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/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines. - Develop, implement and maintain the Management Plan ... according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. - Ensure collaboration across Regulatory & Site ...
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... demand forecasts and packaging plans so that packed clinical supplies are readily available in accordance with the project requirements - Initiate packaging campaigns with the assigned ... inventory is effectively managed - Create an appropriate distribution plan and have oversight of the assigned vendor(s) executing it - Ability to work independently and proactively to ...
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... scientific documents e.g. Investigational Medicinal Product Dossier, clinical trial justifications with minimum support of senior staff - May strategically plan and perform European ... , databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA). - Deliver regulatory training/presentations as required. - May perform additional tasks as ...
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... Product Dossier, clinical trial justifications - May strategically plan and perform European centralized submissions and facilitate global country submissions on complex studies or ... plans in line with agreed SOPs (customer and/or IQVIA). - Deliver regulatory training/presentations as required, internally or externally - May mentor junior colleagues and engage ...
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... operationalize the agreed upon approach. - Develop and/or support on the preparation of integrated study management plans in collaboration with the core project team. - Accountable for the ... . Take accountability for proactive contingency plans to mitigate risks. - Coach and/or mentor junior team members around project delivery, planning, project review, risk management and ...
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... requirements whilst ensuring optimization of supply plans - Provides operational oversight to assigned clinical supply chains to ensure the service meets all key milestones on-time, within ...
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... agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed. - Inform team members of completion of regulatory and ...
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, monitoring and close-out visits - Supporting the development of a subject recruitment plan - Evaluating the quality and integrity of site practices in accordance with regulatory ...
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... selection, initiation, monitoring and close-out visits - Supporting the development of a subject recruitment plan - Evaluating the quality and integrity of site practices in accordance ...
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The Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new ...
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Mit dem Klick auf “Job-E-Mail bestellen” stimmst du unseren AGBs, unseren Datenschutzbestimmungen und der Nutzung von Cookies zu. Du kannst dich jederzeit von unseren E-Mails & Services abmelden.