Principal Technical Editor, Regulatory Services (Deliverable Quality)

Overview About Certara 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. Responsibilities Responsible for understanding various services and leads the tactical and technical aspects: - Leads and organizes large quality control (QC) and document-level formatting projects.

- Recognizes deliverable quality issues and potential resolution, troubleshooting where necessary. - Competent in the technical side of document development (e.g., formatting and QC) and provides solution-driven responses to internal colleagues’ technical issues. - Supports the large-scale document workflow processes on submissions and/or other document management efforts, ensuring appropriate tracking methods are followed with appropriate communication practices.

- Works with documents to ensure compliance with appropriate guidelines and identifies those that are not compliant. - Thinks strategically about efficient execution of large-scale projects with multiple stakeholders. - Has a strong core understanding of the impact of their technical skills on all service lines. - Provides technical guidance to all engagements, including tactical support where needed to ensure the quality of the work remains strong.

- Troubleshoots for the team when submission-specific or systemic client issues arise, provides feedback to team members to improve productivity, and works across multiple areas to align the team members on expectations with the business goals. - Creates, owns, and continues to manage processes and strategies that offer efficiencies. - Able to manage the components of a regulatory submission, including client leadership, training, and communication; project and budget management; QC; style guide leadership; template and toolbar implementation; and appropriate training for all submission participants in all technical components.

- Serves as SME for deliverable quality, troubleshoot for internal/external teams when submission-specific issues arise as well as establish solution-driven response/processes to prevent them in the future. - Mentors others in document management responsibilities as well as appropriate client communication with respect to quality-related tasks, including technical specialization skills. - Identifies and drives improvements