Associate Principal Regulatory Writer- Clinical focus at Certara

Job Overview

Regulatory Writers prepare high quality documentation for regulatory submissions in order 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

• 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 development and writing of high-quality documents (study-level and submission level documents, 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 end result
• 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 project-related meetings and teleconferences
• Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements

Education, Experience, Training, And Knowledge

• Bachelor’s degree
• 8+ years of regulatory writing experience as lead author with clinical-related documentation
• Understand regulatory requirements for different phases of development and different regulatory pathways
• Knowledge of global health authority requirements
• Experience 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
• Able 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 sections (e.g., clinical section Module 2.7), taking responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects
• Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making
• 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
• Ability to resolve problems that arise, particularly in sensitive or high-pressure situations
• Possesses broad experience and technical expertise across more than one therapy area and integrate this knowledge to deliver business successes and actively transfer this knowledge to strength the skill base across the organization