Certara is the global leader in advancing modern, efficient drug development.
We provide proven modeling & simulation, regulatory and real-world value assessment software platforms and services. In partnership with our clients, we help reduce clinical trial burden, accelerate regulatory approval and increase patient access to medicines.
Synchrogenix, a Certara Company: Achieving Regulatory Success
As Certara’s Regulatory Science division, Synchrogenix accelerates the regulatory submissions of medical innovations worldwide through customized regulatory solutions, including strategy, communications, operations and technology. Synchrogenix is comprised of some of the most respected talent in the industry, including thought leaders, writers and editors, and regulatory submissions specialists. Our people are talented, quality-minded, and client and stakeholder-oriented.
Synchrogenix's people are at the core of our success, and our most successful people are:
- collaborative and value being part of a team
- experts with a thirst for continued learning
- consultative with an ability to articulate process and expertise
- deadline-driven and able to operate in a fast-paced environment
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.
- 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
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 Synchrogenix 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 is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.