• Request eCTD application numbers as needed from regulatory health authorities • Submit electronic submission via ESG or physical media • Provide technical direction for others • Prepare, compline, scan, render, and maintain regulatory submissions to regulatory health authorities • Prepare documents for electronic submission publishing by using MS Word formatting, content

As an member of our business development team, your work as Associate Director/Director of Business Development will involve identifying and building relationships with key decision makers both internally and externally. In this role, you will engage with potential customers to illustrate the competitive advantage that Synchrogenix brings through its regulatory strategy consulting, strategic cross

#LI JS1 Job Overview We have an immediate opening for a highly motivated and talented Senior PBPK Consultant and Scientific Advisor with a DMPK and PBPK modelling background. The candidate should have an in depth knowledge of the application of PBPK modelling in drug discovery and/or development and its acceptance across various regulatory bodies. The role involves leading consultancy projects wit

Location Work From Home in the US or from one of our office locations (Princeton, NJ) 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

Our Pharmacometricians are responsible for supporting quantitative decision making in drug development through the development and application of population PK, PK/PD, exposure response and other models. Qualified candidates will have the ability to work on a variety of therapeutic indications and data types and must be experts in applied Population PK, PK/PD, and/or exposure response modelling an

Design and drafts protocols for a broad range of pharmaco epidemiological observational or database studies utilizing real world databases including but not limited to Health Clinical databases, National Health Registries, Disease databases, etc. Conducts ad hoc literature reviews on real world evidence and related matters. Provides epidemiological input for CRF/eCRF development. Selects/reviews m

Functions as a subject matter expert, guiding and advising clients on strategies for achieving approval from regulatory authorities (e.g., pooling strategies, data presentation, regulatory responses) Leads multiple submissions concurrently (including more complex submissions) authoring, reviewing, overseeing budgets and timelines; developing submission plans/timelines including contingencies; prep

As an integral member of our Commercial business development team, your work as Director of Business Development will involve identifying and building relationships with key decision makers both internally and externally. In this role, you will engage with potential customers to illustrate the competitive advantage that Synchrogenix brings through its regulatory strategy consulting, strategic cros

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

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 o