Job Listings

The Senior Manager, Computerized Systems Validation & Veeva Systems is responsible for the configuration and maintenance of Veeva Vault applications and for the validation oversight to ensure the compliance, integrity, and reliability of computerized systems within the organization. This encompasses day-to-day Veeva systems operational management and project leadership with a focus on configuring, 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 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...

The Associate Director/Director, Regulatory Affairs - Global Development Products (Anti-Viral), 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 role in ensuring alignment with company goals, regional requirements, and...

The IT Security Analyst will be responsible for supporting IT security operations. The position will provide technical analysis, guidance and hands-on delivery in the planning, implementation, and ongoing operations of IT security solutions. Will participate in technical research and development to ensure there is continuing enhancement of security.

The Manager/Sr. Manager, Clinical Business Operations will be responsible for clinical outsourcing and relationship management activities including: • Vendor selection (conducting Request for Proposal (RFPs) proposal review and analysis and budget negotiations, development and execution.) • Contract management throughout life cycle of study, setting of standards, cost savings development/tracking and budget management in support of the clinical development programs. • Assist with and provide support in developing effective clinical contractual agreements (such as Confidentiality agreements as...

The Senior Regulatory Operations Associate Contractor will lead in the preparation and submission of electronic regulatory documents through the FDA, EMA, MHRA, and HealthCanada Electronic Submission Gateways (ESG,), as well as prepare and file non-eCTD submissions, to ensure compliance with applicable laws and regulations.  The scope of this role includes formatting and publishing regulatory documents, managing document tracking and version control, archiving on- and off-site, maintaining a thorough understanding of regulatory requirements, collaborating with cross-functional teams, and identifying opportunities for process improvements.  In addition to these standard publishing...

The Field Medical Operations Coordinator is responsible for coordinating the administrative, operational support, and project management support to ensure functional and compliant conduct of the field medical team (MSLs). This includes planning, executing, monitoring, and reporting of MSL activities, systems, metrics, presentations, team scheduling, meeting planning, training coordination, and project tracking.

Shionogi is committed to incorporating the patient’s experience for a specific disease-state into its development programs. The voice of the patient, as it relates to concepts that matter to patients who are seeking care for treatment of a given medical condition, should translate into endpoints in a clinical trial that are being measured for inclusion in the regulatory label. The Director | Senior Director of COA Strategy Development & Implementation will be responsible to ensure assets across the pipeline have included the right COA instruments to support given patient-centered endpoints. The Food and Drug Administration (FDA) has stringent requirements for endpoints that are measured by COAs as evidenced by the 2009 FDA...

Shionogi is committed to incorporating the patient’s experience for a specific disease-state into its development programs. The voice of the patient, as it relates to concepts that matter to patients who are seeking care for treatment of a given medical condition, should translate into endpoints in a clinical trial that are being measured for inclusion in the regulatory label. The Director | Senior Director of COA Strategy Development & Implementation will be responsible to ensure assets across the pipeline, including assets focused on rare diseases, have included the right COA instruments to support given patient-centered endpoints. The Food and Drug Administration (FDA) has stringent requirements for endpoints that are...

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. This role will work closely with cross-functional teams to integrate antiviral 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...

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 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 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.