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

Overview

Certara :

Certara (CERT) is the largest and most comprehensive provider of strategic drug development, modeling & simulation and regulatory science services. We partner with biopharmaceutical businesses to optimize drug development decisions and accelerate the drug development process. At Certara, you will play an important role helping our clients develop new therapies and target unmet medical needs, expand the benefits of existing therapies to other populations, communicate scientific information in the language of regulatory success, balance risk profiles, differentiate drugs from a competitive perspective, and unlock millions in R&D savings. Ultimately, you'll be helping more critical drug products get to more patients.

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

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

Qualifications

Qualifications

Education, Experience, Training, and Knowledge :

2.4 Nonclinical Overview

Skills & Abilities :

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.