Pharmalink Consulting
Industry: Company
DescriptionPharmalink Consulting is a Global regulatory affairs consultancy based in UK, US, India, Singapore and Latin America which provides regulatory expertise and resource to the healthcare industry. Founded: 1998 Parent organization: GenpactFeedbackDisclaimer Claim this knowledge panel Knowledge ResultSee outside Moved, closed, or was never hereReportPharmalink ConsultingWebsiteDirections Saved (0) Saved Save Consultant in San Francisco, California Address: One Market Street Spear Tower,, 35th and 36th Floors, San Francisco, CA 94105 Phone: (415) 293-8482Website: : Place name: : Category: Hours: : : : : Website: http://www.pharmalinkconsulting.com/ Category: Consultant 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. · Own this business?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 Pharmalink Consulting Posting publicly on the Web Write a review Reviews Be the first to review
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Pharmalink Consulting Employees
Third Party Review Group LLC August 2015 - Present
Pharmalink Consulting December 2013 - July 2015
TD 2008 - 2013
Citi 2006 - 2008
Skills
Strategy, Business Development, Equities, Equity Trading, Pharmaceutical Industry, Biotechnology, Capital Markets, Trading, Hedge Funds, Fixed Income
Education
Hobart College 1994 — 1998
Bachelor of Arts (BA), Political Science and Government
Pyxa Solutions August 2012 - Present
Pharmalink Consulting March 2012 - September 2012
Shire Pharmaceuticals July 2011 - June 2012
Digitas Health September 2010 - July 2011
Pfizer November 2009 - September 2010
Schering-Plough Research Institute February 2009 - November 2009
Cosmetic Essence Inc August 2008 - December 2008
Cosmetic Essence Inc May 2008 - August 2008
Ambient Consulting January 2008 - May 2008
Skills
Corporate Communications, Regulatory Submissions, FDA, Clinical Trials, Regulatory Affairs, eCTD, Pharmaceutical Industry, IND, CMC, Regulatory Requirements, GMP, Medical Writing, Pharmaceutics, Document Management, Lifesciences, Biotechnology, NDA, ANDA, Quality Assurance, ICH-GCP, Pharmacovigilance, Change Control
Education
Temple University 2011 — 2013
Master of Science (MSc), Quality Assurance / Regulatory Affairs - Drug Development
LIU Post 2006 — 2008
Bachelors, Forensic Science with a minor in Chemistry
University of the Sciences in Philadelphia 2002 — 2004
PPD February 2015 - Present
Cardinal Health June 2012 - February 2015
Pharmalink Consulting January 2012 - July 2012
Tunnell Consulting October 2010 - January 2012
Merck January 2010 - October 2010
Johnson & Johnson April 2003 - January 2010
3-Dimensional Pharmaceuticals May 2001 - April 2003
Robert Guthrie Biochemical Genetics Laboratory October 1997 - August 1999
Bristol-Myers Squibb October 1997 - November 1998
SUNY College of Environmental Science and Forestry August 1993 - October 1996
Skills
Analytical Chemistry, Biochemistry, Organic Chemistry, Online Communications, Medicinal Chemistry, eCTD, CMC, Project Management, Regulatory Affairs, Medical Writing
Education
University at Buffalo 1999 — 2001
MS, Medicinal Chemistry
State University of New York College of Environmental Sciences and Forestry 1992 — 1996
BS, Chemistry Biochemistry
IPS-Integrated Project Services, Inc. August 2014 - Present
McNeil Consumer Healthcare September 2012 - January 2014
Pharmalink Consulting May 2012 - August 2012
Pfizer (formerly Wyeth) 2002 - 2011
Wyeth Pharmaceuticals 2003 - 2004
Wyeth Pharmaceuticals 2002 - 2003
Systems Solutions, Inc. 1998 - 2002
Skills
Document Management, Regulatory Submissions, Software Documentation, Documentum, Validation, SharePoint, Microsoft Word, Adobe Acrobat, Regulatory Affairs, 21 CFR Part 11, FDA, Visio, Change Control, Pharmaceutical Industry, Graphic Design, Technical Support, eCTD, Training, GMP, Quality Assurance, eRoom, Computer System..., Medical Writing, Project Management, SOP, Clinical Development, Reference, ISI Toolbox, Management, Regulatory Requirements, Pharmacovigilance, Microsoft Word for..., Microsoft Excel, Microsoft SharePoint, Microsoft OneNote, Acrobat Professional..., ISI ToolBox for..., EndNote for scientific..., End-user software..., Innovative Thinking, Innovative business..., Effective solutions, Training and coaching..., PDF, SOP development, Quality by Design, QbD, Pharmaceutical process..., Quality System, cGMP manufacturing
Education
Kutztown University of Pennsylvania 1982 — 1988
Bachelor of Fine Arts, Communication Design
Zumtobel Lighting November 2012 - Present
Pharmalink Consulting 2011 - 2012
Belimo 2006 - 2011
Nice-Pak Products, Inc. 2002 - 2006
Ryder System, Inc. 1990 - 2001
Skills
Employee Relations, Labor Relations, HRIS, Onboarding, Performance Management, Succession Planning, Change Management, FMLA, Deferred Compensation, Talent Management, Employee Benefits, HR Policies, Human Resources, Recruiting, Talent Acquisition, Employee Engagement, Interviews, Employee Training, Sourcing, HR Consulting, Benefits Administration, Personnel Management, Applicant Tracking..., Workforce Planning, College Recruiting, Organizational Design, Employer Branding, Career Development, Technical Recruiting, Employment Law, Benefits Negotiation, Organizational..., Screening, Executive Search, Temporary Placement
Education
Mercy College 1996 — 1998
Masters, Human Resources
Columbia University - Columbia Business School
Executive Coaching Certificate
State University of New York at Geneseo
Bachelors, Geography
Blackrock Pharmaceuticals North America Inc. February 2015 - Present
Third Party Review Group February 2015 - Present
Genpact Pharmalink June 2014 - February 2015
Pharmalink Consulting December 2013 - May 2014
Pharmalink Consulting Inc. September 2007 - December 2013
Pharmalink Consulting 2001 - 2009
Pharmalink Consulting January 2006 - December 2007
Skills
International Business, Strong Business Acumen, Small Business..., Regulatory Affairs, Regulatory Submissions, Pharmaceuticals, Technology Transfer, Clinical Trials, Pharmaceutical Industry, Biopharmaceuticals, Biotechnology, Business Development, CAPA, CTMS, Clinical Development, Cross-functional Team..., FDA, GCP, GMP, Leadership, Management, Medical Devices, Pharmaceutics, Regulatory Requirements, Strategy
Education
Ulster University 1992 — 1994
Masters, Marketing
Queen's University Belfast 1989 — 1992
Bachelor of Arts (Hons), English Literature
... June 2015 - Present
Pharmalink Consulting November 2013 - 2015
SumTotal Systems July 2011 - July 2011
Cybershift Inc. 2008 - 2011
Skills
Business Intelligence, Business Analysis, Financial Reporting, Process Improvement, Business Process..., ERP, Software Documentation, CRM, Vendor Management, Program Management, SharePoint, Management, Team Leadership, Microsoft SQL Server, Enterprise Software
Education
Montclair State University 1988 — 1992
Bachelor of Business Administration (BBA), Accounting
Regulatory Affairs International, LLC (Self-employed) January 2005 - Present
Pharmalink Consulting May 2011 - October 2011
Nektar Therapeutics January 2008 - June 2008
Pfizer August 2004 - December 2007
Chelsea Therapeutics 1985 - 1993
Education
Stony Brook University 1982 — 1985
Master of Science, Pharmaceutical Sciences
Cairo University 1971 — 1975
Bachelor of Science, Food Technology, Microbiology and Chemistry
Pharmalink Consulting September 2012 - Present
Pharmalink Consulting June 2010 - October 2012
Strides Arcolab Limited ( Technology & Research ) May 2004 - May 2009
Cadila Pharmaceuticals March 2002 - March 2004
Skills
GMP, Regulatory Affairs, ANDA, FDA, Regulatory Submissions, Sop, Change Control, Regulatory Requirements, Pharmaceutical Industry, Quality Assurance, Cleaning Validation, CAPA, Pharmaceutics, CMC Regulatory Affairs, Validation, CMC, SOP
Education
Birla Institute of Technology and Science, Pilani 2003 — 2005
M.S., Total Quality Management
Berhampur University 1997 — 2001
B.Pharmacy, Pharmaceutical Sciences
Genpact Pharmalink July 2014 - Present
Pharmalink Consulting March 2012 - July 2014
Merck Animal Health August 2009 - March 2012
Schering-Plough Animal Health January 2008 - August 2008
Montclair State University January 2002 - September 2004
Skills
Regulatory Affairs, Regulatory Submissions, Interpersonal Skills, Pharmaceutical Industry, FDA, Organization Skills, Lifesciences, Pharmacovigilance, Change Control, GLP, Life Sciences, Pharmacology, SOP, Molecular Biology, Clinical Development, GxP, Vaccines, Infectious Diseases, Project Management, CMC Regulatory Affairs, Regulatory Requirements, Data Entry, Virology, EPA, College Teaching, Western Blotting, CMC, Pharmaceuticals, Annual Reports, DER Preparation
Education
University of Medicine and Dentistry of New Jersey 2010 — 2011
Masters of Biomedical Science, Biomedical Science/Pharmacological Science Concentration
Royal Veterinary College, U. of London 2005 — 2008
---, Veterinary Medicine
Montclair State University 2003 — 2005
Bachelors of Science, Biology
Essex County College 2001 — 2003
Associate of Science (A.S.), Biology
Genpact Pharmalink January 2015 - May 2015
Pharmalink Consulting November 2013 - May 2015
Teva Pharmaceuticals October 2012 - July 2013
Teva Pharmaceuticals December 2010 - October 2012
Barr Laboratories December 2007 - December 2010
Kelly Services February 2007 - December 2007
Kelly Services January 2007 - February 2007
Skills
FDA, Regulatory Affairs, Pharmaceutical Industry, Regulatory Requirements, Regulatory Submissions, eCTD, GMP, Change Control, Document Management, Sop, Pharmaceutics, GCP, ANDA, CMC, SOP, CAPA, Validation
Education
University of Phoenix 2013 — 2015
Bachelor of Science in Business
University of Phoenix 2011 — 2013
Associate of Arts, Concentration in Foundations of Business, 3.55 GPA
Rockland Community College 2003 — 2005
Undergraduate studies in Graphic Design
Genpact Pharmalink June 2015 - Present
GENEWIZ February 2015 - May 2015
Pharmalink Consulting June 2013 - January 2015
Counsulting February 2013 - May 2013
Roche Pharmaceuticals April 2010 - February 2013
Roche Pharmaceuticals May 2003 - March 2010
Novartis Oncology 2000 - 2003
Skills
Drug Discovery, Assay Development, High Throughput..., Drug Development, Protein Chemistry, Oncology, Molecular Biology, Biochemistry, Target Identification, Biopharmaceuticals, Enzyme Assays, Cell, Clinical Development, In Vitro, Enzyme Kinetics, Lead Change, Pharmacokinetics, Interaction, Biomarkers, Drug Design, Lead Generation, Medicinal Chemistry, Chemistry, Biomarker Discovery, Pharmacology, Cell Based Assays, Protein Protein..., Fragement Screening, Label-free Technolgoies, Epigenetics, Protein-protein..., Scientific Writing, DMPK, Clinical Trials, Virology, Lead Optimisation, Protein Expression, Medical Writing, Protein Purification, Validation, Toxicology, In Vivo, GCP, Drug Metabolism, Cell Biology, Regulatory Affairs, Immunology, ADME, Translational Research, CMC Regulatory Affairs
Education
Stanford University School of Medicine
Ph.D., Molecular Pharmacology
Cornell University
BS, Biochemistry
Stony Brook University
Biochemistry
Philadelphia Convention & Visitors Bureau July 2015 - Present
Pharmalink Consulting March 2015 - July 2015
Macy's September 2014 - February 2015
Nicole Miller December 2013 - January 2014
XFINITY Live! Philadelphia May 2013 - August 2013
Skills
PowerPoint, InDesign, Illustrator, Photoshop, Social Media, Social Networking, Marketing Communications, Merchandising, Apparel, Microsoft Office, Microsoft Word, Microsoft Excel, Windows
Education
Indiana University of Pennsylvania 2010 — 2014
Bachelor's Degree, Communications Media
California Department of Public Health 2010 - Present
ideja January 2008 - January 2010
Center City District August 2007 - December 2007
Pharmalink Consulting January 2007 - June 2007
United Nations January 2006 - August 2006
Panaceja Pharmacy January 2003 - January 2006
Skills
Market Research, Marketing Strategy, Nonprofits, Research, Community Outreach, Marketing, Business Strategy, Project Management, Strategy, Social Media, Data Analysis, Non-profits, Sustainability, Qualitative Research, Program Management, Public Relations, Marketing Communications, Budgets, Project Planning, Public Speaking, Change Management, Social Media Marketing, Creative Direction, Branding & Identity, Storytelling, Visual Storytelling, Gov 2.0, Content Strategy, Open Government, Global Cross-Functional..., Inspiring People, Technological Innovation, Web 2.0, Citizen Engagement, Sustainable Development, Sustainable Design, Environmental..., Local Government Reform, Civic Engagement, Civic Innovation
Education
Temple University - Fox School of Business and Management 2007 — 2008
MS, Marketing
Temple University - Fox School of Business and Management 2006 — 2007
MBA, International Business
École des Ponts Business School 2006 — 2007
MBA, International Business
California State University-Sacramento 2001 — 2005
BS, Marketing, International Business
Bella Vista Hight School 1999 — 2000
highschool degree
Pharmalink Consulting June 2013 - Present
Plenum Scientific January 2013 - March 2013
Roche June 2005 - 2012
Metabolic Disease/Inflammation June 2001 - June 2005
Novartis Pharmaceuticals July 1992 - June 2001
Novartis 1992 - 2001
Skills
Organic Synthesis, Analytical Chemistry, HPLC, HPLC-MS, NMR spectroscopy, ISIS, Electronic Lab Notebooks, SciFinder, Microsoft Word, PowerPoint, Microsoft Excel, TLC, Scale-up, Multi-step Synthesis, Heterocyclic Chemistry, Chromatography, Lead Change, LC-MS, Purification, In Vivo, NMR, High Throughput..., Drug Design, Drug Discovery, Mass Spectrometry, Medicinal Chemistry, ADME, Drug Development, GLP, Peptides, Assay Development, Biomarkers
Education
Villanova University
M.S, Organic Chemistry
Norwich University
Bachelors of Science, Chemistry
Pharmalink Consulting November 2011 - Present
BRR LTD. CO July 2003 - October 2011
Florida International University May 2008 - August 2009
Pharmaceutics International Inc June 2007 - July 2007
Ethicon January 2006 - December 2006
Lehigh University January 2006 - May 2006
The Kidney Centre Hospital April 2003 - May 2003
First Aid Medical Camp January 2000 - January 2002
Skills
Medical Devices, Biomedical Engineering, Nanotechnology, Product Development, Drug Delivery, Research, Pharmaceutics, R&D, Design of Experiments, FDA, Solidworks, Biotechnology, Matlab, Labview, Biomaterials, Minitab, Engineering, Polymers, Lifesciences, Validation
Education
Florida International University 2007 — 2009
MS, Biomedical Engineering
Lehigh University 2003 — 2007
BS, Bioengineeing
Pfizer April 2015 - Present
Pharmalink Consulting May 2014 - April 2015
Hibbs Landscaping May 2013 - March 2014
Pfizer May 2012 - August 2012
Skills
SQL, HTML, Information Technology, Java, Consulting, C++ Language, XML, Microsoft Office, UML, CSS, Team Leadership, Teamwork, Application Design, Strongly self-motivated, Regulatory Affairs, Software Design, SharePoint, Project Management, Testing, Management Consulting, Change Management, Business Analysis, Visio, Databases, Programming, Troubleshooting, Microsoft Excel
Education
Penn State University 2011 — 2013
Bachelor's degree, Information Technology
Novartis December 2012 - Present
Novartis July 2012 - November 2012
Pharmalink Consulting October 2011 - July 2012
Merck February 2011 - September 2011
Pfizer (Formerly Wyeth) Research January 2001 - January 2011
Wyeth Research June 2000 - October 2009
Analytical Research and Development January 2001 - January 2005
ESI/LEDERLE LABORATORIES January 1997 - January 2001
Skills
Analytical Chemistry, Validation, cGMP, GMP, Regulatory Submissions, HPLC, Pharmaceuticals, UV-Vis
Education
Long Island University 1995 — 1997
Master of Science, Chemistry
Chernovtsy University
BS, Chemistry
Cardinal Health May 2015 - Present
Cardinal Health September 2014 - Present
Self-employed July 2013 - September 2014
Pharmalink Consulting November 2011 - July 2013
Pharmalink Consulting July 2010 - November 2011
GlaxoSmithKline October 2008 - July 2010
Alphapharm Pty Ltd. May 2006 - January 2008
AstraZeneca, Australia January 2004 - April 2006
Pfizer, Australia 2002 - 2004
Leiner Health Products, SC USA January 1999 - March 2001
Skills
CMC, CTD, MAA, FDA, cGMP, eCTD, IND, ANDA, CPP, TGA, Regulatory Affairs, Medical Devices, Pharmaceuticals, SOP, Validation, Pharmaceutical Industry, GMP, Regulatory Submissions, Regulatory Requirements, CMC Regulatory Affairs, Change Control, Pharmaceutics, 21 CFR Part 11, Regulations, ICH guidelines, Regulatory Guidelines, Regulatory Documentation, Dossier Preparation, ISO 13485, Pharmacovigilance, NDA, GxP, CAPA, Drug Development, GLP, Clinical Development, GCP, Biopharmaceuticals, Clinical Trials, Technology Transfer
Education
University of Sydney 2001 — 2002
Grad Dipl., Pharmaceutical Science
University of North Carolina at Charlotte 1995 — 1998
B.Sc., Biology
Campbell University 1994 — 1995
Pre-pharmacy
Catalent Pharma Solutions May 2012 - July 2015
Rutgers Business School 2014 - 2015
Pharmalink Consulting April 2012 - May 2012
Pfizer July 2006 - October 2011
LTS Lohmann Therapy Systems, NJ and Pharmascience, Montreal 2004 - 2006
Skills
Pharmaceutical Industry, Pharmaceutics, Regulatory Affairs, Technology Transfer, Validation, Drug Development, Pharmaceutical Research, Product Development, Pharmaceutical..., Project Management, Generics
Education
Rutgers, The State University of New Jersey - Rutgers Business School
Master of Business Administration (MBA)
University of Manitoba
PhD, Pharmaceutical Sciences
Genpact Pharmalink October 2014 - Present
PharmalinkConsulting September 2013 - Present
Pharmalink Consulting October 2012 - Present
Pharmalink Consulting July 2011 - September 2012
Catalent Pharma Solutions (formerly known as Cardinal Health) November 2004 - February 2011
VistaPharm, Inc 2002 - 2004
Bausch + Lomb 2001 - 2002
UDL Laboratories, a division of Mylan Pharmaceuticals 1993 - 2001
Skills
Regulatory Affairs, FDA, Regulatory Requirements, Regulatory Submissions, CMC, Pharmaceutics, Regulations, Strategy, CAPA, V&V, Change Control, GMP, GxP, Pharmaceutical Industry, GLP, ANDA, Generic Programming, Technology Transfer, Sop, Validation, IND, Biopharmaceuticals, Quality System, Quality Assurance, eCTD, Clinical Trials, Computer System..., 21 CFR Part 11, Drug Development
Education
A class taught by you!
St. Petersburg College
Accenture September 2010 - Present
Accenture March 2010 - September 2010
Pharmalink Consulting September 2009 - November 2009
Kelly Scientific Resources December 1998 - September 2009
Wyeth December 1998 - March 2001
Lundbeck Research USA, fka Synaptic Pharmaceutical Corp. 1995 - 1998
Aqua Pro-Tech Services 1994 - 1996
Bergen Regional Medical Center 1990 - 1994
Skills
Talent Acquisition, Sourcing, Organizational..., Coaching, Sales Recruitment, Corporate Recruiting, Executive Sales..., Onboarding, Recruiting, Human Resources, Interviews, Employee Relations, Change Management, Temporary Placement, Talent Management, Management Consulting, Technical Recruiting, Training, Management, Personnel Management, Internet Recruiting, Strategy, Leadership, Strategic Planning, CRM, Staffing Services, Applicant Tracking..., New Business Development, Sales, Consulting
Education
Binghamton University 1972 — 1976
BA, Biology
Saint John's University 1981 — 1984
MS, Toxicology
Fairleigh Dickinson University 1999 — 2000
PHR, Professional in Human Resources
Genpact Pharmalink January 2013 - Present
Pharmalink Consulting January 2012 - December 2012
Pharmalink Consulting November 2009 - December 2011
Schering-Plough Research Institute July 2008 - November 2009
Suburban Physical Therapy 2004 - 2008
Skills
eCTD, Regulatory Affairs, Regulatory Submissions, Clinical Data Management, CMC Regulatory Affairs, Standards Compliance, FDA, GMP, Pharmaceutical Industry, Regulatory Requirements, SOP, Sop, Clinical Development, GLP, GCP, Biotechnology
Education
University of Medicine and Dentistry of New Jersey 2011 — 2014
MS, Clinical Trial Sciences, Concentration in Regulatory Affairs
William Paterson University of New Jersey 2003 — 2008
BS, Biology
Tri County Orthopedic Surgeons October 2014 - March 2015
Genpact Pharmalink December 2011 - November 2014
Merck November 2010 - December 2011
Pharmalink Consulting June 2010 - November 2010
Wyeth Consumer Healthcare August 2008 - December 2009
Education
Boston University School of Medicine 2015 — 2017
Master's Degree, Physician Assistant, PA-S1
Rutgers, The State University of New Jersey-New Brunswick 2004 — 2008
BS, Biological Sciences
AbbVie June 2014 - Present
Pharmalink Consulting June 2013 - June 2014
Johns Hopkins University Press August 2012 - August 2013
Cranium Lifesciences December 2010 - June 2011
NHS June 2010 - September 2010
University of Warwick June 2009 - September 2009
International Journal of Bioinformatics February 2009 - June 2009
Padmashree Dr. D.Y Patil University,Navi Mumbai January 2009 - June 2009
Skills
Regulatory Affairs, Regulatory Submissions, Regulatory Requirements, Regulations, cGMP practices, Quality System, Clinical Research, Clinical Trials, Research, Document Management, Technical Documentation, Project Management, Marketing, Marketing Strategy, Consulting, IT Management, Clinical Pharmacology, Data Analysis, Data Entry, Data Warehousing, Data Management, EHR, Microsoft Office, SQL, Public Speaking, Time Management, Online Research, Biotechnology, Lifesciences, Molecular Biology, GMP, Statistics, Sop, Pharmaceutical Industry, Cell Culture, HPLC, Western Blotting, Biostatistics, Market Research, FDA, Drug Development, Vaccines, Life Sciences
Education
The Johns Hopkins University 2011 — 2013
Bioscience Regulatory Affairs, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs, 3.7 on 4
University of Warwick 2009 — 2011
Biotechnology, Bioprocessing and Business Management, Biotechnology and Business Management, 3.4 on 4
Dr. D.Y. Patil University 2005 — 2009
Bioinformatics, Biotechnology, Bioinformatics, and Computational Biology, 3.3 on 4
nVie Enersaage January 2014 - Present
Pactera 2011 - 2013
BTI Group Mergers & Acquisitions 2008 - 2011
Pharmalink Consulting January 2007 - June 2007
du PARC & Associé March 2004 - September 2006
Auditis Audit & Consulting September 2004 - August 2006
QianFeng Electronic Co.Ltd June 2004 - August 2004
Skills
Mergers & Acquisitions, Financial analysis, Financial modeling, Strategic Planning, Team building, Projection & Budgeting, Quantitative analysis, Risk analysis, Quantitative Analytics, Mergers, Financial Modeling, Financial Analysis, Budgets, Business Valuation, Team Building, Finance, Strategy, Valuation, Business Planning, Corporate Development, Business Strategy, Leadership, Due Diligence, Investments, Risk Management
Education
Temple University - Fox School of Business and Management 2007 — 2008
MBA, Finance
ENPC MBA Paris - ENPC School of International Management 2006 — 2007
MBA, International Management
Université de Bourgogne 2003 — 2006
Bachelor, Corporate Law & Psychology
ChongQing Foreign Languages School 1998 — 2001
High School, Science
Precision for Value January 2015 - Present
Tiffany & Co. May 2014 - November 2014
Pharmalink Consulting November 2013 - May 2014
Integra LifeSciences September 2013 - October 2013
Toys R Us April 2011 - August 2013
Novartis Pharmaceuticals - Contract Recruiter April 2010 - April 2011
Kraft Foods July 2007 - 2010
Various Positions 1999 - 2007
Nabisco 1995 - 1998
Liz Claiborne 1993 - 1995
Skills
Executive Search, Applicant Tracking..., College Recruiting, Internet Recruiting, Direct Sourcing, Social Networking, Human Resources, Employer Branding, Recruiting, Temporary Placement, Networking, Cross-functional Team..., Time Management, Technical Recruiting, Interviews, Talent Acquisition, Sourcing, Taleo, Employment Law, Cold Calling, HR Policies, Employee Relations, Negotiation, Screening, Contract Recruitment, Leadership, Staffing Services, Hiring, Policy, E-commerce, Screening Resumes, Employee Benefits, Consulting, Lead Generation, Payroll, Strategy, Project Planning, Job Fairs, Analysis, Temporary Staffing, Job Descriptions, Performance Management, Talent Management, Personnel Management, Succession Planning, CRM, Management, Benefits Negotiation, SDLC, Workforce Planning
Education
Cornell ILR program at Baruch College 1992 — 1993
Industrial Labor Relations
Hofstra University
Bachelor's Degree, Business Administration
State University of New York at Binghamton
Liberal Arts
PAREXEL July 2014 - Present
Pharmalink Consulting May 2012 - Present
Merck September 2009 - May 2012
PPD October 2007 - September 2009
Centocor October 2003 - October 2007
American Red Cross, Southeastern Pennsylvania Chapter November 2001 - October 2003
Temple University Hospital September 1996 - May 1997
Skills
HPLC, Biopharmaceuticals, Pharmaceutical Industry, GLP, GMP, Sop, Regulatory Affairs, Analytical Chemistry, ELISA, Validation, Biotechnology, Lifesciences, FDA, Bioanalysis, Method Transfer, V&V, Change Control, Regulatory Submissions
Education
Lincoln University 1996 — 2001
Bachelor of Arts (B.A.), Biology, General
The FDA Group, LLC May 2014 - Present
Apothaceutics International, Inc April 2006 - Present
Apothaceutics International, Inc. April 2006 - Present
Optum Global Solutions.mapi Group thriough Raland Complioaence Partners November 2014 - June 2015
Sarepta Therapeutics through BioBridges August 2014 - October 2014
Merck through NewAge Systems February 2013 - August 2013
Ipsen thru ClinLab Staffing November 2012 - December 2012
Novartis Consumer Health/Oxford Global Resources October 2011 - October 2012
Pharmalink Consulting June 2010 - April 2011
Regeneron Pharmaceuticals, Inc. 2008 - 2009
Skills
Regulatory sbmisssions..., Regulatory submisions..., Magazine article..., Qaulity systems..., Investigations and..., Batch record reviews..., Gap analyes (analytical..., CAPA, Analytical methods..., SOP writing, IND, Writing, Pharmaceuticals, cGMP, Quality Systems, HPLC, Change Control, Chemistry, Regulatory Submissions, Analytical Chemistry, Medical Writing, Validation, Pharmaceutical Industry, Sop, Analytical Skills, GMP, Analytical Methods..., Medical Devices, Quality System, Software Documentation, Regulatory Affairs, FDA, CMC, Clinical Research, Quality Assurance, GLP, Drug Development, Drug Discovery, Pharmaceutics, Quality Control, Biotechnology, Biopharmaceuticals, Technology Transfer, V&V, Lifesciences, R&D, Oncology, Clinical Trials, NDA, GxP
Education
New York University - Polytechnic School of Engineering 1982 — 1985
MS
Binghamton University 1977 — 1980
MA
Clarkson University 1973 — 1977
Ave Maria School of Law August 2014 - Present
Cleveland Clinic November 2011 - June 2014
Cleveland Metropolitan School District August 2008 - November 2011
Advanstar Communications July 2011 - September 2011
Shaker Heights School District August 2009 - September 2011
Black Professionals Association Charitable Foundation July 2010 - October 2010
Oglesby Consulting January 2008 - 2010
Pharmalink Consulting January 2007 - May 2007
Litigation Management/Medicine for the Defense February 2006 - July 2006
The University of South Dakota August 2003 - December 2004
Skills
Project Management, Project Planning, Project Coordination, Event Planning, Customer Relations, Planning, Contract Negotiation, Public Relations, Coordination, Research, Writing, Strategic Planning, Event Management, Marketing Strategy, Promotions, Media Relations, Microsoft Office, Customer Service, Market Research, Teaching, Editing, PowerPoint, Word, Social Media Marketing, Problem Solving, Marketing Communications, Press Releases, Online Marketing, Program Development, Community Relations, Microsoft Word, Administrative Work, Building Relationships, Blogging, Public Speaking, Program Management, Community Outreach, Advertising, Budgets, Corporate Communications, Policy
Education
Baldwin Wallace University 2013 — 2013
Certificate, Project Management
Employment Connection REACH To Lead Leadership Workshop 2011 — 2011
Certificate, Leadership Workshop: Healthcare Careers Initiative (HCI)
Temple University - Fox School of Business and Management 2006 — 2008
MBA, International Business
Ecole nationale des Ponts et Chaussées 2006 — 2006
MBA, International Business
The University of South Dakota School of Law 2002 — 2005
JD, Law
Northwood University
BBA, Marketing/Management
Virginia Marti School of Art & Design
Associates, Fashion Merchandising & Business
Genpact Pharmalink August 2014 - Present
Pharmalink Consulting January 2012 - August 2014
Pfizer October 2009 - October 2011
Wyeth February 2008 - October 2009
Wyeth Consumer Healthcare 2005 - 2008
Skills
CMC, Pharmaceutical Industry, Regulatory Submissions, Regulatory Affairs, IND, GMP, Change Control, FDA, 21 CFR Part 11, Clinical Development, Validation, Sop
Education
Polytechnic University
Master of Science (M.S.), Computer Science
Union College
Bachelor of Science (B.S.), Chemistry
Hepregen Corporation November 2014 - Present
Hepregen Corporation January 2014 - October 2014
Pharmalink Consulting 2010 - 2013
Pfizer 2005 - 2010
Education
Northeastern University
Master's degree in progress
University of New Hampshire
Bachelor's degree, Microbiology
Aegerion Pharmaceuticals June 2015 - Present
Avedro, Inc. July 2014 - May 2015
Fresenius Medical Care April 2011 - July 2014
Bausch & Lomb October 2010 - April 2011
Pharmalink Consulting June 2009 - October 2010
Emisphere Technologies August 2006 - December 2008
Skills
Strategy, Regulatory Affairs, R&D, FDA, Biopharmaceuticals, Pharmaceutical Industry, CMC, Biologics, Quality Assurance, Regulatory Submissions, IND, Biochemistry, CAPA, Chemistry, Regulatory Requirements, Pharmaceutics, ISO 13485, GLP, GMP, Analytical Chemistry, Biotechnology, Management, Regulations, Sop, Clinical Trials
Education
Nanjing University
Bachelor's degree
University of Illinois at Chicago
Doctor of Philosophy (Ph.D.)
Carl Zeiss Meditec October 2013 - March 2014
CooperVision May 2013 - September 2013
Pharmalink Consulting July 2011 - January 2013
Mutchler Inc.Pharmaceuticals Ingredients June 2010 - May 2011
Long Island University January 2008 - December 2009
Nicholas Piramal India Limited, India 2007 - 2008
Ranbaxy 2005 - 2007
Skills
Negotiation, Creative Visualization, Regulatory Affairs, Regulatory Requirements, ANDA, eCTD, Analytical Skills, Regulatory Submissions, FDA, Sop, GMP, Pharmaceutical Industry, Pharmacovigilance, 21 CFR Part 11, GLP, Clinical Trials, Validation, CAPA, V&V, GCP
Education
LIU Brooklyn 2008 — 2010
MS, Drug Regulatory Affairs
Long Island University 2008 — 2009
Master's, Drug Regulatory Affairs
SGSITS
Pharmalink Consulting November 2013 - August 2014
Johnson & Johnson April 2001 - February 2009
American Express November 1998 - April 2001
Pepsi Bottling Group November 1993 - November 1998
Skills
Talent Management, Deferred Compensation, Workforce Planning, Succession Planning, Leadership Development, Onboarding, Human Resources, Employee Engagement, Organizational Design, HRIS, Talent Acquisition, Performance Management, Organizational..., Employee Relations, HR Policies, Organizational..., HR Consulting, HR Transformation, Career Development, Change Management, Job Analysis, Performance Improvement, Mergers, Compensation, Compensation, Leadership, Pharmaceutical Industry, Employee Benefits
Education
University of Rhode Island 1989 — 1993
BA, Psychology
New Fairfield High School 1985 — 1989
Novo Nordisk April 2014 - Present
Novo Nordisk October 2013 - April 2014
Ranbaxy October 2012 - October 2013
Pharmalink Consulting 2012 - October 2012
Colgate Palmolive October 2009 - April 2012
NYU Langone Medical January 2009 - March 2009
GENEWIZ July 2008 - October 2008
UMDNJ August 2007 - July 2008
Skills
Regulatory Affairs, Regulatory Submissions, Clinical Research, Scientists, Business, eCTD, DMF, ANDAs, IND, ISI Toolbox, Change Control, Intellectual Property, ELISA, Pharmaceutical Industry, Cell Culture
Education
Rutgers, The State University of New Jersey - Rutgers Business School 2011 — 2012
Master of Business & Science (MBS), Life Sciences & Healthcare Concentration, Drug Discovery and Developement
Rutgers University 2006 — 2008
Bachelors of Science, Biological Sciences(neuroscience) and Biochemistry
Middlesex County College
Associate's, Biology
Stryker March 2015 - July 2015
Pharmalink Consulting June 2013 - March 2015
LifeCell Corporation June 2011 - June 2013
Merck August 2010 - May 2011
Merck January 2010 - July 2010
Skills
FDA, Validation, Pharmaceutical Industry, Clinical Trials, Clinical Research, Regulatory Affairs, LIMS, GLP, GMP, ICH-GCP, GTP, Medical Devices, Drug Development, Clinical Development, ISO 13485, Quality System..., Regulatory Submissions, IND, NDA, Annual Reports, BLA, IDE, PMAs, 510(k), GDP, USP, Quality Control, Eager to learn new...
Education
Northeastern University 2012 — 2013
Master Of Science, Regulatory Affairs
Rutgers University
Bachelor of Science, Biology
Genpact Pharmalink November 2014 - Present
Pharmalink Consulting September 2012 - Present
Pfizer April 2011 - September 2012
Pfizer (acquired Wyeth, October 2009) June 2008 - April 2011
Wyeth Pharmaceuticals May 2005 - May 2008
Pfizer January 2004 - May 2005
Pfizer March 2003 - December 2004
GlaxoSmithKline January 1999 - February 2003
SmithKline Beecham Pkarmaceuticals August 1996 - January 1999
SmithKline Beecham Pharmaceuticals January 1992 - December 1996
Skills
Regulatory Requirements, Regulatory Affairs, cGMP, GxP, Pharmaceuticals, GMP, Pharmaceutical Industry, Validation, Change Control, 21 CFR Part 11, Aseptic Processing, CMC, CAPA, Compliance, Document Management, Drug Discovery, FDA, Internal Audit, Manufacturing, Pharmaceutics, Quality Assurance, Quality Auditing, Quality by Design, Software Documentation, Trackwise, eCTD, FDA GMP, ANDA, CMC Regulatory Affairs, NDA, Quality System, Drug Development, IND, ISO 13485, Product Development, Quality Control, Sop, Technology Transfer, TrackWise, SOP, Lifesciences, Computer System...
Education
Universidad de Puerto Rico
Bachelor's degree, Natural Sciences
Boehringer Ingelheim August 2013 - Present
Teva Pharmaceuticals February 2012 - August 2013
Cardinal Health June 2011 - February 2012
Pharmalink Consulting June 2010 - June 2011
ARMGO Pharma, Inc. 2007 - 2010
Penwest Pharmaceuticals 2004 - 2007
ATON Pharma, Inc. 2002 - 2004
Halsey Pharmaceuticals 2000 - 2002
Taro Pharmaceuticals 1997 - 2000
Skills
FDA, IND, Pharmaceutical Industry, CMC, Medical Devices, Generic Programming, Regulatory Affairs, Regulatory Submissions, eCTD, Sop, GMP, Regulatory Requirements, GLP, Drug Discovery, CAPA, CRO, Quality System, Analytical Chemistry, Change Control, Validation, Pharmaceutics, HPLC, Drug Development, SOP
Education
LIU Brooklyn
M.S., Pharmaceutics
Stony Brook University
B.S., Chemistry
Cardinal Health December 2012 - Present
Pharmalink Consulting February 2011 - November 2012
Pfizer October 2009 - June 2010
Wyeth Research June 2005 - September 2009
Wyeth Research January 2003 - May 2005
Wyeth Research November 2001 - December 2002
Skills
GMP, Pharmaceutical Industry
Education
Московская Государственная Академия Тонкой Химической Технологии им. М.В.Ломоносова (МИТХТ)
Ph. D., Organic Chemistry