at Certara USA, LLC in Wilmington, Delaware, United States
Certara is hiring an Associate Principal Regulatory Writer to join our Synchrogenix Regulatory Services division!
Certara optimizes R&D productivity, commercial value, and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. In fact, since 2014, our customers have received over 90% of new drug and biologic approvals by the FDA.
As Certara's regulatory science division, Synchrogenix, a Certara company, assures and accelerates regulatory success through a unique combination of customized regulatory strategy, document authoring, medical communications and publications, and operations solutions. Synchrogenix's proven record of success is built on an unrivaled commitment to quality and compliance combined with the use of advanced technologies to enhance speed and efficiency.
Position Overview: Clinical Focus
Associate Principal Regulatory Writers are critical members of Synchrogenix's regulatory services team. They do more than prepare high-quality documentation for regulatory submissions; they help streamline the regulatory documentation process and provide strategic guidance and best practices for our clients. The Associate Principal Regulatory Writer (APRW) is a significant contributor to document authorship in various therapeutic areas and global markets. The APRW will be the project leader and authoring contributor for all types of client engagements while mentoring others to authorize regulatory documents.
What we offer:
Flexibility: The option to work remotely or in one of our global office locations
Recognition: Synchrogenix recognizes and celebrates the extensive experience and expertise our writers bring to regulatory submissions and product approvals.
Cutting edge technology: Upskill with advanced technologies that enhance speed and efficiency
Collaborative work environment: A team-based, collaborative approach to regulatory writing provides our writers with the support they need to deliver the highest quality work.
Comprehensive benefits: Competitive compensation, incentives, full benefits, and flexible paid time off (PTO)
Lead project teams and work closely with the client and internal and partner organization teams to develop strategies for organizing and preparing clinical regulatory documents. Duties include:
Authoring documents per client specifications, templates, style guides, per regulatory authority guidelines and requirements
Managing the budget for projects, including all contributors (writers, editors)
Ushering documents through the review process, conduct comment resolutions meetings (CRMs) and successfully lead a project team to consensus
Lead project-related meetings and teleconferences
Maintain collaborative, proactive, and effective communication with both client and internal teams
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
Requirements for the Role:
Bachelor's degree, minimum; advanced degree preferred
8+ years of regulatory writing experience with clinical-related documentation
Deep understanding of global regulatory requirements for different phases of drug development and different regulatory pathways
Experience in the development of clinical and submission-level documents
Mastery of Microsoft Word skills (editing tools, creating and modifying tables, and inserting figures) and document management techniques
Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making
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 strengthen the skill base across the organization
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.
New Haven, CT
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.