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ImClone Systems Incorporated Open Job Positions
AD Medical Affairs Training Compliance
Branchburg ,
New Jersey
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DIVISION: ImClone Systems Incorporated -
SKILLS & RESPONSINBILITIES:
1.Assembling, Preparing and Implementing Training materials and programs for ImClone pipeline molecules for medical affairs
2.Submit all prepared materials to Medical Affairs management and to MARC for approval prior to use with other personnel
3.Monitoring compliance requirements for the Medical Affairs department and tracking department completion of training require ..
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Associate Director Drug Safety
Bridgewater ,
New Jersey
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DIVISION: ImClone Systems Incorporated -
GENERAL SUMMARY:
Provide assistance in the management of all adverse event reports received by ImClone including, but not limited to clinical and regulatory assessment of individual reports, preparation of reports, maintenance of electronic database, report follow-up and preparation of standard as well as ad hoc adverse event reports.
ESSENTIAL DUTIES AND
RESPONSIBILITIES:
1. Manage the process ..
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Associate Director, Drug Safety
Bridgewater ,
New Jersey
Job First Active on:
DIVISION: ImClone Systems Incorporated -
GENERAL SUMMARY:
Provide assistance in the management of all adverse event reports received by ImClone including, but not limited to clinical and regulatory assessment of individual reports, preparation of reports, maintenance of electronic database, report follow-up and preparation of standard as well as ad hoc adverse event reports.
ESSENTIAL DUTIES AND
RESPONSIBILITIES:
1.Assist the Director a ..
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Associate Director, Regulatory CMC
Bridgewater ,
New Jersey
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DIVISION: ImClone Systems Incorporated -
GENERAL SUMMARY:
Advanced knowledge of regulations, guidance documents and corporate/industry standards and an ability to evaluate same for impact on strategic plans and tactical operations. Good scientific/technical knowledge, provides committed, value-added effort in support of development projects. Must be detail-oriented with good verbal and written communications skills; able to supervise th ..
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Associate Product Manager
Bridgewater ,
New Jersey
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DIVISION: ImClone Systems Incorporated -
GENERAL SUMMARY:
? Manage all commercial aspects for products in Imclone’s portfolio of targeted antibodies.
? Provide intellectual leadership and ongoing project management support for forecasting and long range planning and portfolio process.
? Coordinate with market research/competitive intelligence function to ensure a comprehensive plan for the successful development and launch for pipeline p ..
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Clinical Pharmacology, Project Manager
Branchburg ,
New Jersey
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DIVISION: ImClone Systems Incorporated -
GENERAL SUMMARY
This position is responsible for coordinating, tracking and optimizing the interactions of the Clinical Pharmacology group with other functional areas witin ImClone Systems ( i.e.- non-clinical, clinical, regulatory, medical writing and manufacturing.) The candidate must be able to work within a team, as well as independently, to understand, prioritize and efficiently assist in co ..
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Data Manager
Bridgewater ,
New Jersey
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DIVISION: ImClone Systems Incorporated -
General Summary:
Contribute to data management activities related to drug product development for assigned compounds or indications. Collaborate with internal biostatistics, Clinical Operations, and CRO data management and biostatistics.
Essential Duties & Responsibilities:
1. Lead efforts for eCRF design with Biostatistics and Clinical Operations and coordinate a final CRF, edit checks, data rev ..
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Director, Drug Safety
Bridgewater ,
New Jersey
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DIVISION: ImClone Systems Incorporated -
GENERAL SUMMARY:
Assist in the overall management of Drug Safety operations, including preparation and review of safety reports, case assessment, assessment for safety signals, preparation of standard as well as ad hoc adverse event reports, staff management and mentoring, database maintenance and upgrades, and contribution to regulatory and clinical regulatory documents.
ESSENTIAL DUTIES AND
RES ..
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Director, Manufacturing Technology CMC Regulatory Support
Branchburg ,
New Jersey
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DIVISION: ImClone Systems Incorporated -
GENERAL SUMMARY:
Individual will lead a team that will provide support to the Regulatory Affairs (CMC) Organization. This team’s primary responsibility will be to provide the technical content for the Chemistry, Manufacturing and Controls (CMC) sections of all investigational drug applications (INDs, CTAs) and any required amendments, initial marketing applications along with any required supplem ..
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Documentation Coordinator
Branchburg ,
New Jersey
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DIVISION: ImClone Systems Incorporated -
GENERAL SUMMARY
Responsible for the review, routing, distribution, labeling and filing of GMP documentation. Update and maintain document tracking databases and archival systems. Administer Periodic Review and Binder Audit programs for GMP documents. This position requires a thorough knowledge of computer applications in the Microsoft Office Suite; including scanning of documentation. Some physica ..
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