at Certara USA, LLC in Wilmington, Delaware, United States
At Certara, we accelerate medicines to patients by partnering with life science innovators.
In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services. Our integrated and proprietary end-to-end platform with biosimulation, regulatory science, and market access solutions combined with our strong team of scientists and subject matter experts enable our clients to have:
informed decision-making & reduced clinical trial burden
higher R&D productivity
improved patient outcomes & increased patient access to medicines
accelerated regulatory approval
Certara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.
Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.
Senior Regulatory Writers prepare high quality documentation for regulatory submissions in order 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 nonclinical documents across different therapeutic areas. 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.
Lead or participate in a project team which may be led by a Principal Regulatory Writer or 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 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 or participate in project-related meetings and teleconferences
Provide coaching to junior staff for study level documents
Education, Experience, Training, and Knowledge:
Bachelor's degree; MS or PhD preferred
3-5+ years of regulatory writing experience or equivalent experience with nonclinical sections of the CTD such as:
2.4 Nonclinical Overview
2.6 Nonclinical Summaries
Pharmacology or Toxicology Reports
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
Ability to conduct/lead a CRM and successfully lead a project team to consensus
Ability to use logical arguments to persuade others when presenting ideas and suggestions, but also respond positively to opposing views voiced by others
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
Number of Employees Supervised: [none/#]
Percentage of Travel Required:[X]%
Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.