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Certara
Budapest, Hungary; Krakow, Poland
Source: Certara careers · View original posting
From Certara's posting. “We” and “our” refer to the employer.
Overview
Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.
Our goal is to enable the life sciences industry’s use of data, modeling, and analytics to make better decisions across the various phases of discovery and drug development. Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI resulting in significant opportunities to decrease the cost and increase the probability of success for new drug approval and commercialization.
The Principal Technical Editor (PTE) is a senior leader in Regulatory Services (Deliverable Quality) who leads complex projects, speaks confidently as a subject matter expert (SME) for deliverable quality both internally and externally, and is able to adapt to novel projects independently. The PTE is a strong, independent, strategic thinker, an effective mentor, and a proactive employee who possesses strong communication and delegation abilities with the capacity to oversee the work of an entire team.
The PTE should be able to independently manage large and complex projects that involve various components of clinical development process and collaborate with other leaders in the organization to come up with productive solutions for our clients. The PTE should have a comprehensive understanding of the organization, organizational process, and structure of regulatory submissions to provide internal and client leadership. The PTE is expected to be exemplary at all duties of the lower TE grades.
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