Ora (Ophthalmic Research Associates)
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Ora (Ophthalmic Research Associates) Employees
Ora (Ophthalmic Research Associates) November 2014 - Present
Shire Pharmaceuticals March 2014 - September 2014
Eisai Inc/MGI Pharma September 2004 - December 2013
ZYCOS Inc. January 1998 - September 2004
Cambridge Scientific Inc.. September 1997 - December 1998
Center for Biotechnology Engineering at Northeastern University September 1991 - June 1996
Skills
Formulation, CMC, Pharmaceutical Industry, contract manufacturing..., controlled drug release..., CMC management, Protein Production, process scale up, Contract Manufacturing, Monoclonal Antibodies, Technology Transfer, Scalability, Regulatory Submissions, GMP, Protein Chemistry, Drug Development, FDA, CAPA, Change Control, Drug Delivery, Biotechnology, Analytical Chemistry, Process Simulation
Education
Northeastern University 1993 — 1996
Ph.D, Chemical Engineering
Northeastern University 1991 — 1993
Master's degree, Chemical Engineering
Tunghai University 1984 — 1989
Bachelor's degree, Chemical Engineering
Ora (Ophthalmic Research Associates) November 2014 - Present
Boston Children's Hospital June 2011 - October 2014
Boston Children's Hospital March 2010 - October 2014
Boston Children's Hospital June 2009 - June 2011
Boston Children's Hospital January 2008 - March 2010
Skills
Clinical Trials, Project Management, Clinical Research, Leadership, Healthcare, Hospitals, Medical Devices, Pediatrics, Project Coordination, Research, Clinical Data Management, Public Health, Data Analysis, Healthcare Information..., Medicine, Ophthalmology, Neuroscience, Public Speaking, Lifesciences, Risk Management, Scientific Writing, Biotechnology
Education
Boston University 2012 — 2014
Master of Science, Project Management
Dalhousie University 2009 — 2011
Graduate Degree, Clinical Vision Science and Ophthalmic Medical Technology
Northeastern University 2003 — 2008
BS, Behavioral Neuroscience
Ora (Ophthalmic Research Associates) August 2014 - Present
Covidien January 2014 - August 2014
EBSCO Information Services June 2013 - September 2013
Memorial Sloan-Kettering Cancer Center June 2010 - September 2012
University of Massachusetts, Medical School September 2003 - June 2010
University of Delhi, Dept. of Plant Molecular Biology July 2002 - May 2003
Skills
Tissue Culture, Molecular Biology, Cell Culture, Biochemistry, Microscopy, Immunology, Transfection, Western Blotting, Clinical Research, Clinical Trials, Clinical Development, Oncology, Life Sciences, PCR, Research, Laboratory, Biotechnology
Education
UMass Medical School 2003 — 2010
Doctor of Philosophy (PhD), Biomedical Sciences, General
University of Delhi 2001 — 2003
M. Sc, Dept. of Plant Molecular Biology
Unversity of Delhi 1998 — 2001
B.Sc, Dept. of Biochemistry
Springdales
Pathfinder Bio February 2015 - Present
Voyager Therapeutics, Inc. January 2014 - February 2015
Third Rock Ventures July 2011 - January 2014
Advanced Technology Ventures June 2010 - March 2011
Harvard Business School September 2009 - August 2010
Ora (Ophthalmic Research Associates) September 2008 - August 2009
Ora (Ophthalmic Research Associates) March 2008 - September 2008
Ora (Ophthalmic Research Associates) 2007 - 2008
Education
Harvard Business School 2009 — 2011
MBA
Colby College 2002 — 2006
BA, English
Ora (Ophthalmic Research Associates) May 2010 - February 2011
Broad Institute September 2007 - May 2010
Brigham and Women's Hospital September 2006 - August 2007
Joslin Diabetes Center January 2004 - May 2007
Education
MCPHS University 2011 — 2014
Doctor of Pharmacy (Pharm.D.)
Simmons College 2003 — 2007
BS, Society & Health, Biochemistry
Lowell High School 1999 — 2003
High School
DePuy Spine May 2013 - Present
TEI Biosciences Inc. January 2011 - May 2013
Ora (Ophthalmic Research Associates) July 2007 - November 2010
Skills
FDA, Clinical Trials, Biotechnology, CRO, Clinical Development, Clinical Research, Public Speaking, Medical Devices, Clinical Monitoring, GCP, Oncology, Lifesciences
Education
Babson College - Franklin W. Olin Graduate School of Business 2014 — 2016
Master of Business Administration (M.B.A.)
Bowdoin College 2003 — 2007
Bachelor of Science, Neuroscience
Ora (Ophthalmic Research Associates) January 2013 - Present
Partners HealthCare August 2010 - January 2013
Cell Signaling Technology January 2005 - August 2010
Skills
Intellectual Property, Patents, Licensing, Contract Negotiation, Technology Transfer, Business Development, Patent Prosecution, Trademarks, Copyright Law, Medical Devices, Commercialization, Patent Litigation, Biotechnology, Trademark Infringement, Patentability, Lifesciences, Client Counseling, Non-disclosure..., Intellectual Property..., Life Sciences, Privacy Law
Education
Franklin Pierce Law Center 2001 — 2004
J.D., cum laude, Law - Intellectual Property
State University of New York at Geneseo 1997 — 2000
B.S., Biology, 2nd Major Economics
RJT Research Consulting, LLC May 2013 - Present
Ora January 2012 - September 2012
Ora (Ophthalmic Research Associates) July 2007 - January 2012
Advanced Arthritis Care & Research November 2005 - July 2007
Education
Arizona State University, W. P. Carey School of Business 2001 — 2005
Bachelor of Science, Marketing
Ora (Ophthalmic Research Associates) November 2010 - Present
Kendle International April 2008 - November 2010
PPD Global Central Labs April 2004 - April 2008
Cambrex April 2002 - April 2004
Dell Computer Corporation September 1999 - September 2001
Iomega July 1997 - September 1999
Johnson & Johnson (Ethicon Endo-Surgery) June 1992 - July 1997
Rockwell International June 1988 - June 1992
Skills
Forecasting, Financial Modeling, Analysis, Cross-functional Team..., Finance, Leadership, Management, Pharmaceutical Industry, Process Improvement, Strategic Planning
Education
The Ohio State University Fisher College of Business
MBA, International Business
University of Cincinnati
B.A., Economics
Certified Management Accountant
CMA - 1994
Diplomate in Laboratory Mgmt(ASCP)
DLM(ASCP) - 2010
Ora, Inc. March 2015 - Present
Ora (Ophthalmic Research Associates) February 2007 - February 2015
Skills
Pharmaceutical Industry, GCP, Clinical Trials, Clinical Development, CRO, ICH-GCP, Protocol, FDA, Management, CTMS, Drug Development, Regulatory Submissions
Education
Southern New Hampshire University
B.S., Business Administration
NH Institute for Therapeutic Arts 2002 — 2003
Licensed Massage Therapist, Nationally Certified
ESOL Career Pathways Bridge at NECC December 2012 - Present
Northern Essex Community College September 2012 - Present
Haverhill Public Schools July 2011 - June 2012
Upward Bound June 2011 - August 2011
Dover Public Schools August 2010 - June 2011
OneSky Community Services June 2010 - June 2011
University of New Hampshire August 2005 - January 2011
Ora (Ophthalmic Research Associates) August 2008 - March 2010
Glengyle Research April 2008 - November 2008
New Hampshire Public Television June 2007 - August 2007
Skills
English, Teaching English as a..., Research, Teaching, Editing, Tutoring, Teaching Adults, Teaching Writing, College Teaching, Higher Education, Classroom, ESL, Grant Writing, Curriculum Design, Public Speaking, Writing, Curriculum Development, Community Outreach, Program Development, Nonprofits
Education
University of New Hampshire 2010 — 2011
MAT, Teaching English and ESOL
University of New Hampshire 2005 — 2008
B.A, English, Political Science
Ora June 2013 - Present
Ophthalmic Research Associates, Inc. 2011 - June 2013
Ora (Ophthalmic Research Associates) September 2001 - January 2010
Skills
Clinical Research, ICH-GCP, GCP, Clinical Development, Process Improvement, CRO, Clinical Trials, Pharmaceutical Industry, FDA, Biotechnology, Protocol, EDC, SOP
Education
Bay Path University
Bachelor's Degree, Liberal Arts and Sciences/Liberal Studies
Alcon, a Novartis company December 2014 - Present
inVentiv Health Clinical May 2014 - November 2014
Alcon Laboratories, Inc. September 2010 - April 2014
Ora (Ophthalmic Research Associates) December 2007 - September 2010
Barnes Retina Institute June 2002 - November 2007
Gateway Medical Research September 1995 - May 2002
Skills
Ophthalmology, Clinical Research, GCP, Clinical Monitoring, Clinical Trials, CRO, ICH-GCP, EDC, Regulatory Submissions, Medical Devices, Protocol, Pharmaceutical Industry, CTMS, IND, Therapeutic Areas, IRB, Clinical Operations
Education
The George Washington University School of Medicine and Health Sciences
Bachelor of Science-Health Sciences, Health Science/Clinical Research Administration
Maryville University of Saint Louis
Associate of Applied Science, Respiratory Therapy-Cardiopulmonary Technology
CBSET, Inc. February 2012 - Present
Ora (Ophthalmic Research Associates) June 2010 - December 2010
Charles River Laboratories May 1999 - May 2010
GTC / Primedica Laboratories January 1995 - April 1999
TSI/GTC Laboratories 1992 - 1994
EGG/TSI Mason Laboratories 1988 - 1992
Skills
Pharmacology, Research, GLP, Toxicology, Clinical, CRO, Outlook, PowerPoint, Word, Excel, Data Collection, Data Management, SOP, Documentation, Life Sciences, Biotechnology, Clinical Research, Microsoft Office, Data Entry, Scheduling, Customer Relations, Mentoring, Pharmaceuticals, Medical Devices, Quality Assurance, Clinical Trials, Access, Writing, Supervisory Skills, GCP, Clinical Development, Software Documentation, Sop
Education
University of Massachusetts Dartmouth 1985 — 1988
BS, Biology, Marine Biology
University of New England 1983 — 1985
Marine Biology
Ora (Ophthalmic Research Associates) December 2009 - Present
Ora Inc. September 2006 - November 2009
Skills
Pharmaceutical Industry, Clinical Development, Clinical Trials, Medical Devices, Biotechnology, FDA, CRO, Protocol, Sop, GCP, Clinical Research, Lifesciences, Regulatory Submissions, Regulatory Affairs, Drug Development, R&D, Technology Transfer, GLP, Data Analysis, Validation, Drug Delivery, IND, Life Sciences, Medical Writing
Education
Boston University 2013 — 2016
Master of Business Administration (MBA), Health/Health Care Administration/Management
Bates College 1999 — 2003
Bachelor’s Degree, Biology, General
Medivector Inc March 2015 - Present
ARIAD Pharmaceuticals, Inc. July 2014 - March 2015
ARIAD Pharmaceuticals, Inc. May 2012 - July 2014
Quintiles Outcome October 2010 - May 2012
Synchrogenix April 2010 - October 2010
Ora (Ophthalmic Research Associates) 2007 - 2010
Ora (Ophthalmic Research Associates) 2004 - 2007
Lonza April 2004 - January 2005
Skills
Medical Writing, Clinical Trials, Pharmaceutical Industry, Biotechnology, Oncology, Clinical Research, Clinical Development, GCP, CRO, Protocol, Lifesciences, Regulatory Submissions, Infectious Diseases, Sop, FDA, ICH-GCP, Pharmacovigilance, Therapeutic Areas, Medicine, Medical Communications, Clinical Study Design, EDC, Medical Affairs, Clinical Monitoring, Neurology, Drug Development, Life Sciences, SOP
Education
Boston University 2012 — 2014
Master of Science (MS), Health Communication
Bates College 2000 — 2004
BS, Biology, Music
Ora, Inc. March 2015 - Present
Ora (Ophthalmic Research Associates) July 2013 - March 2015
Ora, Inc July 2012 - July 2013
Bates College September 2008 - May 2012
Bates College September 2011 - January 2012
NorthShore University HealthSystem June 2011 - September 2011
Bates College September 2010 - December 2010
Northwestern Memorial Hospital June 2010 - September 2010
Chicago Chamber Musicians June 2009 - September 2009
University of Chicago Hospitals June 2007 - May 2008
Skills
Biochemistry, Molecular Biology, Laboratory, Experimental Design, Biotechnology, Research, Data Analysis, Statistics, PowerPoint, Microsoft Office, Microsoft Excel, Editing, Public Speaking, Market Research, Lifesciences, Life Sciences
Education
Bates College 2008 — 2012
B.S., Biological Chemistry
University of Chicago Lab School 2004 — 2008
High School Diploma, High School Curriculum
Smith & Nephew November 2013 - Present
Boston Children's Hospital February 2010 - November 2013
Ora (Ophthalmic Research Associates) February 2008 - January 2010
Massachusetts General Hospital February 2004 - February 2008
Genzyme November 1998 - January 2004
Tufts Medical Center October 1987 - November 1998
The Minneapolis Children's Medical Center July 1986 - September 1987
Fort Worth Children's Medical Center July 1984 - May 1986
Boston Children's Hospital July 1982 - May 1984
Tufts Medical Center May 1981 - July 1982
Skills
Clinical Trials, Clinical Development, Pharmaceutical Industry, CTMS, Biotechnology, GCP, Clinical Monitoring, Clinical Research, SOP, EDC, Medical Devices, Cystic Fibrosis, Pediatric Pulmonology, Asthma, Drug Development
Education
McGill University 1977 — 1981
Bachelor of Science (BSc), Registered Nursing/Registered Nurse
Covance March 2015 - Present
Ora (Ophthalmic Research Associates) January 2014 - March 2015
Ora (Ophthalmic Research Associates) January 2013 - December 2013
Massachusetts Republican Party January 2011 - December 2012
Skills
Fundraising, Political Campaigns, Leadership, Data Analysis, Research, Budgets, Strategic Planning, Policy, Nonprofits, Government, Public Policy, Time Management, Highly detail oriented, Event Planning, GCP, TMF, Clinical Research, Community Outreach, Organization, Clinical Trials, Dry Eye, Allergy, Medical Devices
Education
Fisher College
Bachelor of Science (BS), Business Administration and Management, General
EnerNOC July 2014 - Present
EnerNOC June 2012 - June 2014
EnerNOC April 2011 - June 2012
Ora (Ophthalmic Research Associates) February 2010 - April 2011
Ora (Ophthalmic Research Associates) August 2008 - January 2010
Skills
Product Development, New Business Development, Business Planning, Energy Efficiency, CRO, Biotechnology, Clinical Trials, Pharmaceutical Industry, Clinical Research, Research, Clinical Development, Strategic Planning, Market Research, Energy, Business Development, Salesforce.com, Start-ups
Education
Bates College
Bachelor of Arts, Sociology with concentration in Economics
Gould Academy
Ora (Ophthalmic Research Associates) August 2013 - Present
The Princeton House March 2013 - August 2013
Perceptive Informatics, Inc. (PAREXEL) September 2011 - February 2013
Perceptive Informatics, Inc. (PAREXEL) February 2010 - September 2011
Perceptive Informatics, Inc. (PAREXEL) August 2008 - February 2010
Hands On Technology Transfer, Inc. September 2007 - February 2008
TD Bank April 2005 - August 2007
Skills
Clinical Research, Clinical Trials, Medical Imaging, Oncology, Pharmaceutical Industry, Digital Imaging, Microsoft Office, Customer Service, Microsoft Excel, GCP, Medical Devices, Biotechnology, Clinical Data Management, ICH-GCP, FDA, CTMS, EDC, Quality Assurance, IWRS, SOP, 21 CFR Part 11, Sop, CRO, Clinical Development, Management, Life Sciences, Protocol, Regulatory Affairs, Healthcare, Research, Leadership
Education
Keene State College 2005 — 2007
A.S, Chemical Dependency
Keene State College 2003 — 2007
B.A, Psychology, Clinical/Counseling
Pinkerton Academy 1999 — 2003
ORA, Inc February 1998 - May 2013
Ora (Ophthalmic Research Associates) 1998 - May 2013
Skills
Protocol
Education
Boston College 1964 — 1968
Iconic Therapeutics August 2014 - Present
Acucela Inc. October 2012 - August 2014
Pharmaceutical and Biotech Companies May 2012 - October 2012
Ora (Ophthalmic Research Associates) February 2011 - May 2012
Dow Pharmaceutical Sciences March 2008 - October 2010
Dynavax Technologies 2005 - 2008
Santen Inc 1999 - 2005
Santen Inc 1997 - 1999
Allergan 1990 - 1997
Skills
Clinical Trials, Clinical Trial..., Ophthalmology, Dermatology, CRO, GCP, Clinical Research, Pharmaceuticals, Clinical Operations, Clinical Development, Medical Writing, Drug Development, CTMS, Pharmaceutical Industry, Biotechnology, Clinical Data Management, Protocol, Clinical Study Design, FDA, Biostatistics, Regulatory Submissions, Therapeutic Areas, Sop, Oncology, Data Management, EDC, SOP
Education
University of California, Riverside
BS, Biochemistry
Ora (Ophthalmic Research Associates) 2010 - Present
Ora (Ophthalmic Research Associates) 2008 - 2010
Alkermes 2005 - 2008
Alkermes 2001 - 2005
Alkermes 1998 - 2001
Skills
Product Development, Clinical Development, Regulatory Submissions, Clinical Supplies, CMO management, Sterile dosage forms, Stage-Gate, CMC Regulatory Affairs, CTD, Investigator Brochures, Stability Programs, Analytical Methods..., Stability Testing, Dry Powder Inhalers, Nasal, cGMP manufacturing, Combination Products, Drug Development, Validation, FDA, IND, Drug Discovery, Pharmaceutical Industry, Technology Transfer, Lifesciences
Education
Pennsylvania State University 1994 — 1998
B.S., Chemical Engineering
Sunovion Pharmaceuticals Inc. April 2015 - Present
Sunovion Pharmaceuticals Inc. March 2008 - Present
Sepracor June 1998 - March 2008
Serono Laboratories 1996 - 1998
Ora (Ophthalmic Research Associates) 1991 - 1996
Skills
Clinical Trials, Clinical Research, Pharmaceutical Industry, FDA, Medical Devices, Clinical Development, Biotechnology, Regulatory Submissions, Drug Development, Infectious Diseases, Medical Affairs, Cross-functional Team..., Oncology, Neurology, Commercialization
Education
Boston University
Master's degree, Applied Anatomy & Physiology
University of South Carolina-Columbia
Bachelor of Applied Science (B.A.Sc.), Kinesiology and Exercise Science
Massachusetts General Hospital November 2013 - Present
Massachusetts General Hospital March 2011 - November 2013
Ora (Ophthalmic Research Associates) 2009 - 2011
Folly Farm, LLC June 2003 - September 2009
Roger Williams University January 2008 - May 2008
Ohio State University August 2005 - August 2005
Skills
Clinical Trials, Clinical Research, GCP, EDC, FDA, Protocol, SOP, Pharmaceutical Industry, ICH-GCP, Science, Healthcare, IATA
Education
Roger Williams University 2005 — 2008
BS, Biology
Randolph-Macon Woman's College 2005 — 2005
Ora (Ophthalmic Research Associates) January 2014 - Present
PAREXEL August 2011 - April 2013
Nexcelom Bioscience October 2009 - August 2011
Homisco May 2009 - October 2009
Brooks School Day Camp June 2004 - August 2008
Skills
Business Development, Marketing Strategy, Biotechnology, Product Management, Project Management, Lifesciences, Pharmaceutical Industry, Sales, New Business Development, Marketing, Competitive Intelligence, Product Development, Market Research, Medical Devices, Online Marketing, CRO, Training, Lead Generation, Email Marketing, Life Sciences
Education
Southern New Hampshire University 2010 — 2013
MBA, Marketing
Assumption College 2005 — 2009
BA, Business Management
Central Catholic High School 2001 — 2005
Timberlane
City and County of Honolulu December 2010 - November 2012
Synchrogenix Communication Strategies, Inc. October 2008 - May 2009
Ora (Ophthalmic Research Associates) June 2007 - July 2008
Othera Pharmaceuticals August 2003 - January 2007
The University of Iowa August 1999 - January 2000
University of Illinois at Urbana-Champaign August 1998 - January 1999
Skills
Project Management, Project Control, Project Planning, Project Delivery, Technical Writing, Technical Presentations, Senior Stakeholder..., Training, International Project..., Pharmaceutical Industry, Pharmaceutical Project..., Transit-oriented..., Transportation Planning, Construction Management, Strategic Communications, Internal & External..., Foreign Languages, University Teaching, Teaching Writing, Information Systems, Program Management, Contract Management, MS Project, Regulatory Affairs, Process Scheduler, Procurement, Quality Assurance, FDA, Proposal Writing, Drug Development, Clinical Trials, Policy, Medical Writing, GCP, Project Coordination, Biotechnology, Clinical Development, Civil Engineering, Budgets, Analysis, Construction, GMP, Government, Business Development
Education
University of Illinois at Urbana-Champaign 1992 — 2000
Ph.D.
European University Institute, San Domenico, Italy 1994 — 1997
Visiting Researcher
Institut d'Etudes politiques de Paris 1991 — 1992
Diplome d'etudes approfondies (D.E.A.)
University of Illinois at Urbana-Champaign 1990 — 1992
Master of Arts (M.A.)
Ora (Ophthalmic Research Associates) January 2000 - Present
ORA Clinical Research and Development, Inc January 2000 - Present
Ora, Inc. 2000 - Present
Ora, Inc. 2000 - 2015
Caritas Holy Family Hospital and Medical Center December 1986 - June 2006
Caritas Holy Family Hospital and Medical Center June 1981 - December 1986
Telemetry/Medical/Surgical nursing care December 1982 - January 1986
Holy Family Hospital and Medical Center June 1981 - December 1982
Skills
Clinical Research, Clinical Trials, EDC, Nursing, Healthcare, GCP, ICH-GCP, Clinical Monitoring, CRO, CTMS, Clinical Development, Protocol, Critical Care, Pharmacovigilance, Inform, Clinical Data Management, Clinical Operations, Pharmaceutical Industry, Clinical Study Design, Ophthalmology, IRB
Education
Salem State College 1996 — 2001
Bachelors of Science, Nursing
Salem State University 1996 — 2001
BSN, Nursing
Lowell General Hospital School of Nursing 1978 — 1981
Nursing Diploma
Ora (Ophthalmic Research Associates) June 2010 - Present
Ora March 2010 - June 2010
Ora, Inc. December 2008 - March 2010
Skills
CRO, Clinical Development, Clinical Trials, Pharmaceutical Industry, Drug Development, Ophthalmology, Biotechnology, GCP, Clinical Research, CTMS, EDC, Life Sciences, Medical Devices, ICH-GCP, FDA, SOP, Protocol, Regulatory Affairs
Education
Brandeis University 2003 — 2007
Bachelor's degree, Biology, Economics
American International School in Israel
ConforMIS, Inc. December 2011 - Present
Ora (Ophthalmic Research Associates) April 2011 - December 2011
Ora Inc. 2010 - 2011
Ora Inc. 2009 - 2010
Ora Inc. 2008 - 2009
Wyeth Biotech 2007 - 2007
Acusphere, Inc. 2006 - 2006
Hugh O'Brian Youth Foundation of New Jersey / NJ HOBY 2002 - 2004
Skills
Patient Recruitment, Pharmaceutical Industry, Clinical Development, ICH-GCP, EDC, Clinical Operations, Protocol, Ophthalmology, Clinical Data Management, Clinical Research, Medical Writing, Sop, FDA, Drug Development, Regulatory Affairs, Pharmacovigilance, Clinical Study Design, Clinical Research...
Education
University of New Hampshire 2004 — 2008
Biology, Genetics