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Medical Operations Leader

PAREXEL International

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Location: Billerica, MA Posted Date: 4/8/2013 Position Type: Full time Job Code: pare-10025515 Required Education: High school or equivalent Areas of Expertise Desired: Operations

Description

Medical Operations Leader Drug Safety

Do you possess cutting edge clinical / medical drug safety expertise, and the ability to successfully manage multiple projects simultaneously? Come to an industry leader where you will have the opportunity to utilize your strengths in strategy and planning, client relationship management, and operational execution. Provide oversight and direction for all Medical Services and Pharmacovigilance projects, including SAE management, medical monitoring, clinical event data monitoring committees, and clinical and post-marketing related projects and activities.

To be successful in this role you will be familiar with clinical trial safety management, safety databases, regulatory reporting of serious adverse events, medical monitoring, and project management. You will lead, manage, mentor, and support your team to achieve the goals of delivering quality projects to clients, while improving overall quality and client satisfaction.

GROWTH:
While most companies were busy downsizing, during 2010 PAREXEL opened two new offices and added over 800 employees!

PROMOTION:
In 2010, more than 1700 PAREXEL employees received career promotions!!

EXPERTISE:
PAREXEL's experts, who have experience across a broad range of therapeutic areas, have supported nearly all of the top 50 best-selling drugs that are on the market today.

AWARDS:
PAREXEL was named Company of the Year 2010 for the Pharmaceutical Industry in The Eighth Annual International Business Awards, the only global, all-encompassing business awards program honoring great performances in business.
PAREXEL announced that the Company had been included on the 'Best 5'Pharmaceutical' industry sublist 2010 as part of The International Association of Outsourcing Professionals® (IAOP®) annual ranking The Global Outsourcing 100.
PAREXEL was recognized as a Best 10 Outsourcing Company for the Pharmaceutical Industry as part of the Global Outsourcing 100® 2010, and also received Scrip Award for Clinical Research Team of the Year.
PAREXEL was recognized as Best Performing CRO 2009 by BioSingapore for its leadership in the Asia/Pacific region, and ranked in the Top 10 among best performing Massachusetts-based public companies in The Boston Globe 100, as well as a Top Employer (ranked by number of worldwide employees)

Keywords: drug safety, pharmacovigilance, serious adverse event SAEs, post marketing, clinical, clinical research, project management, PM, clinical trial, clinical trail, clinical study, CRO, CRF, pharmaceutical, biotechnology, biotech, medical device

Requirements

Skills:
knowledge of drug safety and the drug development process
knowledge of and ability to interpret and apply global safety and other relevant regulations


Education:
Degree in Pharmacy, Nursing, Life Science, or other health care provider related field, or equivalent qualification; Associates/diploma degree in any of the above with appropriate work experience

Minimum Work Experience:
drug safety knowledge and experience
experience of working in drug development and/or healthcare environment
Management experience a must
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