Click column header to sort
Responsible for overseeing and managing insourced or outsourced studies including all operational aspects of assigned phase I – IV clinical trial(s), whilst ensuring patient safety, data quality and integrity.
The Senior Manager, Regulatory Affairs - GDP - 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 Associate Director, Regulatory Affairs – GDP Contractor, provides essential support to the Executive Director in overseeing regulatory activities related to antiviral 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 will work closely with cross-functional teams to integrate antiviral considerations into product development, manufacturing, and commercialization processes. This position plays a pivotal...
The Senior Manager, Computerized Systems Validation & Quality Assurance is responsible for validation oversight to ensure the compliance, integrity, and reliability of computerized systems within the organization. This encompasses day-to-day operational management and project leadership with a focus on authoring, review, approval of system validation, infrastructure qualification documentation, and execution of protocols where applicable, in accordance with pharmaceutical industry regulations, guidelines, GAMP, latest industry practices and Shionogi processes.
The Medical Operational Excellence Lead is responsible for driving continuous improvement initiatives, ensuring high standards of operational performance, ensuring Medical Affairs strategic projects are coordinated and executed timely, and fostering a culture of excellence within medical and clinical operations. This role involves collaborating with cross-functional teams to streamline processes, enhance productivity, and implement best practices, particularly but not exclusively in the area of field medical excellence, medical insights process, medical education development, and adopting innovative approaches to enhance impact and create efficiencies.
The Senior Medical Director, Medical Affairs (Virology/COVID-19 ) will provide medical/scientific support for relevant Shionogi products by functioning as a medical subject matter expert. Will lead the strategic and tactical planning for relevant products, and represent Medical Affairs at various cross-functional team meetings.
This Senior Medical Director, Medical Affairs will have primary responsibility for the Virology/COVID-19 disease portfolio, with the flexibility to expand into other product areas as needed and as Shionogi Inc. continues to grow.
The Director/Senior Director of Field & Marketing Operations is responsible for the leadership of the multiple functions supporting the Field Sales, Market Access, Marketing, and Medical Affairs teams. This individual will be focused on how to optimize the execution of our field forces, as well as provide key insights from the field into the business.
The Director/Senior Director of Field & Marketing Operations will support the field teams in developing key reporting and various tools to enable teams to effectively understand business trends and maximize sales potential. This role is expected to work closely with their respective Insights & Analytics...
The Meeting Planner works across all Shionogi US departments and has the responsibility of oversight, execution, and management of all Shionogi non-HCP, internal (onsite) and external (off-site) meeting planning activities.
This individual will bring subject matter meeting and event planning expertise to Shionogi US, with responsibilities including both individual management of events as well as management of vendors (when appropriate) to ensure seamless execution of larger events, managing each meeting’s budget, and executing each program on-time and within budget while ensuring events, meetings, and activities are compliant. This role requires significant...
The Associate Director performs business-driven analyses that generate in-depth customer-focused insights and enables critical discussions to continue. This individual will support key business decisions and inform company strategy through thoughtful analysis and projects, as well as support the Director of I&A in all business priorities. The role will also interface with the field-focused teams and home office closely in leading and developing the quarterly business review process.
This role will provide and generate insights and analytics for the US hospital-based portfolio at Shionogi, Inc with a focus on the in-line brand Fetroja™...
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...
The Documentation Specialist will support the Regulatory Operations team with the preparation of submission related documentation for electronic submission. The scope of this role includes assisting in document formatting, remediation and quality control (QC) of documentation for submissions to Health Authorities. The ideal candidate for this position will have experience in Microsoft Word, Adobe Acrobat, and Veeva RIM.
The Director/Senior Director performs and oversees business-driven analyses that generate in-depth customer-focused insights and identifies key business opportunities aimed at maximizing the commercial potential of the Shionogi portfolio. This individual will drive critical business decisions and inform company strategy through insightful analysis and external/industry experience.
This role will lead and generate insights and analytics for the US launch brands and pipeline opportunities across the anti-infectives and anti-viral portfolio, including COVID-19.
The KAM position is focused on establishing access and demand and access for a novel hospital antibiotic product to hospitals and hospital systems within an assigned territory. This includes educating formulary decision makers, key stakeholders, and clinicians on the clinical benefits of the product and establishing and gaining formulary adoption within the institutional IV antibiotic space. The KAM will be responsible for formulary access and sales at the top institutions in the U.S.
The KAM position is focused on establishing access and demand for a novel hospital antibiotic product to hospitals and hospital systems within an assigned territory. This includes educating formulary decision makers, key stakeholders, and clinicians on the clinical benefits of the product and establishing and gaining formulary adoption within the institutional IV antibiotic space. The KAM will be responsible for formulary access and sales at the top institutions in the U.S.
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...
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.
