R&A- Associate Principal Regulatory Writer- APRW (Clinical focus)

Certara

66d

About The Position

Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. Our goal is to enable the life sciences industry’s use of data, modeling, and analytics to make better decisions across the various phases of discovery and drug development. Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI resulting in significant opportunities to decrease the cost and increase the probability of success for new drug approval and commercialization. Regulatory Writers prepare high-quality documentation for regulatory submissions to help streamline the regulatory documentation process for our clients. The Associate Principal Regulatory Writer (APRW) is a major contributor to document authorship for a variety of documents across different service lines. The APRW will be the project leader and authoring contributor for all types of client engagements, while mentoring others in the knowledge of authoring regulatory documents

Requirements

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.
Ability 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 documents (e.g., Module 2), taking responsibility for clarity of purpose, leading others toward the common goal within the timeline and budget on complex projects.
Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making.
Demonstrate solid time management and other organizational skills.
Ability to develop professional relationships with clients as to further the business relationship and maintain current industry knowledge.
Ability to identify and institutionalize work practices that are most effective to ensure consistency in performance.
Ability to resolve problems that arise, particularly in sensitive or high-pressure situations.
Integrate this knowledge to deliver business successes and actively transfer this knowledge to strengthen the skill base across the organization.

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.