Pharmalink Consulting

Industry: Company

Description

Pharmalink 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

Employee
Years
Job
Industry
Robert Mercogliano Robert Mercogliano Greater New York City Area Details
Robert Mercogliano's Pharmalink Consulting Experience December 2013 - July 2015
Job Medical Devices
Industry Medical Devices
Experience
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

Nikki Harper Nikki Harper Greater Philadelphia Area Details
Nikki Harper's Pharmalink Consulting Experience March 2012 - September 2012
Job Regulatory Consultant at Pyxa Solutions.
Industry Pharmaceuticals
Experience
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

Heather Rae Hufnagel Heather Rae Hufnagel Greater Philadelphia Area Details
Heather Rae Hufnagel's Pharmalink Consulting Experience January 2012 - July 2012
Job Senior Project Manager PPD
Industry Pharmaceuticals
Experience
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

Edward Rodrigo Edward Rodrigo Greater Philadelphia Area Details
Edward Rodrigo's Pharmalink Consulting Experience May 2012 - August 2012
Job Senior Validation Specialist at IPSIntegrated Project Services, Inc.
Industry Pharmaceuticals
Experience
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

Cindy Gerathy Cindy Gerathy Greater New York City Area Details
Cindy Gerathy's Pharmalink Consulting Experience 2011 - 2012
Job Human Resources Director
Industry Human Resources
Experience
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

Stephen Loughrey Stephen Loughrey Greater New York City Area Details
Stephen Loughrey's Pharmalink Consulting Experience December 2013 - May 2014
Job Chief Executive Officer
Industry Pharmaceuticals
Experience
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

Laura Biggio Laura Biggio Greater New York City Area Details
Laura Biggio's Pharmalink Consulting Experience November 2013 - 2015
Job Accounting Manager
Industry Accounting
Experience
...   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

Soheil Michel El-khal Soheil Michel El-khal Kalamazoo, Michigan Area Details
Soheil Michel El-khal's Pharmalink Consulting Experience May 2011 - October 2011
Job Consultant at Regulatory Affairs International, LLC
Industry Pharmaceuticals
Experience
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

Susmita Saumya Darshinee Susmita Saumya Darshinee Greater New York City Area Details
Susmita Saumya Darshinee's Pharmalink Consulting Experience September 2012 - Present
Job CMC Strategist at Pharmalink Consulting
Industry Pharmaceuticals
Experience
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

Claudia Batson, PMP, MBS Claudia Batson, PMP, MBS Newark, New Jersey Details
Claudia Batson, PMP, MBS's Pharmalink Consulting Experience March 2012 - July 2014
Job Regulatory Affairs Manager at Genpact Pharmalink
Industry Pharmaceuticals
Experience
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

Daniel Peer Daniel Peer Moosup, Connecticut Details
Daniel Peer's Pharmalink Consulting Experience November 2013 - May 2015
Job Hub Submission Manager/Dossier Coordinator currently seeking new opportunities
Industry Pharmaceuticals
Experience
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

Lin Gao Lin Gao Greater New York City Area Details
Lin Gao's Pharmalink Consulting Experience June 2013 - January 2015
Job Regulatory Affairs Manager | Sr. Principal Scientist
Industry Pharmaceuticals
Experience
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

Francesca Mascino Francesca Mascino Langhorne, Pennsylvania Details
Francesca Mascino's Pharmalink Consulting Experience March 2015 - July 2015
Job Convention Sales Coordinator at Philadelphia Convention & Visitors Bureau
Industry Marketing and Advertising
Experience
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

Tamara Srzentic Tamara Srzentic Sacramento, California Area Details
Tamara Srzentic's Pharmalink Consulting Experience January 2007 - June 2007
Job Communications Director & OpenGov Evangelist
Industry Government Relations
Experience
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

Nicholas Marcopulos Nicholas Marcopulos Greater New York City Area Details
Nicholas Marcopulos's Pharmalink Consulting Experience June 2013 - Present
Job Pharmaceutical Professional Regulatory Affairs Consultant at Pharmalink
Industry Pharmaceuticals
Experience
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

Syed Zahid Kazmi Syed Zahid Kazmi Short Hills, New Jersey Details
Syed Zahid Kazmi's Pharmalink Consulting Experience November 2011 - Present
Job Regulatory Affairs Associate at Pharmalink Consulting
Industry Pharmaceuticals
Experience
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

Jared Hibbs Jared Hibbs Pottstown, Pennsylvania Details
Jared Hibbs's Pharmalink Consulting Experience May 2014 - April 2015
Job Product License Support Manager at Pfizer
Industry Management Consulting
Experience
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

Irina Vertsman Irina Vertsman Greater New York City Area Details
Irina Vertsman's Pharmalink Consulting Experience October 2011 - July 2012
Job Regulatory CMC Manager at Novartis
Industry Pharmaceuticals
Experience
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

Harun Sinha Harun Sinha Greater New York City Area Details
Harun Sinha's Pharmalink Consulting Experience November 2011 - July 2013
Job Manager, CMC, Regulatory Sciences at Cardinal Health
Industry Pharmaceuticals
Experience
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

Vikram Sarveiya Vikram Sarveiya Greater New York City Area Details
Vikram Sarveiya's Pharmalink Consulting Experience April 2012 - May 2012
Job Manager at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
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

Gloria Kulcheski Gloria Kulcheski Clearwater, Florida Details
Gloria Kulcheski's Pharmalink Consulting Experience October 2012 - Present
Job Assistant Vice President, Regulatory Affairs at Genpact Pharmalink
Industry Pharmaceuticals
Experience
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

Joanne Peters Joanne Peters Greater New York City Area Details
Joanne Peters's Pharmalink Consulting Experience September 2009 - November 2009
Job Talent Acquisition Specialist at Accenture
Industry Staffing and Recruiting
Experience
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

Samantha Chalkley Samantha Chalkley Greater New York City Area Details
Samantha Chalkley's Pharmalink Consulting Experience January 2012 - December 2012
Job Regulatory Affairs Manager at Genpact Pharmalink
Industry Pharmaceuticals
Experience
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

Andrew DeVoid Andrew DeVoid Greater New York City Area Details
Andrew DeVoid's Pharmalink Consulting Experience June 2010 - November 2010
Job Physician Assistant Student Boston University School of Medicine
Industry Medical Practice
Experience
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

Anish Phadnis Anish Phadnis Baltimore, Maryland Details
Anish Phadnis's Pharmalink Consulting Experience June 2013 - June 2014
Job Regulatory Affairs Associate
Industry Pharmaceuticals
Experience
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

Sally Shuai Sally Shuai San Francisco Bay Area Details
Sally Shuai's Pharmalink Consulting Experience January 2007 - June 2007
Job CoFounder & Lead Trainer at nVie Enersaage
Industry Health, Wellness and Fitness
Experience
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

Stacy L. (Turner) Blackman Stacy L. (Turner) Blackman Greater New York City Area Details
Stacy L. (Turner) Blackman's Pharmalink Consulting Experience November 2013 - May 2014
Job Talent Acquisition Specialist at Precision For Value
Industry Human Resources
Experience
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

Jeanine C Avery Jeanine C Avery Philadelphia, Pennsylvania Details
Jeanine C Avery's Pharmalink Consulting Experience May 2012 - Present
Job Regulatory Consultant at PAREXEL
Industry Pharmaceuticals
Experience
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

Mark D. Weiss Mark D. Weiss Greater New York City Area Details
Mark D. Weiss's Pharmalink Consulting Experience June 2010 - April 2011
Job
Industry Pharmaceuticals
Experience
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

Celestine Oglesby, JD, MBA Celestine Oglesby, JD, MBA Naples, Florida Details
Celestine Oglesby, JD, MBA's Pharmalink Consulting Experience January 2007 - May 2007
Job Assistant Director Career Services Law School
Industry Education Management
Experience
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

Patricia Thorman Patricia Thorman Greater New York City Area Details
Patricia Thorman's Pharmalink Consulting Experience January 2012 - August 2014
Job Vice President at Genpact Pharmalink
Industry Pharmaceuticals
Experience
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

Judith Harrington Judith Harrington Greater Boston Area Details
Judith Harrington's Pharmalink Consulting Experience 2010 - 2013
Job Associate Director, Quality Assurance at Hepregen Corporation
Industry Pharmaceuticals
Experience
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

Dahua (Daniel) Pan Dahua (Daniel) Pan Greater Boston Area Details
Dahua (Daniel) Pan's Pharmalink Consulting Experience June 2009 - October 2010
Job Regulatory Affairs Manager at Aegerion Pharmaceuticals
Industry Pharmaceuticals
Experience
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.)

Jinali Bhavsar MS,RAC-US Jinali Bhavsar MS,RAC-US San Francisco Bay Area Details
Jinali Bhavsar MS,RAC-US's Pharmalink Consulting Experience July 2011 - January 2013
Job Regulatory Affairs Specialist at Carl Zeiss Meditec
Industry Medical Devices
Experience
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

Joanne (Francis) Reilly Joanne (Francis) Reilly Greater New York City Area Details
Joanne (Francis) Reilly's Pharmalink Consulting Experience November 2013 - August 2014
Job Director Human Resources at Pharmalink Consulting
Industry Pharmaceuticals
Experience
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

Aditi Shah Aditi Shah Greater New York City Area Details
Aditi Shah's Pharmalink Consulting Experience 2012 - October 2012
Job Senior Regulatory Affairs Associate at Novo Nordisk
Industry Biotechnology
Experience
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

Nikin Desai Nikin Desai Greater New York City Area Details
Nikin Desai's Pharmalink Consulting Experience June 2013 - March 2015
Job Regulatory Affairs Associate at Stryker
Industry Pharmaceuticals
Experience
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

Sol Colon Sol Colon United States Details
Sol Colon's Pharmalink Consulting Experience September 2012 - Present
Job Assistant Vice President Regulatory Affairs at Genpact Pharmalink
Industry Pharmaceuticals
Experience
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

Lorraine Sachs Lorraine Sachs Greater New York City Area Details
Lorraine Sachs's Pharmalink Consulting Experience June 2010 - June 2011
Job Associate Director Regulatory Affairs at Boehringer Ingelheim
Industry Pharmaceuticals
Experience
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

Tatiana Anikina Tatiana Anikina Greater Philadelphia Area Details
Tatiana Anikina's Pharmalink Consulting Experience February 2011 - November 2012
Job Senior Regulatory Affairs Consultant at Cardinal Health
Industry Pharmaceuticals
Experience
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

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