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Associate Principal Regulatory Writer, Non-clinical
2 settimane fa
**Job Overview**:
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.
**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 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
**Education, Experience, Training, and Knowledge**:
- 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
- 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 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 integrate this knowledge to deliver business successes and actively transfer this knowledge to strength the skill base across the organization
**About Certara**
Certara is a growing company that provides a novel and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies. The well-being of our employees is a priority at Certara, and that is why we support the most important aspects of their lives:
- Financial - competitive pay, incentives, retirement plans, income security programs
- Health and Wellness - comprehensive benefit package, wellness programs, healthy lifestyle office environments
- Work/Life - unlimited paid time off and an employee assistance program
- Growth & Development - performance driven environme
