Sr Technical Editor

The Senior Technical Editor (TE) is a leader in the document quality service line who is responsible for performing the necessary duties of Technical Editor I and Technical Editor II as well as having a comprehensive understanding of the organization, organizational process, and structure of regulatory submissions to provide internal and client leadership. The Senior TE also demonstrates an understanding of customer needs and expectations and mentors junior colleagues.

Responsibilities:

• Demonstrates strong proficiency with all aspects of quality control review and document-level formatting, depending on business needs
• Proficient understanding of the requirements for submission-ready documents and submission structure and has a proficient understanding of the guidance that dictates the placement of documents in the submission for document management or publishing-related tasks, depending on business needs
• Demonstrates effective leadership for all document quality related tasks and services:
• Lead document quality-related projects
• Coordinate with all members of the project team to share project-specific information
• Manage the timeline and budget
• Communicate client feedback with the team
• Provide strategic insight and propose ways to improve performance on document quality related tasks
• Proactively and effectively manage budgets while communicating with key internal stakeholders
• Demonstrates clear and effective written and verbal communication, ensures actions align to applicable standard operating procedures, work instructions, and TE best practices, and remains in compliance to training and position standards
• Meets quality expectations and deliverables in daily performance; daily activities align with productivity goals; and responds positively to feedback and adjusts performance accordingly
• Creates, maintains, and organizes client-specific guidance, templates, technologies, and preferences
• Mentors more junior members regarding all document quality services as well as client communication with respect to quality related tasks in collaboration with managers and other stakeholders of the team
• Sets specific goals when training others, monitors others' performance results, recommends solutions to challenges in achieving project expectations, and shares ideas to enhance career and business goals
• Contributes meaningfully to internal initiatives, QC qualification processes, and/or other efforts to improve the organization's quality
• Perform other duties as required by the business

Qualifications:

• Bachelor's degree in English, journalism, scientific discipline, or related field with an interest in regulatory writing
• 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) in terms of editing tools, creating and modifying tables, and inserting figures
• At least 3 years of prior related experience; highly skilled, talented, and motivated candidates will be considered
• Background in pharmaceuticals and/or science and technical industries is preferred
• Understanding of GXP, ICH E3, electronic Common Technical Document (eCTD), AMA style guidance, version control principles, and MS Word template usage
• Proven success in team-based environment

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
• Proficient understanding of Certara processes that impact the document quality service line
• Understands the fundamental aspects of communication theory and practice
• A self-motivated and solution driven team player who is flexible with an extremely high level of attention to detail and enjoys collaboration
• Gives timely, specific, and constructive feedback and confronts performance directly with support from the manager; answers team member questions regarding process for accomplishing work and performance standards; allows team members discretion in choosing appropriate methods for completing work; acts as an advocate/subject matter expert for team-related tasks/projects, and develops the trust of senior members based on consistent performance
• Takes ownership of the project within own area of expertise, coordinating with all members of the project team, managing the timeline and budget for their project components, and interfacing with finance when requested
• Understanding of scientific methodology with ability to understand clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
• Possesses knowledge of ICH and GXP guidelines and technical knowledge of US, CA, and EU eCTD submission requirements
• Achieves a standard of excellence towards building internal and external relationships, delivery of service, and accountability with projects
• Able to independently direct others to complete projects with a proactive approach and little need for detailed instructions
• Demonstrates solid time management skills and is deadline conscious with strong leadership and management of process
• Can manage changing and competing priorities in a fast-paced environment

Certara bases all employment-related decisions 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.