Full job description
Description:
This position provides technical leadership on Phase IV research support to the Global Lead, Center for Outcomes Research and Evaluation (CORE) within Medical Affairs in the strategic development, coordination and execution of RWE generation activities. Such activities include, but are not limited to, the development of strategic Phase IV research plans supporting key brand imperatives, the design of methodologically sound Phase IV study protocols to meet project objectives as well as the initiation and support of Seqirus-led, collaborative and sponsored research programs to ensure quality, time and budget deliverables are met. This position is also responsible for managing the supporting research staff, including direct reports and third party service providers.
A key function of this role is to lead the design and execution of Phase IV studies to generate real world evidence related to disease natural history, burden of disease, immunization-related coverage patterns, and other key behavioral factors.
This position is responsible for establishing and maintaining collaborative relationships with leading authorities, academic institutions and government entities focused on influenza vaccine Phase IV research.
Ultimately, this position supports the development of outcomes research that lead to peer-reviewed scientific publications and reimbursement dossier development.
This position is also responsible for participating in cross-functional discussions supporting the publication of CORE research through internal-facing education initiatives within Medical Affairs.
Responsibilities:
Assure regulatory compliance with internal procedures and external standards.
Submit documents to regulatory agencies, including regulatory agencies; assists with communication, negotiations and follow-up deliverables
Establish and maintain policies, guidelines, and procedures for the regulatory affairs department
Provide regulatory support on product development and project teams
Provide regulatory assessments for manufacturing design changes and validation activities
Review and approve test protocols to support regulatory submissions
Ensure product launches and distribution complies with applicable regulations
Provide regulatory input in quality management system, assessments, product development and compliance .
