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 and/or initiatives in efficiency, quality, and productivity by establishing and/or modifying processes, standard operating procedures, and guidelines.

- Builds strategic relationships within the company and with business partners, vendors, and key external thought leaders to drive alignment and transparency.

- Liaises with business development as an SME for all deliverable quality services and participates in new opportunities.

- Identifies key priorities and expresses need for employees to take account of these priorities.

- Identifies solutions that are not obvious to others and not learned from previous education or experience to explain the situations or resolve the issue.

- Conceptualizes, leads, and/or meaningfully contributes to internal initiatives, training and qualification of QC staff, and/or other efforts to improve the organization’s quality.

- Perform other duties as required by the business.

Qualifications

· Bachelor’s degree in a scientific discipline, English, or related field.

· At least 7 years of prior related experience in pharmaceuticals and/or science and technical industry part of which is specific to editing, document management, project management, regulatory operations, or transparency and disclosure.

· Editor in the Life Sciences certification desired but not required.

· Strong computer skills, including proficiency with Microsoft Office Suite (e.g., Outlook, Word, Excel, and PowerPoint) and Adobe products.

· Technical knowledge of US, CA, and EU eCTD submission and redaction requirements.

· Proven success in a team-based environment, providing leadership and strategic counseling of multiple teams to maintain alignment across a project.

Skills & Abilities:

· Able to work in a collaborative environment and be tolerant of differences in culture and beliefs, easily build relationships with others, openly share information, and willingly contribute toward accomplishment of team goals.

· Able to be comfortable with some degree of ambiguity, easily build relationships with others, supporting all team members where possible.

· Maintains knowledge of trends in the industry through relationships with key players, conference attendance, and involvement and interaction with regulators.

· Provides colleagues with the opportunity to achieve results and publicly acknowledges effective performance.

· Proficient understanding with Certara’s processes that impact all service lines.

· Understands the fundamental aspects of effective communication theory and practice to resolve conflict and utilizes strategies to persuade others in sensitive situations.

· Able to proactively identify projects and can operate with little need for detailed instructions or oversight, ensuring to think about the end results to determine the correct course of action.

· Exemplifies the fundamental aspects of communication theory and practice.

· Communicates clear, concise, and relevant information in an appropriate business format.

· Action and detail oriented, always seeking new development opportunities to build knowledge and skills.

· Demonstrates solid time management skills in a role that demands strong attention to detail and organizational skills in a fast-paced and challenging environment.

· Shows flexibility to meet project needs as required by deadlines and meets corporate goals and objectives

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.