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
Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory approval process for our clients. The Senior Regulatory Writer (SRW) is a major contributor to document authorship for a variety of documents across different service lines. The SRW will be the project lead on smaller projects, interfacing directly with the client, but also support larger, more complex engagements as a member of a larger delivery team.
- Lead or participate in a project team which may be led by a Principal Regulatory Writer or Associate Principal Regulatory Writer
- Author documents per client specifications, templates, style guides, and other guidance documents
- Author documents per regulatory authority guidelines and requirements
- Act as client advisor, working with all parties to lead development of strategies for organizing and preparing regulatory documents
- Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work
- Manage budget for a low complexity project, including all contributors (writers, editors)
- Usher documents through the review process, conduct comment resolutions meetings (CRMs), and successfully lead a project team to consensus
- Maintain collaborative, proactive, and effective communication with both client and internal teams
- Lead or participate in project-related meetings and teleconferences
- Provide coaching to junior staff for study level documents
Education, Experience, Training, and Knowledge:
- Bachelor’s degree
- 3-5+ years of regulatory writing experience or equivalent experience with nonclinical, clinical, CMC, or pharmacovigilance related documentation
- Lead a project team, and actively participate in development and writing of high-quality documents (CTD Module 2.4 or 2.6 and submission level documents)
- Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance
- Experience in the development of submission-level documents (does not require functioning as a document lead)
- Experience in the development of pharmacovigilance documents
Skills & Abilities:
- Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques
- Strong understanding of the document creation process and of the drug development lifecycle
- Able to synthesize data across multiple data sources and documents to create summary reports
- Ability to conduct/lead a CRM and successfully lead a project team to consensus
- Ability to use logical arguments to persuade others when presenting ideas and suggestions, but also respond positively to opposing views voiced by others
- Develops professional relationships with clients as a way to further the business relationship and maintain current industry knowledge
- Ability to identify and institutionalize work practices that are most effective in order to ensure consistency in performance
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.