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2003- Sr. Regulatory Writer- Non-Clinical Focus

at Certara USA, LLC in Wilmington, Delaware, United States

Job Description

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.

 

Job Overview:

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.

Responsibilities:

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

ADME 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

 

OTHER INFORMATION:

Number of Employees Supervised: [none/#]

Percentage of Travel Required:[X]%

Special Requirements:

Location: Remote

 

 

 

#LI-HM

 

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.        

 

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Job Posting: 845008

Posted On: Sep 16, 2021

Updated On: Oct 16, 2021