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Mitsubishi Chemical Group
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Jersey City, New Jersey
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overseeing one or more therapeutic areas, and coordinates strategy with RA project management for assigned ... cross-functional project teams and responsible for product development and post marketing commitments
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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guidance to cross-functional project teams and responsible for product development and post marketing ... Director, Regulatory Affairs - Clinical also works directly with cross-functional project teams to execute
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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developmentplan and resources. Represent the project at senior management and governance stage-gate approval ... tactically.
Well-honed project management skills with proven ability to simultaneously manage activities
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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regulatory guidance to cross-functional project teams and responsible for product development and post ... Director, Regulatory Affairs - Clinical also works directly with cross-functional project teams to execute
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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marshal teams to achieve goals.
Well-honed project management skills; proven ability to ... ).
Oversee planning and support operational aspects of clinical trial execution, data management and data
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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plan and resources.
Represents project(s) at senior management and governance stage-gate approval ... development team member, the incumbent will lead the successful delivery of milestones for assigned project(s
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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development plan and resources. Represent the project at senior management and governance stage-gate approval ... execution, data management and data analysis in partnership with Global program and project leaders from
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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performance indicators.
Prepare and present in Quality Management meetings such as Material Review Board, Change Control Board, Quality Escalations and Quality Management Review.
Review CMC sections of NDAs
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Mitsubishi Chemical Group
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Jersey City, New Jersey
...
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Well-honed project management skills. Proven ability to simultaneously manage activities associated ... all facing illness.
The primary role of the Director, Learning Management & Training will be to
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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all facing illness.
The Senior Director, Quality Management System will be responsible for the design, development and maintenance of a phase-appropriate, risk-based Quality Management System
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Mitsubishi Chemical Group
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Jersey City, New Jersey
...
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Minimum of 5 years of administrative/project management experience.
Minimum of 3 years of experience ... regulations, and global regulations for the management of Quality related
Coordinates and tracks the
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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cross functional teams (Biostatistics, Clinical Operations, Data Management, Regulatory, PK/ADME ... , project, corporate and scientific meetings.
Qualifications
Advanced Degree in Life
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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** 2024-1842
# of Openings 1
Category _Clinical Operations, Project Management ... management is appropriately involved with key studies.
Identifies, responds to, and meets the needs of
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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educates team members on the PK/PD aspects of the projects.
May be requested to conduct other project-related tasks under the company’s drug development management structure and applicable FDA/ICH guidelines
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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all facing illness.
The Senior Director, Portfolio Management will lead the strategic planning ... .
Responsibilities
Develop and implement R&D portfolio management strategies to maximize the value of the
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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, investigative, and creative problem-solving skills
Excellent time and project management skills ... operational excellence (third-party partners include event planning and management; website registration
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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functional / corporate project-based work Perform other departmental duties as assigned ... management and general administration
Ability to prioritize work assignments
Competency in Windows
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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and/or data management.
Working knowledge of sales targeting/segmentation, sales force sizing ... plan design across all stages of product lifecycle (launch vs. mature brands)
Demonstrated project
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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or area assigned to support.
Support functional / corporate project-based work Perform other ... practices of organization, planning, records management and general administration
Ability to
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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Serves as internal project lead to establish and execute payer initiatives in collaboration with ... field-based Market Access Account Management experience with a proven track record in access and
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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cross functional teams (Biostatistics, Clinical Operations, Data Management, Regulatory, PK/ADME ... for presentation of results and updates of projects at department, project, corporate and scientific
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Mitsubishi Chemical Group
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Jersey City, New Jersey
...
/project management strengths with ability to multitask while consistently meeting deadlines ... efficiently move documents towards final regulatory submission. Provides overall management, quality control
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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R&D and project management experience.
Solid knowledge of transactions especially in late-stage
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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programs (e.g., CRM, Salesforce (Veeva), etc.)
Administers MDM & Asset Management solutions (e.g ... management.
Takes cases through the Helpdesk ticketing system. Handles escalated level 2 and 3 cases
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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new product introduction including risk management. This role will be the quality subject matter ... Manufacturing ruling (21CFR part 4), and Device Risk
Management (ISO 14971).
Responsible for oversight
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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social media campaigns, including X (Twitter)/LinkedIn community management.
Required to travel 10
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Mitsubishi Chemical Group
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Jersey City, New Jersey
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, communicates the effects of these developments to management and the tax team and creates strategies to ... conduct operational audit based on senior management’s requirements.
Collaborates with accounting
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