R&A - Associate Principal Regulatory Writer (APRW) - Clinical Focus

Certara:

Certara (CERT) is the largest and most comprehensive provider of strategic drug development, modeling & simulation and regulatory science services. We partner with biopharmaceutical businesses to optimize drug development decisions and accelerate the drug development process. At Certara, you will play an important role helping our clients develop new therapies and target unmet medical needs, expand the benefits of existing therapies to other populations, communicate scientific information in the language of regulatory success, balance risk profiles, differentiate drugs from a competitive perspective, and unlock millions in R&D savings. Ultimately, you'll be helping more critical drug products get to more patients.

Regulatory Writers prepare high-quality 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

• 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 submission-level 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 end 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 study-level and submission-level documents.
• Ensure all assigned staff comply with client standard operating procedures and training requirements, as required.

Qualifications:

• Bachelor's degree or higher, scientific discipline strongly preferred.
• 5 to 8+ years of regulatory writing 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
• 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.
• Possess broad experience and technical expertise across more than 1 therapeutic area.

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

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.