at Certara USA, LLC in Wilmington, Delaware, United States
Certara is hiring a Senior Regulatory Writer to join our Synchrogenix Division! This position can be based out of any US Certara office, or full time remote.
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 documentation process for our clients. The Regulatory Writer II (RW II) is a major contributor to document authorship in support of senior writers in the creation of a variety of documents across different service lines. The RW II may serve as backup project lead, having written sections of regulatory documents.
Participate on project teams that may be led by a Principal Regulatory Writer, Associate Principal Regulatory Writer, or Senior Regulatory Writer
Author documents per client specifications, templates, style guides, and other guidance documents
Experience in the development of clinical documents such as Clinical Study Reports, Investigator Brochures, protocols ISS and/or ISE
Lead project-related meetings; lead a study-level document, understand how the budget affects the tasks and how resourcing works
Maintain collaborative, proactive, and effective communication with both client and internal teams
Lead a comment resolution meeting (CRM) with little support, complete appropriate preparation documents and compile appropriate follow-up responses
Understand and adhere to constraints of budgets and tasks as provided by project leads
Education, Experience, Training, and Knowledge:
1-3+ years of regulatory writing experience or equivalent experience
Knowledge of a range of documents (some examples: investigator's brochures, protocol, CSR, pharmacokinetic reports, observational and non-interventional reports, method validation reports, stability reports, lay summaries)
Possess an understanding of the drug development process
Possess technical regulatory knowledge to understand client technical requirements and needs
Skills & Abilities:
Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques
Understand the fundamental aspects of communication theory and practice; demonstrate an understanding of analyzing data and presenting in a written format.
Effectively build support and consensus in support of a quality work product
Communicate clear, concise, and relevant information in a professional manner
Ability to work in a collaborative environment, openly share information, and willingly contribute toward accomplishment of team goals
Action and detail oriented, always seeking new development opportunities to build knowledge and skills
Demonstrate solid time management skills
Show flexibility to meet project needs as required by deadlines and meet corporate goals and objectives
Remain knowledgeable of changes in the industry and adapting best practices
Number of Employees Supervised: 0
Percentage of Travel Required:[X]%
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,... For full info follow application link.
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.