Friday, July 01, 2011

FDA Warns Against Abbott's Depakote - July 1, 2011

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•  FDA Warns Against Abbott Laboratories (ABT)'s Depakote for Pregnant Women More...

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•  FDA Approves Archimedes Pharma's Lazanda(R) - First Fentanyl Nasal Spray - for the Management of Breakthrough Pain in Cancer Patients More...
•  Merck & Co., Inc. (MRK) Receives Approval to Market GARDASIL(R), ZOLINZA(R) and CUBICIN(R) in Japan More...

More Drug Approval News
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•  VIVUS, Inc. (VVUS) Files for FDA Approval of Impotence Drug More...
•  MediStem, Inc. (Formerly known as Medistem Laboratories, Inc.) Licensee RenovoCyte LLC Receives FDA INAD for Universal Donor Endometrial Regenerative Cells (ERC) More...
•  AVANIR Pharmaceuticals (AVNR) Announces Paragraph IV ANDA Filing for NUEDEXTA More...

More BLA/NDA/ANDA News
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•  Red Wine: Exercise in a Bottle?, Study in FASEB Journal More...
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•  Potential of Simple Injection on Patients with Head Injury, London School of Hygiene and Tropical Medicine Study More...
•  Clinical Study of Epilepsy Drug May Have Been Purely Promotional, Yale University Reveals More...

More General Clinical Research News
Events

Join us for the 40th Annual Meeting of the American College of Clinical Pharmacology, Sept. 11-13, 2011 at the Crowne Plaza Chicago O'Hare Hotel, Chicago (Rosemont), IL, covering a wide range of current, relevant topics as noted below. CME and CPE credits available for registered attendees.

• Transdermal Delivery Systems
• Opioids and Psychotropic Drugs
• First-in-Human Clinical Trials
• Model-based Drug Development
• Biotherapeutic Dose Selection Strategies
• Drug Safety vs. Disease Treatment
• Quantitative Clinical Pharmacology in Inflammation & Immunology
• Imaging Techniques in Drug Development
• Bridging Clinical Trials
• Innovations in Pharmacoepideomiology
• Hormone Therapy in Menopausal Women

Keynote speakers include: Francis S. Collins, MD, PhD, Director of the National Institutes of Health (NIH) on Sunday, Sept 11th and Anne Schuchat, MD, Director of the CDC's National Center for Immunization and Respiratory Diseases (NICRD) on Monday, Sept 12th.

Additional information about the ACCP 40th Annual Meeting and the Preliminary Program are available online or contact TStevens@ACCP1.org.
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Bio NC (Durham, North Carolina)

PAREXEL International
Clinical Trials Project Leader Phase II / III
Lead and manage domestic or international projects. May be part of a global project management team. Requires some interaction/supervision by Line Manager or Senior Project Leader or Director. Etc.

Biotech Beach (Irvine, California)

Edwards Life Sciences
Clinical Research Associate
Oversight of all study documentation review (for completeness), filing and tracking activities to ensure compliance. This includes the Master files, Site file and Business files for THV each study. Etc.

Biotech Bay (Newark, California)

Synarc, Inc.
Clinical Data Manager
Provides accurate, timely, and consistent clinical data to client organizations and internal staff to support business objectives. The Clinical Data Manager defines and directs the data management workflow. Etc.

Genetown (Rockville, Maryland)

Novartis Institutes for BioMedical Research, Inc.
BS/MS Level In Vivo Biologist: Oncology Research
The successful candidate will join a dynamic, multi-disciplinary team of scientists in the In Vivo Pharmacology Oncology Department, playing a key role in the development of in vivo models of cancer and the use of those models for evaluating new drug candidates.

Pharm Country (Ridgefield, Connecticut)

Kforce Clinical Research
Clinical Research Associate
To collaborate in the identification and drive the selection of investigator sites with input from other cross-functional groups. Also monitors investigator sites in compliance with company SOPs, ICH/GCP and local laws so that site performance targets are achieved. Etc.

• Get Noticed! Add your resume to the BioSpace Career Center!
• See more than 5,000 job postings in the BioSpace Career Center!


Biotech Beach Career Fair

Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the Southern California region.

Candidates with a 4-year degree in the life sciences and a minimum of 2-years of industry related experience are invited to attend. (Equivalent work experience may be considered in lieu of a four-year college degree. PhD and Postdoc candidates welcome.)

Exhibiting companies are recruiting for positions in areas such as: QA/QC, clinical research, engineering, manufacturing, biostatistics, clinical data management, chemistry, regulatory affairs, and research.

Job seekers may register here.

Biotech Beach Career Fair, San Diego, CA September 22, 2011
BioMidwest Career Fair, Chicago, IL October 4, 2011
Pharm Country Career Fair, Bridgewater, NJ October 5, 2011
Biotech Bay Career Fair, Burlingame, CA October 11, 2011
Bio NC Career Fair, Durham, NC October 20, 2011
BioCapital Beach Career Fair, Bethesda, MD November 1, 2011
Genetown Career Fair, Cambridge, MA November 7, 2011

More information about BioSpace's Career Fairs

BioSpace White Paper
Biotech Career Fairs For Job Seekers 101: Control Your Experience
By June Salvati, BioSpace Director of Events and Corporate Services
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