R&A- Associate Principal Regulatory Writer- CMC focus

Certara USA, Inc.
United States, Pennsylvania, Wayne
4 Radnor Corporate Center (Show on map)
Mar 24, 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 to help streamline the regulatory documentation process for our clients. The Associate Principal Regulatory Writer (APRW) is a major contributor to document authorship for a variety of documents across different service lines. The APRW will be the project leader and authoring contributor for all types of client engagements, while mentoring others in the knowledge of authoring regulatory documents. Responsibilities Responsibilities: Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents Lead a project team and actively participate in the development and writing of high-quality documents (study-level and submissionlevel documents and pharmacovigilance documents) 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 collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful result Practice problem solving, taking broad perspectives in resolving issues to prevent negative impact to work Manage hours/budgets for their projects, including all contributors (writers and editors) Usher documents through the review process, conduct comment resolution meetings, and successfully lead a project team to consensus Maintain collaborative, proactive, and effective communication with both client and internal teams Lead project-related meetings Review documents and provide coaching to junior staff for studylevel and submissionlevel documents Ensure all assigned staff comply with client standard operating procedures and training requirements, as required Qualifications Education, Experience, Training, and Knowledge: Bachelor's degree or higher, scientific discipline strongly preferred 5 to 8+ years of regulatory writing experience with Chemistry, Manufacturing, and Controls documentation Experience in areas such as vaccines, gene/cell therapy, biologics, small molecule, manufacturing, analytical, or stability Experience with submissions such as NDAs, INDs, BLAs, or IMPDs Experience authoring and leading Modules 3 (e.g., Modules 3.2.S and 3.2.P) and Module 2.3 Understanding of regulatory authority guidelines and requirements and to anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance Ability to lead a project team Understand regulatory requirements for different phases of development and different regulatory pathways Knowledge of global health authority requirements Experience as a document lead in the development of submission-level 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 Ability to synthesize data across multiple data sources and documents to create summary reports Expertise to provide subject matter guidance for quality document preparation, document review, accurate comment resolution/incorporation, and document finalization Ability to own submission-level documents (eg, Module 3), taking responsibility for clarity of purpose, leading others toward the common goal within the timeline and budget on complex projects Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making Demonstrate solid time management and other organizational skills Ability to develop professional relationships with clients as to further the business relationship and maintain current industry knowledge Ability to identify and institutionalize work practices that are most effective to ensure consistency in performance Ability to resolve problems that arise, particularly in sensitive or high-pressure situations Integrate this knowledge to deliver business successes and actively transfer this knowledge to strengthen the skill base across the organization EEO 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.