at Certara USA, LLC in Wilmington, Delaware, United States
At Certara, we accelerate medicines to patients by partnering with life science innovators.
In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services. Our integrated and proprietary end-to-end platform with biosimulation, regulatory science, and market access solutions combined with our strong team of scientists and subject matter experts enable our clients to have:
informed decision-making & reduced clinical trial burden
higher R&D productivity
improved patient outcomes & increased patient access to medicines
accelerated regulatory approval
Certara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.
Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.
Synchrogenix, a Certara Company: 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 talented, quality-minded, and client and stakeholder-oriented.
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 Associate/Principal Regulatory Writer (PRW/APRW) is a major contributor to document authorship for a variety of documents across different service lines. The PRW/APRW 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 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)
8 to 10+ years of regulatory writing experience with 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... 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.