Certara · 2 hours ago
R&A - Associate Principal Regulatory Writer (APRW) - Clinical Focus
United States
Full-time
Remote
Senior Level, Lead/Staff
5+ years expCertara is a company that accelerates the potential of bringing medicines to market using biosimulation software and services. The Associate Principal Regulatory Writer (APRW) will lead the development of regulatory documents and mentor junior staff while ensuring compliance with regulatory authority guidelines and client specifications.
BiotechnologyHealth CarePharmaceuticalSoftware
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
Qualification
Required
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
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 strengthen the skill base across the organization
Company
Certara
Certara is a pharmaceutical company that accelerates medicines with biosimulation software and technology.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$844.17MKey Investors
Arsenal Capital PartnersMubadala
2025-03-28Post Ipo Equity· $5.67M
2023-08-29Grant
2022-11-07Post Ipo Secondary· $449M
Leadership Team
Daniel D. Corcoran
Senior Vice President and General Counsel
Rona Anhalt
Chief Human Resources Officer
Recent News
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2026-01-06
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2025-12-12
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