at Project HEAL
Industry
Experience
Project HEAL at Kennedy Krieger Institute December 2014 - Present
Project HEAL August 2014 - December 2014
Maryland Center for Developmental Disabilities August 2013 - December 2013
Project HEAL May 2013 - August 2013
University of Maryland Law Clinical Office January 2013 - May 2013
The Norman Law Firm May 2012 - August 2012
Mango's May 2010 - August 2012
Circuit Court for Montgomery County December 2010 - February 2011
KAI Research, Inc June 2007 - August 2007
RRD International, LLC January 2006 - June 2006
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Research, Windows, Outlook, Photoshop, Civil Litigation
Education
University of Maryland School of Law 2011 — 2014
University of Delaware 2006 — 2010
Bachelor of Arts (B.A.), Sociology
Project HEAL at Kennedy Krieger Institute December 2014 - Present
Project HEAL August 2014 - December 2014
Maryland Center for Developmental Disabilities August 2013 - December 2013
Project HEAL May 2013 - August 2013
University of Maryland Law Clinical Office January 2013 - May 2013
The Norman Law Firm May 2012 - August 2012
Mango's May 2010 - August 2012
Circuit Court for Montgomery County December 2010 - February 2011
KAI Research, Inc June 2007 - August 2007
RRD International, LLC January 2006 - June 2006
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Research, Windows, Outlook, Photoshop, Civil Litigation
Education
University of Maryland School of Law 2011 — 2014
University of Delaware 2006 — 2010
Bachelor of Arts (B.A.), Sociology
Alexis Reisin Miller Alexis Reisin Miller's RRD International, LLC Experience August 2004 - February 2006
Job Senior Director, Global Regulatory Policy and Intelligence at Eisai
Industry Law Practice
Experience
Eisai June 2014 - Present
Morgan, Lewis & Bockius LLP September 2011 - June 2014
FDA July 2010 - August 2011
Morgan, Lewis & Bockius LLP July 2006 - July 2010
Keller and Heckman LLP February 2006 - July 2006
RRD International, LLC August 2004 - February 2006
Goodell, DeVries, Leech, and Dann, LLP May 2002 - June 2004
Skills
Food, Drug, and..., FTC Consumer Protection..., FDA Law, CPSC Counseling, FDA, FTC, CPSC, Consumer Law, Matters, Pharmaceutical Industry, Regulatory Affairs, Litigation, Health Law, Commercial Litigation, Healthcare, Legal Writing, Licensing, Corporate Law, Corporate Governance, Administrative Law, Privacy Law, Legal Advice, Civil Litigation
Education
The Catholic University of America, Columbus School of Law 2000 — 2003
JD
New York University 1996 — 1999
BA, International Business, International Relations
Eisai June 2014 - Present
Morgan, Lewis & Bockius LLP September 2011 - June 2014
FDA July 2010 - August 2011
Morgan, Lewis & Bockius LLP July 2006 - July 2010
Keller and Heckman LLP February 2006 - July 2006
RRD International, LLC August 2004 - February 2006
Goodell, DeVries, Leech, and Dann, LLP May 2002 - June 2004
Skills
Food, Drug, and..., FTC Consumer Protection..., FDA Law, CPSC Counseling, FDA, FTC, CPSC, Consumer Law, Matters, Pharmaceutical Industry, Regulatory Affairs, Litigation, Health Law, Commercial Litigation, Healthcare, Legal Writing, Licensing, Corporate Law, Corporate Governance, Administrative Law, Privacy Law, Legal Advice, Civil Litigation
Education
The Catholic University of America, Columbus School of Law 2000 — 2003
JD
New York University 1996 — 1999
BA, International Business, International Relations
Dan Salins Dan Salins's RRD International, LLC Experience March 2004 - Present
Job Senior Director, Finance at RRD International, LLC
Industry Biotechnology
Experience
RRD International, LLC March 2004 - Present
Various March 2001 - March 2004
Genesis Engineering Company, LLC July 1996 - March 2001
Meisel and Cohen Properties September 1992 - July 1996
Sol Salins, Inc. August 1990 - September 1992
US Airways August 1988 - August 1990
US Airways June 1986 - August 1988
Regardie Brooks & Lewis September 1984 - June 1986
Skills
Deltek, Government Contracting..., Cognos, PeopleSoft, Due Diligence, Fixed Assets, GAAP, QuickBooks, Costpoint, General Ledger, Financial Statements, Revenue Recognition, Accounting, Management, Strategic Planning, Internal Audit, Finance, Financial Reporting, Pharmaceutical Industry, Process Improvement, Executive Management, Financial Modeling
Education
University of Maryland College Park 1982 — 1984
BS, Accounting
Robert E. Peary High School 1977 — 1980
RRD International, LLC March 2004 - Present
Various March 2001 - March 2004
Genesis Engineering Company, LLC July 1996 - March 2001
Meisel and Cohen Properties September 1992 - July 1996
Sol Salins, Inc. August 1990 - September 1992
US Airways August 1988 - August 1990
US Airways June 1986 - August 1988
Regardie Brooks & Lewis September 1984 - June 1986
Skills
Deltek, Government Contracting..., Cognos, PeopleSoft, Due Diligence, Fixed Assets, GAAP, QuickBooks, Costpoint, General Ledger, Financial Statements, Revenue Recognition, Accounting, Management, Strategic Planning, Internal Audit, Finance, Financial Reporting, Pharmaceutical Industry, Process Improvement, Executive Management, Financial Modeling
Education
University of Maryland College Park 1982 — 1984
BS, Accounting
Robert E. Peary High School 1977 — 1980
Nadine Tigney Nadine Tigney's RRD International, LLC Experience October 2014 - January 2015
Job Director, Clinical Contracts & Budgeting at Novavax
Industry Biotechnology
Experience
Novavax January 2015 - Present
RRD International, LLC October 2014 - January 2015
Lung Biotechnology Inc. (previously known as Lung LLC and a subsidiary of United Therapeutics) May 2011 - October 2014
Intercell USA, Inc November 2009 - April 2011
GenVec May 2006 - October 2009
GenVec June 2005 - May 2006
American Immigration Reform August 2003 - May 2005
Osprey Ship Management, Inc. (now APL Maritime, Inc.) August 2001 - August 2003
Skills
Contract Management, Accounting, Budgeting, Invoicing, Spreadsheets, Biotechnology, SOX, Microsoft Office, Budgets, Sarbanes-Oxley, CRO, Sarbanes-Oxley Act, Regulatory Affairs, Internal Audit, Accounts Payable, Project Planning, Software Documentation, Regulatory Submissions, FDA, Sop, CTMS, Clinical Trials, Data Analysis, Clinical Development, Microsoft Excel, Biopharmaceuticals, Clinical Research, Pharmaceutical Industry, GCP, Payroll, Management, EDC, Infectious Diseases, Life Sciences
Education
University of Maryland University College 2002 — 2006
Master of Science, Management; Accounting
University of Maryland University College
Bachelor of Science, Business Management
École secondaire Corsier
Novavax January 2015 - Present
RRD International, LLC October 2014 - January 2015
Lung Biotechnology Inc. (previously known as Lung LLC and a subsidiary of United Therapeutics) May 2011 - October 2014
Intercell USA, Inc November 2009 - April 2011
GenVec May 2006 - October 2009
GenVec June 2005 - May 2006
American Immigration Reform August 2003 - May 2005
Osprey Ship Management, Inc. (now APL Maritime, Inc.) August 2001 - August 2003
Skills
Contract Management, Accounting, Budgeting, Invoicing, Spreadsheets, Biotechnology, SOX, Microsoft Office, Budgets, Sarbanes-Oxley, CRO, Sarbanes-Oxley Act, Regulatory Affairs, Internal Audit, Accounts Payable, Project Planning, Software Documentation, Regulatory Submissions, FDA, Sop, CTMS, Clinical Trials, Data Analysis, Clinical Development, Microsoft Excel, Biopharmaceuticals, Clinical Research, Pharmaceutical Industry, GCP, Payroll, Management, EDC, Infectious Diseases, Life Sciences
Education
University of Maryland University College 2002 — 2006
Master of Science, Management; Accounting
University of Maryland University College
Bachelor of Science, Business Management
École secondaire Corsier
Christina Perry Christina Perry's RRD International, LLC Experience January 2005 - May 2006
Job Clinical Research Scientist/Project Lead at Vanda Pharmaceuticals
Industry Biotechnology
Experience
Vanda Pharmaceuticals April 2011 - Present
Intercell AG, Intercell USA May 2009 - April 2011
GenVec, Inc. May 2006 - January 2009
RRD International, LLC January 2005 - May 2006
University of North Carolina December 2003 - January 2005
Skills
Clinical Trials, CRO, Clinical Monitoring, Oncology, Clinical Research, Sop, FDA, Protocol, Data Management, IND, Training, Management, Clinical Study Design, Research, Clinical Development, Biotechnology, Budgets, CTMS, Biologics, GCP, SOP
Education
The George Washington University - School of Business 2013 — 2014
Master of Business Administration (MBA)
University of North Carolina at Chapel Hill 1999 — 2003
Bachelor of Arts, Exercise and Sport Science
Vanda Pharmaceuticals April 2011 - Present
Intercell AG, Intercell USA May 2009 - April 2011
GenVec, Inc. May 2006 - January 2009
RRD International, LLC January 2005 - May 2006
University of North Carolina December 2003 - January 2005
Skills
Clinical Trials, CRO, Clinical Monitoring, Oncology, Clinical Research, Sop, FDA, Protocol, Data Management, IND, Training, Management, Clinical Study Design, Research, Clinical Development, Biotechnology, Budgets, CTMS, Biologics, GCP, SOP
Education
The George Washington University - School of Business 2013 — 2014
Master of Business Administration (MBA)
University of North Carolina at Chapel Hill 1999 — 2003
Bachelor of Arts, Exercise and Sport Science
Kimberly Lager, MS, RAC Kimberly Lager, MS, RAC's RRD International, LLC Experience 2010 - Present
Job Senior Regulatory Affairs Specialist at RRD International, LLC
Industry Pharmaceuticals
Experience
RRD International, LLC 2010 - Present
Novavax, Inc June 2008 - August 2010
Johns Hopkins University August 2006 - May 2008
Cognate BioServices April 2006 - July 2006
Becton Dickinson June 2005 - April 2006
Bioserve Biotechnologies, Ltd June 2004 - February 2005
Skills
GMP, Regulatory Affairs, Drug Development, Regulatory Strategy, Regulatory Submissions, Protocol Writing, ICH-GCP, Pharmaceutical Law, Vaccines, Clinical Research, FDA, Clinical Development, Strategy, Quality System, Biotechnology, Biopharmaceuticals, IND, V&V
Education
The Johns Hopkins University 2007 — 2010
Masters, Bioscience Regulatory Affairs
College of Notre Dame of Maryland 2001 — 2005
BA, Biology, Chemistry
RRD International, LLC 2010 - Present
Novavax, Inc June 2008 - August 2010
Johns Hopkins University August 2006 - May 2008
Cognate BioServices April 2006 - July 2006
Becton Dickinson June 2005 - April 2006
Bioserve Biotechnologies, Ltd June 2004 - February 2005
Skills
GMP, Regulatory Affairs, Drug Development, Regulatory Strategy, Regulatory Submissions, Protocol Writing, ICH-GCP, Pharmaceutical Law, Vaccines, Clinical Research, FDA, Clinical Development, Strategy, Quality System, Biotechnology, Biopharmaceuticals, IND, V&V
Education
The Johns Hopkins University 2007 — 2010
Masters, Bioscience Regulatory Affairs
College of Notre Dame of Maryland 2001 — 2005
BA, Biology, Chemistry
Kimberly (Gunnett) Marshall Kimberly (Gunnett) Marshall's RRD International, LLC Experience June 2010 - Present
Job Senior Program Leader at RRD International, LLC
Industry Pharmaceuticals
Experience
RRD International, LLC June 2010 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2008 - June 2010
ImClone Systems Incorporated March 2008 - July 2008
Cephalon, Inc. July 2007 - 2008
Bristol-Myers Squibb Company April 2006 - July 2007
PharmaNet June 2004 - April 2006
PharmaNet May 2000 - May 2004
Adis International 1999 - 2000
Skills
Clinical Trials, Oncology, CRO, Clinical Research, Clinical Development, Clinical Trial..., Biotechnology, EDC, GCP, Drug Development, Biopharmaceuticals, Regulatory Affairs, Clinical Monitoring, Medical Writing, Protocol, GMP, Clinical Operations, Lifesciences, Cancer, Regulatory Submissions, CTMS, FDA, Pharmaceutical Industry, ICH-GCP, 21 CFR Part 11, Clinical Data Management, Pharmaceutics
Education
Penn State University 1982 — 1986
B.S., Nursing
RRD International, LLC June 2010 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2008 - June 2010
ImClone Systems Incorporated March 2008 - July 2008
Cephalon, Inc. July 2007 - 2008
Bristol-Myers Squibb Company April 2006 - July 2007
PharmaNet June 2004 - April 2006
PharmaNet May 2000 - May 2004
Adis International 1999 - 2000
Skills
Clinical Trials, Oncology, CRO, Clinical Research, Clinical Development, Clinical Trial..., Biotechnology, EDC, GCP, Drug Development, Biopharmaceuticals, Regulatory Affairs, Clinical Monitoring, Medical Writing, Protocol, GMP, Clinical Operations, Lifesciences, Cancer, Regulatory Submissions, CTMS, FDA, Pharmaceutical Industry, ICH-GCP, 21 CFR Part 11, Clinical Data Management, Pharmaceutics
Education
Penn State University 1982 — 1986
B.S., Nursing
MacKenzie Mahoney MacKenzie Mahoney's RRD International, LLC Experience September 2010 - July 2011
Job IT Staffing Consultant at Beacon Hill Staffing Group
Industry Staffing and Recruiting
Experience
Beacon Hill Staffing Group July 2011 - Present
RRD International, LLC September 2010 - July 2011
Medtronic/ATS Medical September 2009 - September 2010
Skills
Teamwork, Project Management, Process Improvement, Quality Assurance, Software Development, Permanent Placement, Research, Recruiting, Technical Writing, Technical Support, Team Leadership, Customer Service, Temporary Placement, Medical Devices, Start-ups, Social Media, Microsoft Office, Network Administration, Information Technology, Regulatory Affairs, System Administration, Customer Satisfaction, Microsoft Excel, Applicant Tracking...
Education
University of Minnesota-Twin Cities
Biology
Wayzata High School
Beacon Hill Staffing Group July 2011 - Present
RRD International, LLC September 2010 - July 2011
Medtronic/ATS Medical September 2009 - September 2010
Skills
Teamwork, Project Management, Process Improvement, Quality Assurance, Software Development, Permanent Placement, Research, Recruiting, Technical Writing, Technical Support, Team Leadership, Customer Service, Temporary Placement, Medical Devices, Start-ups, Social Media, Microsoft Office, Network Administration, Information Technology, Regulatory Affairs, System Administration, Customer Satisfaction, Microsoft Excel, Applicant Tracking...
Education
University of Minnesota-Twin Cities
Biology
Wayzata High School
Jane Wetterau Jane Wetterau's RRD International, LLC Experience January 2011 - April 2011
Job Attorney Advisor at the U.S. Securities and Exchange Commission
Industry Law Enforcement
Experience
U.S. Securities and Exchange Commission June 2015 - Present
Financial Industry Regulatory Authority October 2012 - May 2015
US EPA September 2011 - January 2012
US Securities and Exchange Commission 2012 - 2012
US EPA May 2011 - August 2011
RRD International, LLC January 2011 - April 2011
Withers LLP June 2010 - August 2010
Skills
Securities Regulation, Legal Research, Legal Writing, Administrative Law, Litigation, Westlaw, Lexis, Alternative Dispute..., Legal Issues, Environmental Law, Employment Law, Criminal Law, International Law, Hearings, Civil Litigation, Courts, Legal Compliance
Education
American University, Washington College of Law 2010 — 2012
Doctor of Law (J.D.)
Bucknell University 2004 — 2008
Bachelor of Arts (B.A.), Psychology and Philosophy
U.S. Securities and Exchange Commission June 2015 - Present
Financial Industry Regulatory Authority October 2012 - May 2015
US EPA September 2011 - January 2012
US Securities and Exchange Commission 2012 - 2012
US EPA May 2011 - August 2011
RRD International, LLC January 2011 - April 2011
Withers LLP June 2010 - August 2010
Skills
Securities Regulation, Legal Research, Legal Writing, Administrative Law, Litigation, Westlaw, Lexis, Alternative Dispute..., Legal Issues, Environmental Law, Employment Law, Criminal Law, International Law, Hearings, Civil Litigation, Courts, Legal Compliance
Education
American University, Washington College of Law 2010 — 2012
Doctor of Law (J.D.)
Bucknell University 2004 — 2008
Bachelor of Arts (B.A.), Psychology and Philosophy
D. Nigel Thomas's RRD International, LLC Experience May 2002 - August 2006
Job
Industry Biotechnology
Experience
Novavax April 2011 - Present
Intercell AG October 2006 - January 2011
Anges August 2006 - October 2006
RRD International, LLC May 2002 - August 2006
Prestwick Clinical February 2001 - April 2002
Quintiles, Inc. 1999 - 2001
National Institute of Mental Health, NIH November 1991 - November 1994
Reckitt & Colman 1991 - 1991
Skills
Clinical Trials, Biotechnology, Clinical Development, Vaccines, CTMS, Infectious Diseases, Lifesciences, Clinical Research, CRO, GCP, Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, Clinical Operations, Biopharmaceuticals, EDC, Biologics, Clinical Monitoring, GMP, Drug Development, Technology Transfer, Validation, Patient Recruitment, Drug Discovery, R&D, Therapeutic Areas, ICH-GCP, Immunology, Clinical Data Management, Protocol, GLP, Clinical Study Design, Life Sciences
Education
University of Reading 1987 — 1991
Ph.D
The University of Reading 1984 — 1987
B.Sc (Hons.)
Wolverley High School 1978 — 1984
Novavax April 2011 - Present
Intercell AG October 2006 - January 2011
Anges August 2006 - October 2006
RRD International, LLC May 2002 - August 2006
Prestwick Clinical February 2001 - April 2002
Quintiles, Inc. 1999 - 2001
National Institute of Mental Health, NIH November 1991 - November 1994
Reckitt & Colman 1991 - 1991
Skills
Clinical Trials, Biotechnology, Clinical Development, Vaccines, CTMS, Infectious Diseases, Lifesciences, Clinical Research, CRO, GCP, Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, Clinical Operations, Biopharmaceuticals, EDC, Biologics, Clinical Monitoring, GMP, Drug Development, Technology Transfer, Validation, Patient Recruitment, Drug Discovery, R&D, Therapeutic Areas, ICH-GCP, Immunology, Clinical Data Management, Protocol, GLP, Clinical Study Design, Life Sciences
Education
University of Reading 1987 — 1991
Ph.D
The University of Reading 1984 — 1987
B.Sc (Hons.)
Wolverley High School 1978 — 1984
Maryann Krane's RRD International, LLC Experience June 2007 - Present
Job Regulatory Consultant at RRD International, LLC
Industry Biotechnology
Experience
RRD International, LLC June 2007 - Present
ARIAD Pharmaceuticals May 2001 - June 2007
Genetics Institute 1989 - 2000
Skills
Clinical Trials, IND, Vaccines, Drug Development, Quality Auditing, Quality System, CTMS, Biologics, Regulatory Requirements
Education
University of Massachusetts, Amherst 1977 — 1981
RRD International, LLC June 2007 - Present
ARIAD Pharmaceuticals May 2001 - June 2007
Genetics Institute 1989 - 2000
Skills
Clinical Trials, IND, Vaccines, Drug Development, Quality Auditing, Quality System, CTMS, Biologics, Regulatory Requirements
Education
University of Massachusetts, Amherst 1977 — 1981
Joy Bates Vander Wal's RRD International, LLC Experience June 2004 - Present
Job Sr. Director Regulatory Affairs, RRD International, LLC
Industry Biotechnology
Experience
RRD International, LLC June 2004 - Present
Quintiles, Inc July 1992 - June 2004
Skills
Regulatory Affairs, Clinical Trials, Regulatory Submissions, Clinical Development, Biologics, Biotechnology, FDA, Lifesciences, Pharmaceutical Industry, Drug Development, GCP, Product Development, IND, Clinical Research, CTMS, CRO, Vaccines
Education
Georgetown University 1985 — 1989
Oak Knoll
Oak Knoll
RRD International, LLC June 2004 - Present
Quintiles, Inc July 1992 - June 2004
Skills
Regulatory Affairs, Clinical Trials, Regulatory Submissions, Clinical Development, Biologics, Biotechnology, FDA, Lifesciences, Pharmaceutical Industry, Drug Development, GCP, Product Development, IND, Clinical Research, CTMS, CRO, Vaccines
Education
Georgetown University 1985 — 1989
Oak Knoll
Oak Knoll
Brian Gallagher, CMA's RRD International, LLC Experience October 2014 - Present
Job Senior Vice President and Chief Financial Officer at RRD International, LLC
Industry Biotechnology
Experience
RRD International, LLC October 2014 - Present
Optimer Pharmaceuticals July 2012 - February 2014
Adolor Corporation April 2004 - March 2012
Johnson & Johnson 2002 - 2004
Merck & Co 1994 - 2001
Skills
Pharmaceutical Industry, Financial Analysis, SEC filings, Forecasting, Financial Reporting, Accounting, Sarbanes-Oxley Act, Cross-functional Team..., Strategic Financial..., Sarbanes-Oxley, Due Diligence, Financial Modeling, Internal Controls, Budgets
Education
Penn State University 1989 — 1993
BS, Finance
RRD International, LLC October 2014 - Present
Optimer Pharmaceuticals July 2012 - February 2014
Adolor Corporation April 2004 - March 2012
Johnson & Johnson 2002 - 2004
Merck & Co 1994 - 2001
Skills
Pharmaceutical Industry, Financial Analysis, SEC filings, Forecasting, Financial Reporting, Accounting, Sarbanes-Oxley Act, Cross-functional Team..., Strategic Financial..., Sarbanes-Oxley, Due Diligence, Financial Modeling, Internal Controls, Budgets
Education
Penn State University 1989 — 1993
BS, Finance
Patrick Frenchick's RRD International, LLC Experience February 2009 - Present
Job VP, Scientific and Technical Operations at RRD International, LLC
Industry Biotechnology
Experience
RRD International, LLC February 2009 - Present
CytImmune Sciences June 2007 - February 2009
Combinature AG December 2006 - January 2008
VDG Consulting October 2004 - December 2006
Boehringer Ingelheim Animal Health 2001 - 2004
Endorex/DOR Biopharmaceuticals 1997 - 2001
SB Animal Health/Pfizer Animal Health 1992 - 1996
Praxis Biologics 1988 - 1992
Skills
Clinical Development, Technology Transfer, Vaccines, Drug Development, Oncology, Clinical Trials, Biotechnology, Life Sciences
Education
University of Minnesota-Twin Cities 1980 — 1984
Ph.D., Immunology, Biochemistry
RRD International, LLC February 2009 - Present
CytImmune Sciences June 2007 - February 2009
Combinature AG December 2006 - January 2008
VDG Consulting October 2004 - December 2006
Boehringer Ingelheim Animal Health 2001 - 2004
Endorex/DOR Biopharmaceuticals 1997 - 2001
SB Animal Health/Pfizer Animal Health 1992 - 1996
Praxis Biologics 1988 - 1992
Skills
Clinical Development, Technology Transfer, Vaccines, Drug Development, Oncology, Clinical Trials, Biotechnology, Life Sciences
Education
University of Minnesota-Twin Cities 1980 — 1984
Ph.D., Immunology, Biochemistry
John Sirisouk's RRD International, LLC Experience 2002 - 2004
Job CEO at Kingrich Inc
Industry Wholesale
Experience
Kingrich Inc July 2015 - Present
Stratton Solutions April 2014 - Present
INTERWIRE PRODUCTS June 2006 - February 2014
RRD International, LLC 2002 - 2004
Skills
Microsoft Excel, Customer Service, Financial Analysis, Process Improvement, SAP, Sales
Education
University of Central Florida 1998 — 2000
Kingrich Inc July 2015 - Present
Stratton Solutions April 2014 - Present
INTERWIRE PRODUCTS June 2006 - February 2014
RRD International, LLC 2002 - 2004
Skills
Microsoft Excel, Customer Service, Financial Analysis, Process Improvement, SAP, Sales
Education
University of Central Florida 1998 — 2000
Kathy Arbuthnott's RRD International, LLC Experience August 2010 - June 2011
Job Regulatory Affairs Consulting and Regulatory Medical Writing
Industry Biotechnology
Experience
Independent Contractor February 2014 - Present
PRA International October 2012 - February 2014
STB Lifesaving Technologies July 2011 - September 2012
RRD International, LLC August 2010 - June 2011
CROfessionals July 2006 - August 2010
Emergent BioSolutions April 2005 - June 2006
Biosynexus Incorporated 2000 - 2005
Sunol Molecular Corporation 1996 - 2000
Skills
Regulatory Affairs, Regulatory Submissions, Microbiology, Medical Writing, Biotechnology, Quality System, Sop, Quality Auditing, Clinical Trials, FDA, Clinical Development, GCP, IND, GLP, Pharmaceutical Industry, Lifesciences, Quality Assurance, Regulatory Requirements, Vaccines, Drug Development, CAPA, Pharmacovigilance, CRO
Education
Florida Atlantic University
BS, Microbiology
Independent Contractor February 2014 - Present
PRA International October 2012 - February 2014
STB Lifesaving Technologies July 2011 - September 2012
RRD International, LLC August 2010 - June 2011
CROfessionals July 2006 - August 2010
Emergent BioSolutions April 2005 - June 2006
Biosynexus Incorporated 2000 - 2005
Sunol Molecular Corporation 1996 - 2000
Skills
Regulatory Affairs, Regulatory Submissions, Microbiology, Medical Writing, Biotechnology, Quality System, Sop, Quality Auditing, Clinical Trials, FDA, Clinical Development, GCP, IND, GLP, Pharmaceutical Industry, Lifesciences, Quality Assurance, Regulatory Requirements, Vaccines, Drug Development, CAPA, Pharmacovigilance, CRO
Education
Florida Atlantic University
BS, Microbiology
Elizabeth Krause's RRD International, LLC Experience November 2010 - Present
Job Medical Writer in the DC Metro Area
Industry Pharmaceuticals
Experience
RRD International, LLC November 2010 - Present
Bridge Laboratories January 2009 - December 2009
Bridge Laboratories May 2008 - January 2009
Bridge Laboratories February 2007 - May 2008
Bridge Laboratories August 2006 - February 2007
Gene Logic, Inc. June 2006 - August 2006
Gene Logic, Inc. December 2004 - June 2006
Education
The Johns Hopkins University - Carey Business School 2007 — 2010
MBA, Business
St. Mary's College of Maryland, St. Mary's
Bachelor of Arts, Biology
The Johns Hopkins University
Masters of Science/Masters of Business Administration, Biotechnology
RRD International, LLC November 2010 - Present
Bridge Laboratories January 2009 - December 2009
Bridge Laboratories May 2008 - January 2009
Bridge Laboratories February 2007 - May 2008
Bridge Laboratories August 2006 - February 2007
Gene Logic, Inc. June 2006 - August 2006
Gene Logic, Inc. December 2004 - June 2006
Education
The Johns Hopkins University - Carey Business School 2007 — 2010
MBA, Business
St. Mary's College of Maryland, St. Mary's
Bachelor of Arts, Biology
The Johns Hopkins University
Masters of Science/Masters of Business Administration, Biotechnology
Katie Laessig, MD's RRD International, LLC Experience April 2015 - Present
Job Senior Vice President, Regulatory Affairs and Medical Safety
Industry Pharmaceuticals
Experience
RRD International, LLC April 2015 - Present
Division of Anti-Infective Products Food and Drug Administration July 2007 - March 2015
Division of Antiviral Products, FDA May 2001 - July 2007
Division of Antiviral Products, FDA January 1999 - May 2001
Kaiser Permanente July 1997 - January 1999
Skills
Clinical Trials, Drug Development, Regulatory Requirements, Infectious Diseases, Viral Hepatitis, HIV, Biologics, IND, NDA, BLA, Animal Rule, Management, Medicine, Regulatory Affairs, Clinical Development, Clinical Pharmacology, Global Health, Medical Writing, FDA, Clinical Study Design, Outcomes Research, Pharmacokinetics, Biotechnology, Public Health, Immunology, Biopharmaceuticals, Virology, Regulatory Submissions, Pharmaceutical Industry, Pharmacovigilance, Pharmacology, Toxicology, Protocol
Education
University of Maryland School of Medicine 1988 — 1992
MD, Medicine
Cornell University 1984 — 1988
BA, Biology-microbiology
Bethesda Chevy Chase High School 1980 — 1984
High School Diploma
RRD International, LLC April 2015 - Present
Division of Anti-Infective Products Food and Drug Administration July 2007 - March 2015
Division of Antiviral Products, FDA May 2001 - July 2007
Division of Antiviral Products, FDA January 1999 - May 2001
Kaiser Permanente July 1997 - January 1999
Skills
Clinical Trials, Drug Development, Regulatory Requirements, Infectious Diseases, Viral Hepatitis, HIV, Biologics, IND, NDA, BLA, Animal Rule, Management, Medicine, Regulatory Affairs, Clinical Development, Clinical Pharmacology, Global Health, Medical Writing, FDA, Clinical Study Design, Outcomes Research, Pharmacokinetics, Biotechnology, Public Health, Immunology, Biopharmaceuticals, Virology, Regulatory Submissions, Pharmaceutical Industry, Pharmacovigilance, Pharmacology, Toxicology, Protocol
Education
University of Maryland School of Medicine 1988 — 1992
MD, Medicine
Cornell University 1984 — 1988
BA, Biology-microbiology
Bethesda Chevy Chase High School 1980 — 1984
High School Diploma
Curtis Scribner's RRD International, LLC Experience July 2006 - December 2014
Job Independent BioTech Regulatory Consultant
Industry Pharmaceuticals
Experience
RRD International, LLC July 2006 - December 2014
Intarcia Therapeutics January 2000 - July 2006
Quintiles Consulting September 1997 - December 1999
FDA June 1987 - September 1997
Education
University of Maryland - Robert H. Smith School of Business 1993 — 1995
MBA
University of Colorado School of Medicine 1973 — 1977
MD
Grinnell College 1969 — 1973
BA, Biology
RRD International, LLC July 2006 - December 2014
Intarcia Therapeutics January 2000 - July 2006
Quintiles Consulting September 1997 - December 1999
FDA June 1987 - September 1997
Education
University of Maryland - Robert H. Smith School of Business 1993 — 1995
MBA
University of Colorado School of Medicine 1973 — 1977
MD
Grinnell College 1969 — 1973
BA, Biology
Mirette Eldeiry's RRD International, LLC Experience Commercial credit ManagerRR Donnelley2003 - Present
Job Vice President at The Situs Company
Industry Financial Services
Doris Westhoff's RRD International, LLC Experience Senior Manager Biologicals, Head of Department for Clincial Field TrialsBoehringer Ingelheim Vetmedica GmbH GermanyJanuary 2006 - March 2008
Job Senior Project Manager at RRD International, LLC
Industry Biotechnology
Experience
RRD International, LLC Senior Manager Biologicals, Head of Department for Clincial Field TrialsBoehringer Ingelheim Vetmedica GmbH GermanyJanuary 2006 - March 2008
Cangene Corporation November 2005 - December 2006
Boehringer Ingelheim Vetmedica GmbH Germany February 2001 - October 2005
Wyeth Pharma GmbH October 1996 - January 2001
Education
University of Münster 1985 — 1996
Dr. rer. nat., Biology
RRD International, LLC Senior Manager Biologicals, Head of Department for Clincial Field TrialsBoehringer Ingelheim Vetmedica GmbH GermanyJanuary 2006 - March 2008
Cangene Corporation November 2005 - December 2006
Boehringer Ingelheim Vetmedica GmbH Germany February 2001 - October 2005
Wyeth Pharma GmbH October 1996 - January 2001
Education
University of Münster 1985 — 1996
Dr. rer. nat., Biology
Margaret Kautz's RRD International, LLC Experience January 2015 - Present
Job Senior Manager, Regulatory Affairs, RRD International, LLC
Industry Pharmaceuticals
Experience
RRD International, LLC January 2015 - Present
RRD International, LLC January 2012 - December 2014
RRD International, LLC September 2009 - December 2011
RRD International, LLC January 2005 - August 2009
Merck March 2004 - December 2004
Merck Sharp & Dohme April 2001 - March 2004
Thomas Jefferson University Hospitals and Contract Nursing August 1999 - April 2001
University of Pennsylvania Clinical Center for Epidemiology and Biostatistics April 2000 - January 2001
Massachusetts General Hospital September 1998 - July 1999
Medstar Washington Hospital Center July 1996 - August 1998
Skills
Regulatory Affairs, Clinical Trials, Clinical Research, Regulatory Submissions, Clinical Development, Vaccines, Biotechnology, GCP, Drug Development, CTMS, CRO, Clinical Monitoring, FDA, Medical Writing, Infectious Diseases
Education
University of Pennsylvania 1999 — 2000
MSN, Nursing and Healthcare Administration
Boston College 1992 — 1996
BSN, Nursing
RRD International, LLC January 2015 - Present
RRD International, LLC January 2012 - December 2014
RRD International, LLC September 2009 - December 2011
RRD International, LLC January 2005 - August 2009
Merck March 2004 - December 2004
Merck Sharp & Dohme April 2001 - March 2004
Thomas Jefferson University Hospitals and Contract Nursing August 1999 - April 2001
University of Pennsylvania Clinical Center for Epidemiology and Biostatistics April 2000 - January 2001
Massachusetts General Hospital September 1998 - July 1999
Medstar Washington Hospital Center July 1996 - August 1998
Skills
Regulatory Affairs, Clinical Trials, Clinical Research, Regulatory Submissions, Clinical Development, Vaccines, Biotechnology, GCP, Drug Development, CTMS, CRO, Clinical Monitoring, FDA, Medical Writing, Infectious Diseases
Education
University of Pennsylvania 1999 — 2000
MSN, Nursing and Healthcare Administration
Boston College 1992 — 1996
BSN, Nursing
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY