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Eisai Inc.
Associate Director/Director, Clinical Operations, SOCS CFU
Location: Ridgefield Park,
New Jersey
07660
Posted on:
9/4/2009 9:53:46 AM
Postion type:
Full time
Job Code:
1650200HHL
Required Education:
High school or equivalent
Salary:
Competitive
DESCRIPTION
Eisai Inc., Eisai Medical Research and Eisai Corporation of North America are U.S. subsidiaries of Tokyo-based Eisai Co., Ltd., a research-based human health care company, that discovers, develops, and markets products throughout the world.
At Eisai (a-zi), caring for people is our work. Satisfying unmet medical needs and increasing benefits to patients, their families, and caregivers is Eisai's human health care (hhc) mission. This includes the development of innovative medicines-notably the discovery of the world's most widely used treatment for Alzheimer's disease.
As a company growing at a fast pace, Eisai offers its employees opportunities to thrive. We recognize that our people are our greatest asset, and are committed to providing a work environment that will attract and retain talent. Eisai enables and empowers all employees to make significant contributions. That is our quest. That is our promise. That is what makes us Eisai.
With more than 2,500 employees in the U.S. and sites located in Woodcliff Lake, NJ, Ridgefield Park, NJ, Baltimore, MD, and Research Triangle Park, NC, we work and live by our values: Integrity, Respect, Professionalism, Quality and Teamwork.
1.Key member of the transformation work-streams providing Clinical Operations and Data Management expertise: (e.g. IVRS, ISEP, eDC)
Process Standardization initiatives (SOPs/SWPs, Reports, Best Practices)
Review of forms, guidelines, and tools associated with standard best practices
SOP learning plan update and maintenance
Organization and communication of process progress (surveys, materials, tools)
2.Serve as eDC regional expert working across PCUs to train and manage teams to the inform tool
3.Implement and drive training programs (Clin Ops, DM) for all CFU and PCU Clinical Operations and Data Management teams, apply expertise in tandem with working knowledge of other technical disciplines (e.g., therapeutic areas, regulatory filing) and support the execution of Clinical Operations & Data Management strategies, and implementation of new processes and systems
4.Manage the central document and QC teams, provide over-site to Clinical Operations databases: ISAD Safety and Investigator Background checks
5.Influence work processes spanning multiple department and geographic boundaries within Eisai, develop networks with external stakeholders, lead problem solving with an enterprise-wide perspective; facilitating teams to identify Clinical Operations & Data Management issues and propose solutions, and role model teamwork/collaboration in decision making process with respect to Clinical Operations & Data Management areas
6.Align Clinical Operations & Data Management objectives across multiple project teams, motivate exceptional performance, and act as an informal mentor and coach
Minimum of a Bachelor of Science degree in a relevant scientific discipline.
7-10 years relevant experience in the pharmaceutical industry, including line management experience
Advanced degree (MS, MBA or PhD) highly preferred
At Eisai, we recognize that our employees are our greatest asset. That is why we reward them with highly competitive salaries, annual incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, Tuition and Health Club Reimbursement, and the list doesn't stop there. Since we intend to recruit the best of the best candidates, this is how we maximize our competitive advantage in the marketplace.
EOE
REQUIREMENTS:
See Job Description
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