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| Job #02984 |
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| About our client |
| Our client is a global leading pharmaceutical company based in Hanover, New Jersey. Their core business focuses on innovative pharmaceuticals and they are also a global leader in generics, vaccines and consumer health products. The company has strong financials, an experienced management team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up-to-date on current trends and best practices. This is a strong opportunity for someone that wants to put their drive and initiative to work! |
| Position |
Location |
| Clinical Supply Manager |
Hanover, New Jersey |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Plan, establish, manage and monitor activities related to clinical supplies, to support the drug development process (Phase I – IV) 2) Ensure clinical supply activity is performed in cooperation with internal and external customers as well as partners 3) Ensure clinical supply activity is in compliance with multinational regulations as well as the company’s internal procedures and GxP requirements 4) Lead complex studies requiring project management, IVRS, medication management and/or use of advanced simulation tools 5) Perform functional activities of the Clinical Supply Manager and perform project management activities from a clinical supplies perspective 6) Lead the planning, creation and maintenance of project supply plans (based on study forecasts) 7) Oversee the scheduling and timely delivery of bulk drug, label and packaging design, randomization, packaging, labeling as well as distribution of clinical supplies 8) Challenge and coordinate supply chain deliverables 9) Ensure that key project milestones are met 10) Negotiate and communicate supply plan timelines to internal as well as external customers and partners 11) Drive cross-functional activities (proactively) 12) Work with other line functions and external partners to manage complex projects 13) Perform supply forecast simulations 14) Contribute to the study specifications for IVRS studies and provide medication management for highly complex studies using IVRS 15) Maintain DSM project-specific budget and provide input to departmental budgets 16) Act as a representative on global project teams 17) Participate in capacity and resource planning |
| Requirements |
1) BS or equivalent (advanced degree in a scientific or relevant discipline preferred) 2) Minimum 5 years of relevant experience in pharmaceutical development, clinical development, clinical supply operations, project management or a related field 3) Recognized expert in clinical supplies 4) Proven track record of creativity and problem solving on projects 5) Knowledge of clinical supply systems and specialized tools 6) In-depth knowledge of relevant GxPs as well as applicable multinational regulations 7) Advanced knowledge of development activities and processes 8) Excellent organizational and planning skills 9) Good leadership and presentation skills 10) Superb project-management skills 11) Excellent communication, negotiation and interpersonal skills 12) Ability to work in interdisciplinary teams 13) Ability to strategically plan, organize and manage multiple projects simultaneously |

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