R&A - Regulatory Writer II- Clinical focus

Certara USA, Inc.
United States, Pennsylvania, Wayne
4 Radnor Corporate Center (Show on map)
Apr 16, 2025
Overview About Certara Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries Regulatory Writers prepare highquality documentation for regulatory submissions in 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 lead a study-level document or serve as a back-up project lead. Responsibilities Responsibilities: Participate on project teams that may be led by more senior writers With minimal to moderate supervision, author documents per regulatory and client specifications, templates, style guides, and other guidance documents Lead project-related meetings with minimal support Understand how the hours/budgets affect tasks and how documents and projects are resourced Maintain collaborative, proactive, and effective communication with both client and internal teams Lead a comment resolution meeting 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 Qualifications Education, Experience, Training, and Knowledge: Bachelor's degree or higher, scientific discipline strongly preferred 1 to 3+ years of regulatory writing experience or equivalent experience Knowledge of a range of documents (some examples: investigator's brochures, protocols, clinical study reports, pharmacokinetic reports, observational and non-interventional reports, method validation reports, stability reports, plain language summaries, development safety update reports, periodic benefitrisk evaluation reports, and risk management plans) 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 Demonstrate effective written and verbal communication skills Demonstrate understanding of analyzing data and presenting them 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 and other organizational skills Show flexibility to meet project needs as required by deadlines and to meet corporate goals and objectives Remain knowledgeable of changes in the industry and adapt best practices 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, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.