Job Listings

The Clinical Trial Associate (CTA), Clinical Operations - Contractor will support the clinical project team in the operational execution of clinical trials.

Reporting to the Senior Manager, IT Helpdesk, the Senior Helpdesk Technician is a specialized, hands-on technical role that is the first point of contact responsible for providing help desk support and training support to end users, ensuring quick and efficient problem resolutions in all areas of technology. The help desk support duties include but are not limited to, resolving computer, mobile device, and peripheral device related problems in supported areas as well as supporting new software platforms, evaluations, and escalations and ad hoc projects as required. The day-to-day workload in summary involves maintenance, upgrades, updates, coordination,...

The AD, Real World Data Analyst plays a pivotal role in our Real-World Data (RWD) and Analytics team. Reporting to the Executive Director this role collaborates closely with stakeholders across the organization to implement our strategic vision for the RWD pipeline and insights generations. The primary responsibilities include ensuring data governance, integrity, and security across the RWD platform, analyzing complex datasets to derive actionable insights, and championing the use of AI and machine learning techniques for enhanced data analysis. The AD, RWD Analyst supports the development and enhancement of our global RWD data platform, meeting stakeholder needs and adhering to data security standards. Additionally, it evaluates data...

The Regulatory Operations Document Specialist Contractor will focus on formatting documents based on Shionogi standards and support remediation efforts by bookmarking, hyperlinking, and performing quality control measures to ensure our work product is compliant with our electronic submissions. In addition this assignment will focus on providing general assistance to the Regulatory Affairs team as a whole whilst focusing on supporting Regulatory Operations.

The Principal Data Manager oversees and coordinates all Data Management (DM) activities ensuring compliance according to quality standards, regulatory requirements, and project budget from study start-up through study close-out and final reporting.   The key duties and deliverables of this position include collaborating with the Biostatistics, Clinical and Medical Affairs teams in all aspects of supervising the CROs by setting up, managing and completing trial databases and CRFs within timelines with the primary goal of ensuring data integrity.  

The Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to QOL initiatives. This role involves actively contributing to the development and execution of regulatory strategies, regulatory submissions, and collaboration with regional regulatory authorities. While providing valuable support to higher-level management, the Senior Manager focuses on executing regulatory tasks, ensuring compliance, and facilitating cross-functional collaboration to achieve successful outcomes for our QOL initiatives.

The Clinical Trial Associate (CTA), Clinical Operations will support the clinical project team in the operational execution of clinical trials.

The Associate Director/Director, a member of Shionogi’s Global Epidemiology and Real-World Evidence (GEE) team, is responsible for strategizing and generating real-world evidence using fit-for-purpose data to support global products at each stage of the product lifecycle. This position will report to the Executive/Senior Director, GEE and support strategy, execution, and communication of real-world evidence (RWE) and epidemiology tactics for both pipeline and launch products.   This role will also work closely with global and regional (Osaka,...

The Senior Director, Regulatory Affairs - GDP provides strategic oversight and direction for regulatory activities on a regional and/or global scale. This role entails leading a multidisciplinary team in developing and executing regulatory strategies to advance our vaccine and bacterial product portfolio through all stages of development and commercialization within specific regions, such as the US. Responsibilities include developing and implementing regulatory strategy, driving regulatory submissions, fostering collaboration with regional regulatory authorities, managing regulatory risks and opportunities, and providing strategic guidance to executive and senior leadership. The Senior Director will serve as a key advisor on regulatory matters, ensuring alignment with company goals,...

The Senior Director of Drug Development Project Management is accountable for providing project management and drug development expertise to global project teams within the rare diseases franchise. This role involves strategic development and execution of integrated product development plans to ensure alignment with organizational goals and objectives. Collaborating with cross-functional teams, the Senior Director oversees the planning, execution, and monitoring of drug development programs, ensuring they are completed on time, within budget, and in compliance with regulatory requirements.   Furthermore, the Senior Director represents...

The Senior Director, Global Commercial Lead (GCL) will work closely with our Japan HQ to shape product development plans and implement global commercialization strategies in multiple therapeutic areas. The GCL is a high visibility role to lead projects of considerable value to the organization. As GCL, you will direct and coordinate cross-functional teams dispersed across Japan, US and Europe to create value for Shionogi and the patients and caregivers we serve. You will lead formation, alignment and execution of global strategies, optimizing the life cycle of the product. This will be achieved by providing global perspective and strategic direction at...

The Associate Director/Director, Regulatory Affairs - GDP, provides essential support to the Senior Director in overseeing regulatory activities related to Quality of Life (QOL) initiatives on a regional and/or global scale. This role involves assisting in the development and execution of regulatory strategies, regulatory submissions, and fostering collaboration with regional regulatory authorities. The Associate Director/Director will work closely with cross-functional teams to integrate QOL considerations into product development, manufacturing, and commercialization processes. This position plays a pivotal role in ensuring alignment with company goals, regional requirements, and best practices to achieve successful outcomes for our QOL initiatives.