Reference #: 1983
OverviewAbout Certara
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.
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 nonclinical 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.ResponsibilitiesResponsibilities
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
QualificationsQualifications
Bachelor's degree; MS or PhD preferred
8+ 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
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., nonclinical section [Module 2.6]), 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 wor 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 integrate 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.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.