at Certara USA, LLC in Wilmington, Delaware, United States
Certara company overview: Certara is the global leader in advancing modern, efficient drug development.
We provide proven modeling & simulation, regulatory and real-world value assessment software platforms and services. In partnership with our clients, we help reduce clinical trial burden, accelerate regulatory approval and increase patient access to medicines.
Synchrogenix, A Certara Company overview: Achieving Regulatory Success
As Certara's Regulatory Science division, Synchrogenix accelerates the regulatory submissions of medical innovations worldwide through customized regulatory solutions, including strategy, communications, operations and technology. Synchrogenix is comprised of some of the most respected talent in the industry, including thought leaders, writers and editors, and regulatory submissions specialists. Our people are client and stakeholder-oriented, talented and quality-minded.
Synchrogenix's people are at the core of our success, and our most successful people are:
collaborative and value being part of a team
experts with a thirst for continued learning
consultative with an ability to articulate process and expertise
deadline-driven and able to operate in a fast-paced environment
Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory documentation process for our clients. The Principal Regulatory Writer (PRW) is a major contributor to document authorship for a variety of documents across different service lines. The PRW will be the project leader and authoring contributor for all types of client engagements, while mentoring others in the knowledge of authoring regulatory documents.
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, actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents)
Serve as liaison and subject matter expert internally and for clients, guiding and advising them on strategies and best practices for achieving approval/agreement from regulatory authorities for all document types that Synchrogenix writes
Author documents per client specifications, templates, style guides, and other guidance documents
Author documents per regulatory authority guidelines and requirements
Act as client advisor and proactive consultant to collaborate and anticipate the needs of the client based on the relationship and knowledge while looking for new business opportunities
Take ownership of entire deliverable (e.g. CMC section) that include multiple writers
Manage budget for all types of projects, liaise with finance and mentor others in fiscal responsibility and outcomes at the project level
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 and coach others in same
Provide coaching to junior staff for all documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements
Education, Experience, Training, and Knowledge:
Bachelor's degree (minimum)
10+ years of regulatory writing experience with clinical, non-clinical, CMC or pharmacovigilance related documentation
Understands regulatory requirements for different phases of development and different regulatory pathways
Knowledge of global health authority requirements
Collective experience writing and leading a range of documents in their entirety (e.g. study and submission level, pharmacovigilance)
Strong understanding of the document creation process and of the drug development lifecycle
Skills & Abilities:
Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques
Able to synthesize data across multiple data sources and documents to create summary reports
Practice blameless problem solving, effectively managing all crisis communications, managing risks, and realizing business opportunities
Ability to communicate difficult and complex ideas clearly and effectively to all stakeholders
Ability to lead submission-level sections (e.g., nonclinical section [Module 2.6]), taking responsibility for clarity of... For full info follow application link.
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.