at Certara USA, LLC in Wilmington, Delaware, United States
Certara is hiring an 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.
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.
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)
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 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
Requirements for the Role:
Bachelor's degree, minimum; advanced degree preferred
10+ 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... 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.