R&A- Senior Regulatory Writer- SRW (Clinical focus)

Overview

About Certara

Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.

Our goal is to enable the life sciences industry’s use of data, modeling, and analytics to make better decisions across the various phases of discovery and drug development. Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI resulting in significant opportunities to decrease the cost and increase the probability of success for new drug approval and commercialization.

Regulatory Writers prepare high-quality documentation for regulatory submissions to help streamline the regulatory approval process for our clients. The Senior Regulatory Writer (SRW) is a major contributor to document authorship for a variety of documents across different service lines. The SRW 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

• Lead a project team or participate in a project team that may be led by a Principal Regulatory Writer or an Associate Principal Regulatory Writer.
• 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 with all parties to lead development of strategies for organizing and preparing regulatory documents.
• Practice problem solving, taking broad perspectives in resolving issues to prevent negative impact to work.
• Manage hours for their projects, including all contributors (writers and editors).
• Usher documents through the review process, lead comment resolution meetings, and successfully lead a project team to consensus.
• Maintain collaborative, proactive, and effective communication with both client and internal teams.
• Lead or participate in project-related meetings.
• Provide coaching to junior staff for study-level documents, which may include reviewing work of more junior writers
  
  

Qualifications

Education, Experience, Training, and Knowledge:

• Bachelor’s degree or higher, scientific discipline strongly preferred.
• 3 to 5+ years of regulatory writing or equivalent experience with clinical related documentation 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).
• Experience in the development of pharmacovigilance 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.
• Demonstrate solid time management and other organizational skills.
• Ability to synthesize data across multiple data sources and documents to create summary reports.
• Ability to use logical arguments to persuade others when presenting ideas and suggestions but also respond positively to opposing views voiced by others.
• Develop professional relationships with clients 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.
  
  

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.