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 in order to help streamline the regulatory approval process for our clients. The Associate Principal Regulatory Writer (APRW) is a major contributor to document authorship for a variety of clinical documents across different therapeutic areas. The APRW will be the project lead on smaller projects, interfacing directly with the client, but also support larger, more complex engagements as a member of a larger delivery team.

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

Qualifications

• Education, Experience, Training, and Knowledge:

  • Bachelor's degree; MS or PhD preferred
  • 5-8+ 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
  • Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance
  • Experience in the development of submission-level documents (does not require functioning as a document lead)

  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.