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Description
About Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 60 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology and hematology. If youd like to join a company where you can make a difference, please consider the Celgene family.
Prerequisites
Degree in life sciences or medically related field. A business degree, such as an MBA or Masters in a business-related area, is desirable. Minimum 3-5 years relevant experience in life sciences or medically related field, with some portion of that spent in Clinical and/or other related Biopharmaceutical R&D functions, or demonstration of required skills and knowledge.
Summary
Responsibilities will include, but are not limited to the following:
1. Understand Celgenes evolving portfolio priorities and incorporate them into key audit
planning activities related to the global Clinical organization.
2. Planning of audits in collaboration with the CQA Management team.
3. Gather and synthesize information regarding global Clinical activities which impact on
Clinical Quality assurance resources and timelines.
4. Assist the VP Clinical QA in developing and communicating short and long-term resource
plans.
5. Work with various Clinical line functions to update the anticipated study demand and
assumptions around duration and effort for key study-related activities on an ongoing basis
which affect clinical quality assurance SOPs/WPs and other activities.
6. Support Clinical QA budgeting process as it relates to global internal headcount
requirements and required level of outsourcing (consultants).
7. Assist in the planning and execution of global training.
8. Support VP CQA in enhancing CQA internal processes.
9. Support VP CQA and CQA management team in determining effectiveness of outputs from
reports (metrics, CAPAs, trends etc.).
10. Support VP in tracking objectives to ensure timely and adequate completion.
11. Support CQA management with prioritization of activities.
Key requirements / knowledge:
Degree in life sciences or medically related field. In addition, a business degree, such as an
MBA or Masters in a business-related area, is desirable
Minimum 3-5 years relevant experience in life sciences or medically related field, with some
portion of that spent in Clinical and/or other related Biopharmaceutical R&D functions
First hand experience in strategic planning, resource management, etc. for a Global
organization
Sound understanding of Clinical Development processes and procedures
Ability to develop long-range strategic plans for the Clinical QA organization
Good understanding of what drives resource requirements
Ability to make sound tradeoff decisions (e.g., in-source vs. outsource, cost-benefit analyses,
etc.)
Ability to effectively translate multi-year corporate level priorities into priorities for the Clinical
QA
Experience in successfully coordinating across several complex functions to ensure
comprehensive and consistent planning
Ability to provide adequate support and leverage to the VP CQA on day-to-day operational
tasks
Good understanding of how to develop and track audits, CAPAs, resource and budgets
Competencies / skills:
Strong business judgment and acumen
Relevant IT skills (able to work with visio, Microsoft project)
Strategic, big picture thinking
Analytical and problem solving skills
Creative thinking
Strong written and oral communication
Meeting management / facilitation skills / teamwork
Operational capabilities
People management skills
People development skills
Equal Employment Opportunity
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employees temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the at-will employment relationship between the employee and Celgene.
Details:
Job Id:
19245237
Posted / Updated:
10/9/2010 3:39:37 AM
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