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Location US-NJ-Florham Park
ID 2024-2176
The IT Security Analyst will be responsible for effective provisioning, operation, installation, configuration, and maintenance of IT security. The position will provide technical support, guidance and hands-on delivery in the planning, implementation, and ongoing operations. Will participate in technical research and development to ensure there is continuing enhancement of security.
Category
Information Technology
Position Type
Regular
Job Location
Hybrid
Location US-NJ-Florham Park
ID 2024-2134
The 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.
Category
Regulatory
Position Type
Regular
Job Location
Hybrid
Location US-NJ-Florham Park
ID 2024-2127
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...
Category
Regulatory
Position Type
Regular
Job Location
Hybrid
Location US-NJ-Florham Park
ID 2024-2106
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 Shionogi Inc. in global workstreams to ensure consistency across regions.
Category
Clinical Development
Position Type
Regular
Job Location
Hybrid
Location US-NJ-Florham Park
ID 2024-2104
The Senior Director, Clinical Operations holds accountability for developing strategic objectives and overseeing the tactical implementation of global or regional clinical programs for the rare disease franchise, aiming to deliver high-quality products and ensure business success for Shionogi in the marketplace. This pivotal role involves providing input to the leadership team on global strategies and functional initiatives with financial implications for organizational performance. Additionally, the Senior Director directly manages teams and provides oversight and mentoring to project team members. Responsibilities encompass aligning clinical programs with organizational goals and regulatory requirements, fostering cross-functional collaboration, managing risks, engaging...
Category
Clinical Development
Position Type
Regular
Job Location
Hybrid
Location US-NJ-Florham Park
ID 2024-2103
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.
Category
Business Development
Position Type
Regular
Job Location
Hybrid
Location US-NJ-Florham Park
ID 2024-2088
The Senior Director, Global Commercial Lead (GCL) - Anti-Virals /Antibiotics will work closely with our Japanese Leadership to shape product development plans, as we strive to be a leader in novel anti-infectives that includes anti-virals and antibiotics. The primary role will focus on the COVID portfolio and secondary area of focus will be to support the antibiotic portfolio.As Global Commercial Lead you will lead cross-multifunctional teams dispersed across Japan, US and Europe. You will lead development of globally aligned strategies, optimizing the life cycle of the product by providing global perspective and strategic direction at each step of the R&D process to improve decision making and gain an overall competitive advantage in the marketplace.
Category
Business Development
Position Type
Regular
Job Location
Hybrid
Location US-NJ-Florham Park
ID 2024-1789
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.
Category
Regulatory
Position Type
Regular
Job Location
Hybrid
Location US-NJ-Florham Park
ID 2024-1631
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, Japan [SHQ]; Florham Park, New Jersey [SI]; and London, England [SEU/SBV]) cross-functional team members including Medical Affairs, HEOR, Clinical Development, Regulatory, Market Access, Commercial teams and external collaborators/vendor...
Category
Business Development
Position Type
Regular
Job Location
Hybrid