Genpact Pharmalink

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: Genpact

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Genpact Pharmalink Employees

Employee
Years
Job
Industry
Birju Patel, MS, RAC Birju Patel, MS, RAC Greater New York City Area Details
Birju Patel, MS, RAC's Genpact Pharmalink Experience June 2013 - December 2014
Job Regulatory Affairs CMC Consultant
Industry Pharmaceuticals
Experience
Genpact Pharmalink   June 2013 - December 2014
Unigene Laboratories, Inc.   January 2012 - June 2013
Unigene Laboratories, Inc.   June 2011 - June 2013
Unigene Laboratories Inc  March 2008 - June 2011
International Trading Pharmaceutical Laboratories   December 2005 - December 2007

Skills
FDA Regulations, ICH Guidelines, cGMP Compliance, HPLC Assays, Dissolution Method..., MS Office Suite, ANOVA, GMP, FDA, Wet Chemistry, HPLC, Assay Development, Dissolution, Validation, Pharmaceutical Industry, ICH guidelines, Biopharmaceuticals, GLP, Sop, Microsoft Office, Regulatory Affairs, Analytical Chemistry, Quality Control, Pharmaceutics, UV/Vis, Quality Assurance, Quality System, SOP

Education
Northeastern University   2010 — 2011
Masters, Drugs, Biologics, and Medical Device Regulatory Affairs

Rutgers University-New Brunswick   2000 — 2005
Bachelors, Cell Biology and Neuroscience

Juan Alcazar Juan Alcazar Puerto Rico area Details
Juan Alcazar's Genpact Pharmalink Experience March 2014 - Present
Job Regulatory Affairs Consultant
Industry Pharmaceuticals
Experience
Genpact Pharmalink   March 2014 - Present
New Heaven Reef Conservation Program   2013 - 2013
Pfizer  June 2003 - December 2012
Schering Plough Products LLC. Manati, Puerto Rico   November 2002 - June 2003
Schering Plough Products LLC. Manati, Puerto Rico   July 2001 - November 2002
Ortho-McNeil Pharmaceutical. Manati, Puerto Rico   March 2000 - September 2000

Skills
Change Management, Quality System, Regulatory Affairs, Change Control, Trackwise, SAP, Microsoft Office, Metrics, 21 CFR Part 11, GMP, FDA, Pharmaceutical Industry, GxP, Aseptic Processing, Analytical Chemistry, Auditing, Biopharmaceuticals, Biotechnology, CAPA, Chromatography, Cleaning Validation, Clinical Trials, Computer System..., Continuous Improvement, Cross-functional Team..., Document Management, FDA GMP, Manufacturing, Microbiology, Pharmaceutics, Quality Assurance, Quality Auditing, Quality Control, Quality Management, Regulatory Requirements, Regulatory Submissions, Root Cause Analysis, SOP, Six Sigma, Software Documentation, Sop, Technology Transfer, TrackWise, Testing, Validation

Education
Seminario Evangelico de Puerto Rico   2006 — 2010
Master's degree, Arts and Religion

University of Puerto Rico   1993 — 1999
Bachelor, Natural Sciences, Major in Biology

Igor Grachev, MD, PhD Igor Grachev, MD, PhD Parsippany, New Jersey Details
Igor Grachev, MD, PhD's Genpact Pharmalink Experience June 2014 - October 2014
Job New Growth Franchise Global Head, Clinical, Medical and Drug Safety, GSK (Formally Novartis)
Industry Pharmaceuticals
Experience
GSK  October 2014 - Present
International Journal of Neurology and Brain Disorders   February 2015 - Present
Novartis Consumer Health  June 2014 - October 2014
Genpact Pharmalink   June 2014 - October 2014
GE Healthcare  March 2012 - May 2014
GE Healthcare  March 2010 - March 2012
Dr. Grachev, MD, PhD Pharmaceutical Consulting   June 2009 - March 2010
Schering-Plough Research Institute  July 2009 - December 2009
BioClinica  August 2008 - June 2009
Merck & Co., Inc.   May 2007 - August 2008

Skills
Clinical Development, Clinical Trials, Oncology, Pharmaceutical Industry, Clinical Research, Biotechnology, CRO, Drug Development, Regulatory Submissions, Medical Affairs, Neurology, Pharmacology, Medical Devices, FDA, Neuroscience, Pharmacovigilance, Life Sciences, Biomarkers, Immunology, Regulatory Affairs, Commercialization, R&D, GCP, Medicine, Healthcare, Cross-functional Team..., Cardiology, Pharmaceutics, Translational Medicine, Infectious Diseases, Clinical Study Design, Therapeutic areas, Dermatology, Strategic Planning, Product Development, Translational Research, Diagnostics, Ophthalmology, Therapeutic Areas, Clinical Pharmacology

Education
Harvard Medical School

Harvard Medical School

National Medical Academy of Postgraduate Education (Shupyk)
Doctor of Philosophy (Ph.D.)

National Medical University 'O.O. Bogomolec'
M.D. with Highest Honor

National Medical Academy of Postgraduate Education (Shupyk)

Institute of Gerontology of the National Academy of Sciences

National Medical University 'O.O. Bogomolec'
Internship in Internal Medicine

Essen University Hospital, Germany

Menterschwaige Hospital, Munich, Germany

Stephen Loughrey Stephen Loughrey Greater New York City Area Details
Stephen Loughrey's Genpact Pharmalink Experience June 2014 - February 2015
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

Jim Bonner Jim Bonner Greater Philadelphia Area Details
Jim Bonner's Genpact Pharmalink Experience 2014 - April 2015
Job Sr. Principal Engineer at Shire Pharmaceuticals
Industry Pharmaceuticals
Experience
Shire Pharmaceuticals  April 2015 - Present
The One When Pharm Services LLC   August 2010 - Present
Genpact Pharmalink   2014 - April 2015
Merck  2006 - 2010
Merck  2003 - 2006
Merck  1990 - 2003
General Motors  1986 - 1988

Skills
Technology Transfer, Process Improvement, Due Diligence, International Project..., cGMP, Contract Manufacturing, Six Sigma, Engineering, Process Validation, GMP, Validation, Process Optimization, Pharmaceuticals, API, SOP, CAPA, Quality Systems, Process Development, Manufacturing, Lean Manufacturing, Cross-functional Team..., Process Engineering, Compliance, Process Simulation, Formulation, Sop, Commercialization, Quality System, Operational Excellence, Pharmaceutical Industry, V&V, Regulatory Affairs, Chemical Engineering, FDA, Biopharmaceuticals, R&D, Change Control, Biotechnology

Education
Regulatory Affairs Professionals Society   2014 — 2015
Pharmaceutical and Medical Device Regulatory Affairs

Temple University   2010 — 2013

Georgia Institute of Technology   1995 — 1998
Ph. D, Chemical Engineering

Massachusetts Institute of Technology   1989 — 1990
M.S., Chemical Engineering

Georgia Institute of Technology   1984 — 1989
B.S., Chemical Engineering

University College, London   1988 — 1988
Chemical Engineering Laboratory

Jessica Kokosinski, RAC Jessica Kokosinski, RAC Washington D.C. Metro Area Details
Jessica Kokosinski, RAC's Genpact Pharmalink Experience August 2009 - Present
Job Assistant Vice President
Industry Pharmaceuticals
Experience
Genpact Pharmalink   August 2009 - Present
Biotest Pharmaceuticals Corporation  January 2008 - August 2009
Osiris Therapeutics  June 2006 - December 2007
Quest Pharmaceutical Services  March 2005 - June 2006
Johns Hopkins University  April 2004 - March 2005
BRT Labs, Inc.   1998 - 2002

Skills
FDA, GMP, Validation, GLP, IND, Clinical Trials, Biopharmaceuticals, Quality Assurance, Change Control, Regulatory Requirements, Vaccines, CRO, Clinical Research, CMC, Regulatory Affairs, Regulatory Submissions

Education
University of Maryland Baltimore County   1997 — 2004
Bachelor of Science, Biochemistry and Molecular Biology

David L. Urquhart David L. Urquhart Greater New York City Area Details
David L. Urquhart's Genpact Pharmalink Experience July 2014 - Present
Job Associate Director, Global Regulatory Affairs, Genpact Pharmalink
Industry Pharmaceuticals
Experience
Genpact Pharmalink   July 2014 - Present
DS InPharmatics LLC   January 2012 - July 2014
Forest Laboratories, Inc.   2005 - 2012
Wyeth Pharmaceuticals  2003 - 2005
GlaxoSmithKline  1999 - 2003

Skills
IND, Regulatory Affairs, CMC, FDA, NDA, ANDA, Regulatory Submissions, Regulatory Requirements, Biopharmaceuticals, Change Control, Biologics, Therapeutic Areas, DMF, CMC Regulatory Affairs, CTD

Education
Temple University   1993 — 1999
M.S., Quality Assurance/Regulatory Affairs

Eastern University
B.S., Biology & Chemistry

Claudia Batson, PMP, MBS Claudia Batson, PMP, MBS Newark, New Jersey Details
Claudia Batson, PMP, MBS's Genpact Pharmalink Experience July 2014 - Present
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 Genpact Pharmalink Experience January 2015 - 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 Genpact Pharmalink Experience June 2015 - Present
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

Louise Jones, RAC Louise Jones, RAC San Francisco Bay Area Details
Louise Jones, RAC's Genpact Pharmalink Experience May 2014 - December 2014
Job Associate Regulatory Program Director at Genentech
Industry Biotechnology
Experience
Genentech  January 2015 - Present
Genpact Pharmalink   May 2014 - December 2014
Tokai Pharmaceuticals, Inc.   June 2012 - November 2013
Millennium Pharmaceuticals  June 2012 - March 2013
Tokai Pharmaceuticals  February 2010 - June 2012
Genzyme  2009 - February 2010
TransMolecular   July 2007 - September 2009
Penn State University  August 2006 - June 2007
Inawashiro-machi Board of Education   August 2005 - July 2006

Skills
Regulatory Affairs, Teaching, Biotechnology, FDA, Clinical Development, Pharmaceutical Industry, Drug Development, Clinical Trials, Lifesciences, Oncology, Regulatory Submissions, GCP, Drug Discovery, GMP, Microsoft Office, Pharmacovigilance, Biopharmaceuticals, Clinical Research, Life Sciences

Education
Georgia Institute of Technology   2000 — 2005
BS, Biology

Penn State University   2006 — 2007
Neuroscience

Emily Hawkins Emily Hawkins San Diego, California Details
Emily Hawkins's Genpact Pharmalink Experience November 2012 - August 2015
Job Recruiter at Althea, CMO
Industry Pharmaceuticals
Experience
Althea, CMO  August 2015 - Present
Genpact Pharmalink   November 2012 - August 2015
Hays  May 2012 - October 2012
Adecco Staffing  June 2010 - March 2012
Mothers Against Drunk Driving  2009 - 2009

Skills
Technical Recruiting, Talent Acquisition, Onboarding, Recruiting, Executive Search

Education
University of Denver   2006 — 2010
BA, Sociology, Business

Kelly Brozek Kelly Brozek Greater New York City Area Details
Kelly Brozek's Genpact Pharmalink Experience July 2012 - Present
Job Resourcing and Recruiting Specialist at Pharmalink Consulting
Industry Pharmaceuticals
Experience
Genpact Pharmalink   July 2012 - Present
C-Suite Healthcare   September 2011 - July 2012
Peak Litigation Support   May 2010 - August 2011
Peak Litigation Support   October 2009 - May 2010
Workbridge Associates  July 2008 - August 2009

Education
University of Scranton   2004 — 2008
Bachelors, Human Resources

Andrew Weingarten Andrew Weingarten Greater New York City Area Details
Andrew Weingarten's Genpact Pharmalink Experience February 2015 - Present
Job Associate at Genpact Pharmalink
Industry Hospital & Health Care
Experience
Genpact Pharmalink   February 2015 - Present
New York Hospital Queens  December 2013 - June 2014
North Shore-LIJ Health System  April 2013 - November 2013
Recovery Specialist, Inc.   October 2012 - April 2013
New York Hospital Queens  April 2012 - November 2012
South Nassau Communities Hospital  September 2011 - April 2012
Hofstra University  August 2011 - April 2012
Jaffe & Asher LLP  January 2009 - February 2011
The New York Times  July 2008 - December 2008
AIG  June 2007 - June 2008

Skills
Hospitals, Healthcare Management, Microsoft Word, Business Development, Health Policy, PowerPoint, Microsoft Excel, Regulatory Affairs, Competitive Analysis, Internal Audit, Outlook, OIG, Compliance, Negotiation, Regulatory Development, Compliance Program..., Pharmacueticals, Policy & Procedure..., kpi, Performance Appraisal, Health Consulting, Pharmaceutical Law, Policy & Procedure..., Grant Monitoring, Grant Research, Management, Healthcare Consulting, Analysis, Advertising, Grants, HIPAA, Healthcare

Education
Hofstra University   2010 — 2012
Master of Health Administration (M.H.A.)

State University of New York at Buffalo   2001 — 2006
Bachelor of Arts (B.A.), Business/Corporate/General Communications

Gloria Kulcheski Gloria Kulcheski Clearwater, Florida Details
Gloria Kulcheski's Genpact Pharmalink Experience October 2014 - 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

Heriberto Rodriguez Heriberto Rodriguez Puerto Rico area Details
Heriberto Rodriguez's Genpact Pharmalink Experience March 2014 - Present
Job Lead Consultant Regulatory Affairs at Genpact Pharmalink
Industry Pharmaceuticals
Experience
Genpact Pharmalink   March 2014 - Present
Baxter Healthcare  September 2013 - March 2014
AstraZeneca  2004 - September 2012
AstraZeneca  2001 - 2004
AstraZeneca  1997 - 2001

Skills
Regulatory Affairs, FDA, Sop, CAPA, Trackwise, GMP, Change Control, Quality Assurance, GxP, 21 CFR Part 11, Pharmaceutical Industry, Regulatory Submissions, Regulatory Requirements, Regulatory Filings, CMC, Technical Writing, Quality Auditing, Change Management, Quality Systems, SAP, Root Cause Analysis, Quality Management, Lean Manufacturing, NDA, ISO 13485, Annual Reports, Quality by Design, Supply Chain, Statistics, PSUR, DMF, Chemistry, Document Management, Six Sigma, ICH, SMF, APRs, Compliance, Documentation, Trend Analysis, 21 CFR Part 820, JDE Enterprise One, HMS, Complaints, Non-Conforming, BRS, WMS, Gap Analysis, Compliance Remediation, Remediation

Education
University of Puerto Rico-Cayey
BS, Chemistry, Cum Laude

Padmanabham Navuluri Padmanabham Navuluri Short Hills, New Jersey Details
Padmanabham Navuluri's Genpact Pharmalink Experience May 2015 - Present
Job Vice President, Head of Commercial Solutions at Genpact Pharmalink
Industry Pharmaceuticals
Experience
Genpact Pharmalink   May 2015 - Present
GENPACT LLC  August 2011 - Present
GENPACT LLC  April 2010 - August 2011
Genpact  September 2006 - March 2010
GENPACT LLC  September 2006 - September 2008
GENPACT LLC  January 2005 - August 2006
GE  September 2001 - August 2003
IIM Calcutta   1999 - 2001
Asea Brown Boveri  August 1994 - May 1999

Skills
Pricing, Pre-sales, Globalization, Service Delivery, Offshoring, Solution Architecture, Business Process, Process Management, Strategic Planning, Operations Management, Account Management, Structured Finance, Financial Accounting, Program Management, Leadership Development, Leadership, Process Excellence, Transition Management, Business Process..., Business Process..., Business Transformation, Shared Services, Management, Vendor Management, Global Delivery, Team Management, Business Analysis, Outsourcing, Six Sigma, Finance

Education
Indian Institute of Management, Calcutta   1999 — 2001
MBA, Finance Strategy

Carnegie Mellon University - Tepper School of Business   2011 — 2011
Leadership in Management, Executive Education

College of Engineering, Osmania University   1990 — 1994
BE, Electrical Engineering

Samantha Chalkley Samantha Chalkley Greater New York City Area Details
Samantha Chalkley's Genpact Pharmalink Experience January 2013 - Present
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 Genpact Pharmalink Experience December 2011 - November 2014
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

Ruchira Kannambille Ruchira Kannambille Greater New York City Area Details
Ruchira Kannambille's Genpact Pharmalink Experience March 2014 - Present
Job Senior Regulatory Affairs Consultant
Industry Pharmaceuticals
Experience
Genpact Pharmalink   March 2014 - Present
Planet Pharma  December 2013 - March 2014
Teva Pharmaceuticals  August 2013 - November 2013
Oxford Global Resources  August 2012 - June 2013
AMRI  November 2011 - June 2012
SUN PHARMA  October 2007 - October 2011
AccuMed Inc.  June 2006 - October 2007

Skills
FDA, Stability Programs, Technical Writing, Regulatory Documentation, ICH guidelines, GMP, 21 CFR Part 11, CAPA, Change Control, Quality Control, Quality System, Regulatory Submissions, Software Documentation

Education
Rutgers University-New Brunswick   2002 — 2006
Bachelor's

Ethel Holtzclaw Ethel Holtzclaw Greater Boston Area Details
Ethel Holtzclaw's Genpact Pharmalink Experience December 2011 - May 2015
Job Sr Specialist, Product License Support at Shire
Industry Pharmaceuticals
Experience
Shire  May 2015 - Present
Genpact Pharmalink   December 2011 - May 2015
G&W Laboratories  May 2011 - December 2011
Yoh, A Day & Zimmermann Company   August 2010 - May 2011
Artech Information Systems  March 2010 - August 2010
Schering-Plough Research Institute  August 2008 - March 2010

Skills
Regulatory Affairs, Clinical Trials, Regulatory Submissions, GLP, GCP, eCTD, Drug Safety, Pharmacovigilance, GMP, CMC, Change Control, Document Management, GxP

Education
Rutgers, The State University of New Jersey-Newark   2010 — 2015
Master’s Degree, Clinical Trial Sciences, Concentration in Regulatory Affairs

New Jersey City University   2004 — 2008
Bachelor’s Degree, Biology/Biological Sciences, General

Swarnali Basak Swarnali Basak Gaithersburg, Maryland Details
Swarnali Basak's Genpact Pharmalink Experience September 2015 - Present
Job Quality Control Analyst II at MESO SCALE DIAGNOSTICS
Industry Biotechnology
Experience
Genpact Pharmalink   September 2015 - Present
MESO SCALE DIAGNOSTICS  August 2014 - Present
MESO SCALE DIAGNOSTICS  February 2014 - August 2014
Stephen F. Austin State University  August 2012 - August 2013
Stephen F. Austin State University  August 2011 - August 2012
University of Sussex  December 2007 - August 2008

Skills
real-time PCR, Enzyme Assays, Molecular Cloning, DNA extraction, PCR, Western Blotting, Cell-Culture, Protein Purification, Protein Expression, Chromatography, Bradford Assay, SDS-PAGE, Bioinformatics, Molecular Biology, RNA isolation, Pathogenic Bacteria, Primer Design, Cell Culture, Transfection, Agarose Gel..., cDNA, Proteomics, Purification, Column Chromatography, DNA sequencing, Biotechnology, Protein Chemistry, Genomics, HPLC, Laboratory, BLAST, ELISA, GLP, Sequence Analysis, Genetic Engineering, Spectrophotometry, Assay Development, qPCR, Tissue Culture, RNA Isolation, DNA Extraction, DNA Sequencing

Education
Stephen F. Austin State University   2011 — 2013
Master's degree, Biotechnology

University of Sussex   2008 — 2010
Master's degree, Genetic Manipulation and Molecular Cell Biology

Brian Burke-Green, M.Sc. Brian Burke-Green, M.Sc. Greater Philadelphia Area Details
Brian Burke-Green, M.Sc.'s Genpact Pharmalink Experience December 2013 - April 2015
Job Hub Submissions Manager, Sr Associate at Pfizer
Industry Pharmaceuticals
Experience
Pfizer  April 2015 - Present
Genpact Pharmalink   December 2013 - April 2015
Office of City Commissioner   May 2013 - December 2013
CVS Pharmacy  2006 - 2006

Skills
Regulatory Submissions, ANDA, CTD, cGMP practices, cGMP manufacturing, Generic Drug Regulation, Regulations, Regulatory Affairs, Quality Assurance, GMP, Medical Devices, GLP, Validation, FDA, Pharmaceutical Industry, Clinical Development

Education
St. John's University   2010 — 2013
M. Sc., Pharmacy Administration - RA/QA, 3.84

Temple University   2007 — 2008
BS, Biology

Howard University   2003 — 2006
Biology/ Pre Pharmacy

Glenmuir High School   1996 — 2003

Ghali Asad Ghali Asad Greater New York City Area Details
Ghali Asad's Genpact Pharmalink Experience October 2013 - Present
Job Global Recruiting Specialist | Staffing & Talent Retention Consultant
Industry Staffing and Recruiting
Experience
Genpact Pharmalink   October 2013 - Present
ProSource HR   September 2008 - Present
NYU Langone Medical Center  October 2011 - October 2013
Eccentricity Retail Group   June 2000 - February 2011
MRINetwork // Govig & Associates - Govig Senior Care   August 2005 - September 2008
Eccentricity Retail Group   June 2000 - July 2005

Skills
Recruitment/Retention, Strategic Sourcing, Contract Recruitment, Technical Recruiting, Physician Recruitment, Sales Recruitment, Sourcing, Job Search Strategies, Job Evaluation, Job Design, Program Management, Account Management, Sales Management, Sales Process, Training & Development, Business Strategy, Business Planning, Business Management, Management Consulting, New Business Development, Business Process, Small Business, Recruiting, Employee Training, Management, Hiring, Resume Writing, Project Management, Interviews, Healthcare, Staffing Services, Staff Development, Talent Acquisition, Performance Management, Onboarding, Executive Search, Training, Physicians, Business Development, Personnel Management, Cold Calling, Leadership, Applicant Tracking..., Temporary Placement, College Recruiting, Benefits Negotiation, Talent Management, Screening Resumes, Job Fairs, Employee Relations

Education
University at Albany, SUNY   1998 — 2000
BA, Political Science

City University of New York-College of Staten Island   1994 — 1998
International Relations

Jennifer St.Onge Jennifer St.Onge New Providence, New Jersey Details
Jennifer St.Onge's Genpact Pharmalink Experience July 2015 - Present
Job Lead Associate at Genpact Pharmalink
Industry Pharmaceuticals
Experience
Genpact Pharmalink   July 2015 - Present
Pfizer  January 2015 - June 2015
IKARIA, Inc.   2013 - 2014
Pfizer  June 2012 - August 2012

Skills
Microsoft Office, SPSS, Stata, Data Analysis, Editing, Social Media, PowerPoint, Microsoft Word, Public Speaking, Microsoft Excel, Event Planning, Customer Service, Research, Teamwork

Education
Lafayette College   2009 — 2013
Bachelor of Arts (B.A.), Economics

Pooja Gandhi Pooja Gandhi Greater New York City Area Details
Pooja Gandhi's Genpact Pharmalink Experience March 2015 - Present
Job Senior Manager Regulatory Affairs at Genpact Pharmalink
Industry Pharmaceuticals
Experience
Genpact Pharmalink   March 2015 - Present
eVenus Pharmaceutical Laboratories, Inc.   July 2014 - March 2015
Regeneron Pharmaceuticals  January 2012 - July 2014
Pfizer  October 2009 - December 2011
Wyeth  2005 - 2009
Wyeth Research  1998 - 2005
Wyeth Research  1996 - 1998

Skills
Formulation, Sop, Pharmaceutical Industry, Regulatory Affairs, Clinical Development, FDA, Drug Development, R&D, HPLC, GLP, GMP, Technology Transfer, Regulatory Submissions, Drug Discovery, Regulatory Requirements, Biotechnology, Biopharmaceuticals, Validation, LIMS, Research, Chromatography, Pharmaceutics, CMC Regulatory Affairs, Clinical Trials, Change Control

Education
Iona College   2003 — 2006
MBA, Marketing, International Business

Long Island University   1997 — 2001
MS, Pharmaceutics, Industrial Pharmacy

State University of New York College at Plattsburgh   1995 — 1996
BS, Biochemistry

University of Rochester   1992 — 1995

Fred Korley Fred Korley Greater New York City Area Details
Fred Korley's Genpact Pharmalink Experience January 2014 - November 2014
Job Project Manager at SANOFI
Industry Pharmaceuticals
Experience
SANOFI  December 2014 - Present
Genpact Pharmalink   January 2014 - November 2014
Bayer HealthCare  January 2010 - August 2013
Pfizer Inc.  February 2007 - January 2010
Pfizer Inc.  August 2006 - December 2006
Boston Scientific  May 2006 - August 2006
Pfizer  October 1999 - May 2006
Johnson & Johnson  February 1999 - October 1999
Warner Lambert  January 1997 - February 1999
Bell Labs Lucent Technologies  February 1996 - December 1996

Skills
FDA, Validation, Regulatory Affairs, GMP, SOP, Pharmaceutical Industry, Biotechnology, Regulatory Requirements, Quality Assurance, HPLC, Drug Development, UV/Vis, Regulatory Submissions, Clinical Trials, V, Regulatory Intelligence, Global Regulatory...

Education
Temple University- School of Pharmacy   2006 — 2009
MS, Quality Assurance & Regulatory Affairs

Kean University   2003 — 2006
BA, Chemistry

Marshall LaRusso Marshall LaRusso Greater New York City Area Details
Marshall LaRusso's Genpact Pharmalink Experience October 2014 - Present
Job Manager, Recruitment at Genpact Pharmalink
Industry Pharmaceuticals
Experience
Genpact Pharmalink   October 2014 - Present
Verizon Wireless  June 2014 - October 2014
Concepts In Staffing  November 2013 - June 2014
The Mergis Group  August 2013 - November 2013
AG Harding & Company   November 2008 - August 2013
Salem Executive Search   March 2006 - November 2008
Lehman Brothers  May 1997 - March 2005

Skills
Executive Search, Career Counseling, Consulting, Employee Relations, New Business Development, Business Development, Strategic Planning, Team Building, Leadership Development, Strategic Sourcing, Contract Negotiation, Sales Management, Business Strategy, Marketing, Strategy, Team Leadership, B2B, Technical Recruiting, Talent Acquisition, Contract Recruitment, Temporary Placement, Sourcing, Recruiting, Human Resources, Temporary Staffing, Resume Writing

Education
Colorado State University   1990 — 1994
Bachelor of Arts (B.A.), Economics

Randolph High School   1984 — 1988

Malini Joshi Malini Joshi Greater New York City Area Details
Malini Joshi's Genpact Pharmalink Experience March 2012 - Present
Job Senior CMC Specialist at Genpact Pharmalink
Industry Pharmaceuticals
Experience
Genpact Pharmalink   March 2012 - Present
Eisai Pharmaceuticals  August 2008 - March 2012
Schering-Plough  September 2004 - August 2008

Skills
Pharmaceutical Industry, Regulatory Affairs, Clinical Development, Clinical Trials, GCP, GMP, Regulatory Submissions

Education
Gujarat University   1986 — 1989

Jennifer Labaczewski Jennifer Labaczewski Greater New York City Area Details
Jennifer Labaczewski's Genpact Pharmalink Experience October 2011 - Present
Job Director of Talent Acquisition for Pharmalink Consulting
Industry Pharmaceuticals
Experience
Genpact Pharmalink   October 2011 - Present
Sabert Corporation  January 2011 - October 2011
Sanofi  September 2004 - December 2010
Wall Street Services  February 2002 - September 2004

Skills
Recruiting, Talent Management, Talent Acquisition, Onboarding, Sourcing, Human Resources, Management, Applicant Tracking..., Leadership, Interviews, Internet Recruiting, Training, Screening Resumes, Hiring, Job Descriptions, Technical Recruiting, Career Development, Employee Relations, Sales, Temporary Placement, HR Consulting, Employee Training, Taleo, Personnel Management, Behavioral Interviewing, Succession Planning, Negotiation, Resume Writing, Benefits Negotiation, Recruitment Advertising, Contract Recruitment, Employee Engagement, Workforce Planning, Deferred Compensation, HRIS, Executive Search, Staffing Services, New Hire Orientations, Performance Management, College Recruiting, Screening, Benefits Administration, Organizational..., Employer Branding, HR Policies, Organizational Design, Employee Benefits, Temporary Staffing, Labor Relations, Strategic Sourcing

Education
Ithaca College   1993 — 1997
B.A, Psychology

Patricia Thorman Patricia Thorman Greater New York City Area Details
Patricia Thorman's Genpact Pharmalink Experience August 2014 - Present
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

Christine Wilson Christine Wilson Greater New York City Area Details
Christine Wilson's Genpact Pharmalink Experience March 2014 - January 2015
Job North America Clinical Study Unit at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences  May 2015 - Present
Genpact Pharmalink   March 2014 - January 2015
Novartis Consumer Health  April 2012 - March 2014
Pfizer  November 2003 - April 2012
Warner Lambert  1998 - 2000

Skills
Sop, Regulatory Affairs, Pharmaceutical Industry, Regulatory Submissions, FDA, GMP, 21 CFR Part 11

Education
Radford University   1993 — 1997
Bachelor of Arts, Liberal Arts Studies

Morristown High

Erica Dingman (Aagre) Erica Dingman (Aagre) Greater New York City Area Details
Erica Dingman (Aagre)'s Genpact Pharmalink Experience January 2009 - Present
Job Senior Regulatory Manager
Industry Pharmaceuticals
Experience
Genpact Pharmalink   January 2009 - Present
Pfizer  October 2009 - December 2010
Wyeth  March 2008 - October 2009
Pfizer Pharmaceuticals  February 2007 - March 2008
Saint Clare's Health System  2001 - 2007

Skills
Regulatory Affairs, Regulatory Submissions

Education
Lock Haven University of Pennsylvania
Bachelor of Science, Health Science

Nagesh Virupaksha Nagesh Virupaksha Greater New York City Area Details
Nagesh Virupaksha's Genpact Pharmalink Experience March 2010 - September 2011
Job Regulatory Affairs Sr Manager, GE Healthcare
Industry Pharmaceuticals
Experience
GE Healthcare  July 2012 - March 2015
Savient Pharmaceuticals, Inc.   November 2011 - April 2012
Genpact Pharmalink   March 2010 - September 2011
Merck  October 2009 - March 2010
Johnson & Johnson  November 1997 - May 2009

Skills
Pharmaceutical Industry, SOP, FDA, GMP, Validation, CAPA, 21 CFR Part 11, Biotechnology, Change Control, GLP, Regulatory Affairs, Regulatory Submissions, Lifesciences, Pharmaceutics, Medical Devices, Sop, Research, Computer System..., HPLC, LIMS, Drug Discovery, Technology Transfer, Quality System, Analytical Chemistry, Regulatory Requirements, V&V, GCP, Chemistry, Clinical Development, Quality Assurance, Clinical Research, Clinical Trials, R&D, Chromatography, Oncology

Education
Sri Sathya Sai Institute of Higher Learning
M.Sc Chemistry, Spectroscopy/Analytical Organic Chemistry

Temple University
M.S., QA/Reg Affairs

Stephen Doherty Stephen Doherty Greater New York City Area Details
Stephen Doherty's Genpact Pharmalink Experience 2012 - Present
Job Vice President Regulatory Affairs at Genpact Pharmalink
Industry Pharmaceuticals
Experience
Genpact Pharmalink   2012 - Present
Novartis  May 2011 - January 2012
Merck  October 2009 - May 2011
Schering-Plough Research Institute  December 2005 - October 2009
Merck Sharp & Dohme  1987 - 2005
Ciba-Geigy Pharmaceuticals  1981 - 1987

Skills
Drug Development, Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, GMP, Pharmaceutics, FDA, Sop, Technology Transfer, Clinical Development, Clinical Trials, Biopharmaceuticals, CMC, Validation, SOP

Education
Rutgers University-New Brunswick   1981 — 1987
MS, Analytical Chemistry

Rutgers University-New Brunswick   1977 — 1981
BA, Chemistry

Avni Balwani Avni Balwani Greater New York City Area Details
Avni Balwani's Genpact Pharmalink Experience December 2013 - August 2015
Job Regulatory Affairs Professional
Industry Pharmaceuticals
Experience
Impax Laboratories  August 2015 - Present
Genpact Pharmalink   December 2013 - August 2015
Teva Pharmaceuticals  January 2013 - November 2013
NJ Center for Biomaterials  July 2012 - October 2012
Progenitor Cell Therapy  September 2009 - August 2011

Skills
Biotechnology, Drug Development, Regulatory Affairs, Project Management, Business Development, Validation, GMP, GLP, GTP, SOP, Cell Therapy, Genomics, Marketing, Sop, Pharmaceutical Industry, Lifesciences, FDA, Regulatory Submissions, Life Sciences, Change Control, Regulatory Requirements

Education
Rutgers University   2011 — 2012
Master of Business and Science, Specialization: Biotechnology & Genomics

Rutgers University-New Brunswick   2005 — 2009
Bachelors, Biological Sciences, Pscyhology

Parsippany Hills High School

Preeti Yadava, PhD., PMP Preeti Yadava, PhD., PMP Greater New York City Area Details
Preeti Yadava, PhD., PMP's Genpact Pharmalink Experience 2013 - Present
Job at Genpact Pharmalink
Industry Pharmaceuticals
Experience
Genpact Pharmalink   2013 - Present
Ramapo College of New Jersey  January 2015 - Present
Hoffman-La Roche  November 2009 - June 2013
American Association of Pharmaceutical Scientists (AAPS)   2002 - 2010
Hoffmann-La Roche  March 2008 - November 2009
University of the Sciences in Philadelphia  2007 - 2007

Skills
Regulatory Affairs, Project Management, Drug Delivery, Formulation, Drug Discovery, Pharmacokinetics, Drug Development, GLP, In Vitro, Pharmaceutical Research, Biopharmaceuticals, HPLC, Tissue Culture, Biotechnology, Liposomes, Solubility, Assay Development, Quality by Design, GMP, Sop

Education
PMI   2013 — 2013
PMP

University of Florida   2002 — 2007
Ph.D., Pharmaceutics

Panjab University   1998 — 2002
B. Pharm, Pharmacy

Donald Esherick Donald Esherick Greater Philadelphia Area Details
Donald Esherick's Genpact Pharmalink Experience December 2011 - Present
Job Vice President, Development CMC at Genpact Pharmalink
Industry Pharmaceuticals
Experience
Genpact Pharmalink   December 2011 - Present
Pfizer  October 2009 - November 2011
Wyeth Pharmaceuticals  September 2000 - September 2009
Rhone-Poulenc Rorer  January 1994 - May 2000
Fisons Pharmaceutical   1990 - 1994
Rorer Pharmaceutical   1986 - 1990

Skills
FDA, Regulatory Affairs, CMC, Regulatory Submissions, Pharmaceutical Industry, Regulations, Validation, Quality by Design, GMP, IND, eCTD, Regulatory Requirements

Education
Westminster Theological Seminary   1982 — 1987
MA, Religion (Biblical Studies)

Penn State University   1974 — 1978
BS, Biology

Sol Colon Sol Colon United States Details
Sol Colon's Genpact Pharmalink Experience November 2014 - 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

Jason Funk Jason Funk Greater Philadelphia Area Details
Jason Funk's Genpact Pharmalink Experience October 2014 - Present
Job Pharmaceutical Regulatory Affairs Associate
Industry Pharmaceuticals
Experience
Genpact Pharmalink   October 2014 - Present
Medical University of South Carolina  August 2012 - July 2014
Medical University of South Carolina  August 2007 - August 2012
National Institute of Environmental Health Sciences (NIEHS)   August 2005 - August 2007

Education
Medical University of South Carolina   2007 — 2012
Doctor of Philosophy (Ph.D.)

The Ohio State University   2001 — 2005
Bachelor of Science (B.S.)

Candace Renfrow Candace Renfrow Greater Philadelphia Area Details
Candace Renfrow's Genpact Pharmalink Experience 2014 - Present
Job Assistant Vice President at Genpact Pharmalink
Industry Pharmaceuticals
Experience
Genpact Pharmalink   2014 - Present
QVC  2012 - 2014
Endo Pharmaceuticals  2009 - 2012
Pfizer  2005 - 2009
Pfizer  2003 - 2005
TIAA-CREF  2000 - 2003
TIAA-CREF  1998 - 2000
TIAA-CREF  1995 - 1998
Barneys New York  1994 - 1995

Skills
Talent Management, Change Management, Organizational..., Workforce Planning, Mergers & Acquisitions, Succession Planning, Leadership Development, Oncology, Pharmaceutical Industry, Employee Engagement, Leadership, Employee Benefits, Deferred Compensation, Talent Acquisition, Onboarding, Organizational Design, Organizational..., Employee Relations, Performance Management, HRIS, Applicant Tracking..., Personnel Management, HR Policies, Executive Coaching, Management

Education
University of Pennsylvania
Master of Science (M.S.), Organizational Dynamics

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