R&A - Principal Regulatory Writer (PRW) - Clinical

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 high quality documentation for regulatory submissions in order to help streamline the regulatory documentation process for our clients. The Principal Regulatory Writer (PRW) is a major contributor to document authorship for a variety of documents across different service lines. The PRW will be the project leader and authoring contributor for all types of client engagements, while mentoring others in the knowledge of authoring regulatory documents.

• 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)
• Serve as liaison and subject matter expert internally and for clients, guiding and advising them on strategies and best practices for achieving approval/agreement from regulatory authorities for all document types that Certara- Regulatory Sciences & Medical Affairs (RSMA) writes
• 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

• Bachelor's degree (minimum)
• 10+ years of regulatory writing experience or equivalent experience with clinical sections of the CTD such as:

• • 2.5 Clinical Overview
  • 2.7 Clinical Summaries
  • Clinical Study Reports
  • Clinical Study Protocols
  • Briefing Documents

• Understands regulatory requirements for different phases of development and different regulatory pathways
• Knowledge of global health authority requirements
• Collective experience writing and leading a range of documents in their entirety (e.g. study and submission level, pharmacovigilance)
• Strong understanding of the document creation process and of the drug development lifecycle
• Vaccine & Immunogenicity Regulatory Writing Experience is highly preferred

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 integrates this knowledge to deliver business successes and actively transfer this knowledge to strength the skill base across the organization

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.