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: 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
The position can be located in any of our US based offices including, but not limited to: Cambridge, MA; Parsippany, NJ; Wilmington, DE; Nashville, TN; Raleigh, NC; San Diego, CA. Synchrogenix also allows for employees to fully work from home.
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 (APRW) is a major contributor to document authorship for a variety of documents across different service lines. The 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.
Synchrogenix is looking for individuals who have a depth of experience authoring clinical documents such as Investigator Brochures, Protocols, ISS, ISE, Clinical Overviews and more! If this is your area of expertise, apply today.
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, 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 ideas 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 all contributors (writers, editors)
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
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
Synchrogenix is proud to be an Equal Opportunity Employer and will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status, or any other characteristic protected by law. Synchrogenix makes reasonable accommodations for disabled employees and applicants. Synchrogenix only employs individuals with the right to work in the country/ies where the role is advertised. We are committed to fostering, cultivating, and preserving a culture of diversity and inclusion. The collective sum of the individual differences, life experiences, knowledge, inventiveness, innovation, self-expression, unique capabilities and talent that our employees invest in their work represents a significant part of not only our culture, but our reputation and achievement.
Education, Experience, Training, and Knowledge:
8+ years of regulatory writing experience with clinical related documentation
Understand regulatory requirements for different phases of development and different regulatory pathways
Knowledge of global health authority requirements
Experience in the development of submission-level documents
Skills & Abilities:
Intermediate proficiency with Microsoft 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 life cycle
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 within timeline and budget on complex 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 current 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 skill base across the organization
Internal Number: 1713
About Synchrogenix, a Certara Company
Synchrogenix...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.
Regulatory and Communications Strategy, Science, and Solutions:
As the largest consultancy of regulatory and medical writers in the industry, Synchrogenix is already a well-recognized, multi-disciplined provider of regulatory writing, operations, and communications services. Additionally, our innovative technology platform, which includes both the ClinGenuity™ Artificial Intelligence (A.I.) engine and the GlobalSubmit™ portfolio of electronic common technical document (eCTD) and regulatory information management (RIM) software, brings a unique end-to-end solution to our clients with the capability to transform the way we plan, create, deliver, and access and track information – all of which is essential to empowering decision-making for various stakeholders who are invested in healthcare research and innovation.