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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 you’d like to join a company where you can make a difference, please consider the Celgene family.
Prerequisites
BS/BA degree in Biomedical Science (Masters preferred) with 7+ years in the pharmaceutical industry or in a CRO, including 3+ years of writing experience
Summary
Responsibilities include:
1. Provide leadership, strategic planning & effective management and guidance to all
functional areas within Global Scientific & Medical Writing. Liaise with Japanese Medical
Writing to effectively manage global regulatory submission documents.
2. Manage the performance of Global Scientific & Medical Writing personnel who are
responsible for the planning, authoring, compilation, review and approval of global regulatory
submission documents (protocols, amendments, briefing books, investigators brochures,
clinical study reports and summary documents).
3. Provide leadership to the global community in developing & managing existing standards,
processes & practices. Ensure continuous improvement of these processes & practices.
Ensure proper and timely training to optimize the introduction and implementation of new
workflow processes and technologies.
4. Manage the Global Scientific & Medical Writing groups (medical writers, quality control and
document processing & coordination) and assure regulatory compliance and adherence to
GCP standards. Must participate actively in all activities necessary.
5. Develop a strong Global Scientific & Medical Writing group across multiple domestic &
international sites. Develop & coach subordinates to assure timelines are met and conflicts
are resolved quickly.
6. Liaise with CROs and independent contractors to define tasks, monitor performance, and
provide direction. Evaluate medical writing consultants with regard to processes, SOPs, and
global templates. Manage support for medical writing activities outsourced to CROs and
independent contractors.
7. Build strong external network with professionals in the pharmaceutical industry.
Skills/Knowledge Required
• Extensive knowledge of health authority regulations, policies, and guidelines pertaining to
global dossiers.
• Extensive knowledge of GCP requirements and the drug development process.
• Demonstrated experience in strategic and multiproject planning, including resource
allocation and budgeting.
• Demonstrated experience in fostering and managing external writing resources (i.e.,
independent contractors, CROs).
• Excellent written and oral communication skills.
• Excellent organizational skills.
• Expert level with electronic templates and complex documents.
• Expert level with document repository management applications (e.g., eSub Livelink).
• Expert level with MS WORD including table functions and working with styles.
Competencies:
Thinks Strategically
Manages Execution
Leverages Networks
Leads Courageously
Influencing Others
Motivates Others
Fosters Teamwork
Effective Speaking
Fosters Open Communication
Displays Organizational Savvy
Focus on Customer Needs
Coaching and Developing Others
Provides Directions
Structuring and Staffing
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 employee’s 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:
18776915
Posted / Updated:
6/13/2010 3:37:28 AM
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