Overview:The Senior Technical Editor (TE) is a leader in the document quality service line who is responsible for performing the necessary duties of TEI and TEII 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. The Senior TE has also specialized in providing technical support to a service line outside of Document Quality. Responsibilities:
Lead and provide strategic insight on document-quality related tasks including but not limited to:
Quality control reviews
Using Word features/functions
Using internal/client templates/toolbars
Liaise with KAMs
Document level publishing
Proficiency in techniques to be able to offer services and proactively resolve issues to a client directly in more complex engagements (as a super user or client lead)
Proficient understanding of lead activities specific to the technical aspects of a service line other than Document Quality; can lead independently
Proficient understanding of the requirements for submission-ready documents and the submission structure; has a proficient understanding of the guidance that dictates the placement of documents in the submission
Create, maintain, and organize client-specific guidance, templates, technologies, and preferences
Mentor others regarding all document quality services as well as client communication with respect to quality related tasks
Achieves a standard of excellence towards building internal and external relationships, delivery of service, and accountability with projects
Qualifications:Education, Experience, Training, and Knowledge:
Bachelor’s degree in English, Journalism, scientific discipline or related field with an interest in regulatory writing
ELS certification desired, but not required
Strong computer skills, including proficiency with MS Office and Microsoft Word functionality in terms of editing tools, creating and modifying tables and inserting figures
3 or more 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, eCTD, and AMA style guidance and version control, Word template
Proven success in team-based environment
Skills & Abilities:
Proficient understanding in Certara processes that impact the quality service line
Understand the fundamental aspects of communication theory and practice
Is a self-motivated and solution driven team player who is flexible with an extremely high level of attention to detail and enjoys collaboration
Ability to work in a collaborative environment and be tolerant of some degree of ambiguity, easily build relationships with others
Ability to independently direct others to complete projects with a proactive approach and little need for detailed instructions
Demonstrate solid time management skills and is deadline conscious with strong leadership and management of process
Desires challenges, both technical and interpersonal
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.
