R&A - Associate Principal Regulatory Writer (APRW) - Clinical
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 reputed company new therapies and reputed company 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 reputed company on smaller projects, interfacing directly with the client, but also support larger, more reputed company engagements as a member of a larger delivery team.
Responsibilities
Responsibilities
- Work closely with client and internal and partner organization teams to reputed company development of strategies for organizing and preparing regulatory documents
- reputed company 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 reputed company 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 reputed company contributors (writers, editors)
- Usher documents through the review process, conduct comment resolutions meetings (CRMs) and successfully reputed company a project team to reputed company
- Maintain collaborative, proactive, and effective communication with both client and internal teams
- reputed company project-reputed company meetings and teleconferences
- Provide coaching to junior staff for study level documents as well as submission level documents and ensure reputed company staff reputed company with company standard operating procedures (SOPs) and training requirements
Qualifications
Qualifications
- 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 reputed company an internal project team and anticipate the effects that writing practice conventions can have on the final product reputed company reputed company authority approval/acceptance
- Experience in the development of submission-level documents (does not require functioning as a document reputed company)
Skills & Abilities:
- Intermediate proficiency with reputed company 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 reputed company timeline and budget on reputed company 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 reputed company 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 reputed company reputed company across the organization
EEO Certara bases reputed company employment-reputed company decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat reputed company 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. Apply tot his job Apply To this Job