The Manager, Medical Communications is a key member of the Shionogi US Medical Affairs home office team and works to manage aspects of scientific publications and medical education on assigned products. This role manages the cross-functional and cross-regional medical communication teams in the strategic & tactical planning and implementation of assigned projects. This person is also a member of various cross-functional, global teams working across multiple projects, and serves as the point of contact for internal/external stakeholders with respect to medical communications.
We are seeking an experienced Senior Manager, GCP QA to join our team. This role is crucial for ensuring quality oversight of clinical studies and vendor programs, maintaining compliance with ICH GCP and FDA regulatory requirements, and upholding our high standards for data integrity. The ideal candidate will provide advisory and collaborate with clinical study teams and internal departments to assess and mitigate risks associated with vendors.
The Medical Science Liaison (MSL) is a field-based representative of the Medical Affairs Organization that supports and represents Shionogi Inc and its products with, and to, key opinion leaders (KOLs), clinicians, institutions, and professional organizations. This includes relationship building and management of KOLs providing for meaningful scientific exchange at national, regional and local levels in both academic and clinical practice settings. The incumbent addresses the specific needs of healthcare professionals (HCPs) by responding to unsolicited requests for information about our marketed and developing products.
As a clinical and scientific expert on the...
The Medical Science Liaison (MSL) is a field-based representative of the Medical Affairs Organization that supports and represents Shionogi Inc and its products with, and to, key opinion leaders (KOLs), clinicians, institutions, and professional organizations. This includes relationship building and management of KOLs providing for meaningful scientific exchange at national, regional and local levels in both academic and clinical practice settings. The incumbent addresses the specific needs of healthcare professionals (HCPs) by responding to unsolicited requests for information about our marketed and developing products.
As a clinical and scientific expert on the...
The Medical Science Liaison (MSL) is a field-based representative of the Medical Affairs Organization that supports and represents Shionogi Inc and its products with, and to, key opinion leaders (KOLs), clinicians, institutions, and professional organizations. This includes relationship building and management of KOLs providing for meaningful scientific exchange at national, regional and local levels in both academic and clinical practice settings. The incumbent addresses the specific needs of healthcare professionals (HCPs) by responding to unsolicited requests for information about our marketed and developing products.
As a clinical and scientific expert on the...
The Medical Science Liaison (MSL) is a field-based representative of the Medical Affairs Organization that supports and represents Shionogi Inc and its products with, and to, key opinion leaders (KOLs), clinicians, institutions, and professional organizations. This includes relationship building and management of KOLs providing for meaningful scientific exchange at national, regional and local levels in both academic and clinical practice settings. The incumbent addresses the specific needs of healthcare professionals (HCPs) by responding to unsolicited requests for information about our marketed and developing products.
As a clinical and scientific expert on the...
The Medical Science Liaison (MSL) is a field-based representative of the Medical Affairs Organization that supports and represents Shionogi Inc and its products with, and to, key opinion leaders (KOLs), clinicians, institutions, and professional organizations. This includes relationship building and management of KOLs providing for meaningful scientific exchange at national, regional and local levels in both academic and clinical practice settings. The incumbent addresses the specific needs of healthcare professionals (HCPs) by responding to unsolicited requests for information about our marketed and developing products.
As a clinical and scientific expert on the...
The Vice President, Government Relations is responsible for monitoring Government policies worldwide, identifying risks and opportunities, and influences policy to support Shionogi’s corporate interests. This role supports the development and implementation of Global Government Affairs strategy related to income generation and preservation, as well as goals that enhance Shionogi’s corporate reputation. This includes but is not limited to identifying opportunities from the US and other Governments for non-dilutive funding for R&D projects and procurement opportunities.
This role will provide administrative support to Commercial Teams (or as assigned) in all day-to-day processes including calendar management, contract management, meeting coordination, travel planning, processing expense reports, maintaining office supplies, and providing administrative and event logistic support as required. This role is pivotal in ensuring smooth operations and effective communication across teams and must have the ability to build and maintain professional presence and relationships, strong attention to detail, as well as excellent communication, organization and follow-up skills.
The Executive Director, Global Regulatory Affairs Therapeutic Area Leader- GTAL provides strategic oversight and direction for regulatory activities on a global and/or regional scale across one or more therapeutic areas. This role entails leading a multidisciplinary team in developing and executing regulatory strategies to advance our vaccine and antiviral product portfolio through all stages of development and commercialization within specific regions, such as the US, Europe, Asia Pacific...
The Senior Associate/Manager, Medical Information (contractor) will be responsible for timely dissemination of current, accurate, and balanced medical information to healthcare professionals and customers through various communication channels. This role is responsible for developing and updating scientific medical information content and will support the lead medical reviewer in promotional and medical review teams. The Sr. Associate/Manager, Medical Information (contractor) also requires proficiency with drug information databases and systems, as well as an understanding of Medical Information processes and procedures.
The Medical Director, Medical Affairs (COVID-19/Virology) – Evidence Generation 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 with focus on evidence generation and represent Medical Affairs at various cross-functional team meetings.
This Medical Director will have 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 Medical Director, Medical Affairs (COVID-19/Virology) – Medical Education 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 with focus on Medical Education and represent Medical Affairs at various cross-functional team meetings.
This Medical Director will have 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.
Reporting to the Senior Director, HEOR Strategy & Operations, the National Health Outcome Director serves as a scientific expert and a key point of contact between Shionogi and external stakeholders. The role involves communicating evidence-based information on the value proposition of Shionogi products, contributing to the understanding of health outcomes, and fostering collaborative relationships with healthcare professionals, payers, and other decision-makers.
Reporting to the Senior Director, HEOR Strategy & Operations, the National Health Outcome Director serves as a scientific expert and a key point of contact between Shionogi and external stakeholders. The role involves communicating evidence-based information on the value proposition of Shionogi products, contributing to the understanding of health outcomes, and fostering collaborative relationships with healthcare professionals, payers, and other decision-makers.
The Senior Director, Government Operations, is responsible for overseeing program management activities related to Shionogi’s US Government Contracts, including partnerships with agencies such as BARDA, NIH, and the Department of Defense (DOD). This role serves as a key liaison with government agencies, ensuring alignment on program deliverables, budgets, and compliance reporting. As a strategic leader, the Senior Director guides cross functional teams to successfully execute complex, multi-year agreements and fosters strong business relationships. This role requires deep expertise in managing government-funded pharmaceutical programs, exceptional operational and leadership skills, and a commitment...
The Senior Director, Government Operations, is responsible for overseeing program management activities related to Shionogi’s US Government Contracts, including partnerships with agencies such as BARDA, NIH, and the Department of Defense (DOD). This role serves as a key liaison with government agencies, ensuring alignment on program deliverables, budgets, and compliance reporting. As a strategic leader, the Senior Director guides cross functional teams to successfully execute complex, multi-year agreements and fosters strong business relationships. This role requires deep expertise in managing government-funded pharmaceutical programs, exceptional operational and leadership skills, and a commitment...
Shionogi Inc. (“Shionogi”) is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company with state-of-the-art research capabilities that has provided innovative medicines essential to people's health for over 145 years. Shionogi is one of Japan’s oldest pharmaceutical companies, with a presence in over 10 countries and annual global sales exceeding $3 billion.
In the U.S., Shionogi develops and commercializes pharmaceutical products that address unmet medical needs in therapeutic areas such as anti-infectives. Shionogi has...
The Senior Manager, Government Operations, Alliance Project Management will report to the Senior Director, Government Operations, Alliance Project Management and will support program management activities related to Shionogi and Qpex’s US Government Contracts, including partnerships with agencies such as BARDA, NIH, and the Department of Defense (DOD). This role serves as a liaison with internal teams, government agencies, ensuring alignment on program deliverables, budgets, and compliance reporting. The Manager coordinates efforts of cross functional teams to successfully execute complex, multi-year agreements and foster strong business relationships. This role requires experience working on government-funded pharmaceutical...
The Senior Manager, Government Operations, Alliance Project Management will report to the Senior Director, Government Operations, Alliance Project Management and will support program management activities related to Shionogi and Qpex’s US Government Contracts, including partnerships with agencies such as BARDA, NIH, and the Department of Defense (DOD). This role serves as a liaison with internal teams, government agencies, ensuring alignment on program deliverables, budgets, and compliance reporting. The Manager coordinates efforts of cross functional teams to successfully execute complex, multi-year agreements and foster strong business relationships. This role requires experience working on government-funded pharmaceutical...
The Principal Biostatistician takes a statistical leadership role in the methodological development of clinical projects and assists the Head of Biostatistics in managing the biostatistics team as appropriate. Independently and collaboratively works across global multi-disciplinary clinical study teams on both in-house and outsourced clinical trials. She/He will provide expert statistical support to the biometrics group, study and project teams and any other function that requires statistical input.
The Director of Meeting Planning works across all Shionogi US departments and has direct responsibility and oversight of the Meeting Planning function which includes the 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...
The Director, Professional Education Marketing holds the strategic role of developing and implementing initiatives to educate on and increase awareness of new pharmaceutical options for COVID-19 treatment and prevention among healthcare professionals. This role will also develop and manage partnerships with professional organizations and Key Opinion Leadersfor Ensitrelvir, an investigational antiviral agent being evaluated in patients with mild to moderate COVID-19 infection. This position requires a deep understanding of the pharmaceutical industry, promotional medical education, and the ability...
The 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 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. This role is expected to work closely with their respective Insights & Analytics (I&A) leads to ensure appropriate insights are transformed into standardized metrics and...
The AD/Director, Primary Market Research will support internal customers to identify market insights that effectively drive strategic decision-making and maximize the commercial potential of Shionogi portfolio. The incumbent is responsible for the design and execution of primary market research studies that assess market landscape, product performance and marketing and sales initiatives for both in-line and new products within covered therapeutic area. The current focus is across Infectious Diseases, including hospital anti-infectives and COVID-19.
The candidate must have demonstrated capability in all...
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 Senior 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 COVID portfolio (pre-commercialization).
The Director, Sales Training is responsible for designing, developing, and implementing, a comprehensive training program to onboard and prepare a new sales force for the successful launch of Ensitrelvir, a 3CL protease inhibitor and investigational oral antiviral agent being evaluated in patients with mild to moderate COVID-19 infection. This role will require strategic planning and development of pre-launch and launch training initiatives, new hire curriculum, and ongoing training to ensure the field force is fully equipped with the skills, knowledge, and confidence to achieve its objectives. The role encompasses developing and implementing training plans for the sales force, including first and second-line leaders...
Reporting into the Senior Director, Consumer Marketing, the Associate Director of Digital Marketing is responsible for developing and executing digital marketing strategies to promote and enhance the brand's online presence. This position requires a deep understanding of the pharmaceutical industry, digital media and marketing trends, social media platforms and ability to interpret and leverage reporting analytics insights.
The Sr. Manager/Associate Director Medical Communications is a key member of the Shionogi US Medical Affairs home office team and works to drive all aspects of scientific publications and medical education on assigned products. This role leads the cross-functional and cross-regional medical communication teams in the strategic & tactical planning and implementation of assigned projects. This person is also a member of various cross-functional, global teams working across multiple projects, and serves as the central contact for internal/external stakeholders with respect to medical communications.
The Senior Manager, Medical Information provides in-depth scientific knowledge expertise to handle medical information requests from healthcare professionals and customers. The role can serve as a therapeutic area and product expert for both internal and external customers. This role must also demonstrate an advanced level of knowledge of drug information databases and systems, and Medical Information processes and procedures. The Sr. Manager, Medical Information will contribute to the planning, development, and maintenance of scientific medical information content and projects, and will be responsible for timely dissemination of current, accurate, and balanced product information. This role will also provide support...
The ED/VP of Medical Science serves as the Global Medical Leader, overseeing compounds targeting neurodevelopmental (FXS, Jordan’s, etc) and CNS diseases and assuming the crucial responsibility of Medical Monitor for clinical studies. Responsibilities include providing comprehensive medical and scientific guidance, ensuring alignment of company clinical programs with the overarching Global Clinical Development Plan for assigned assets. Extensive interactions with Regulatory Authorities, including the FDA, as well as engagement with clinical experts, investigators and patient organizations, are integral to the role. Collaboration with functions such as Project Management, Regulatory...
Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company with state-of-the-art research capabilities that has provided innovative medicines essential to people's health for over 145 years. Shionogi is one of Japan’s oldest pharmaceutical companies, with a presence in over 10 countries and annual global sales exceeding $3 billion.
In the U.S., Shionogi Inc. develops and...
The Senior Director, Patient Advocacy will be responsible for developing a patient advocacy engagement strategy to define our cross-functional approach to working within the current and future therapeutic portfolio of Shionogi, focused primarily, but not exclusively on Rare Disease. This work includes strategic oversight, coordination, and implementation of patient advocacy and engagement programs as well as research and insights-gathering to support scientific evidence and patient outcomes aligned with corporate and brand strategy. This leader will coordinate with all internal constituents to ensure a 360-degree level of engagement is achieved. From trial protocol design to patient access support, this...
The Associate Director, Marketing Operations will serve as the cross-functional operational lead for in-line and pre-launch brands including Ensitrelvir, an investigational oral antiviral agent being evaluated in patients with mild to moderate COVID-19 infection, and have responsibility for coordinating and managing related processes, launch readiness, and communications. The role will also coordinate and develop internal Brand plan and launch readiness presentations, orchestrate key cross-functional meetings, and conduct commercial/marketing analysis as needed.
The Associate Director, Product and Corporate Communications will report to the Senior Director, Corporate Communications and will lead the development and implementation of integrated Product and Corporate Communications. The individual in this role must be highly collaborative, have experience in the biotech or pharmaceutical industry, have a strong desire to be part of a growth culture, and have proven ability to drive effective communications strategies and programs.
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.
KAMs are responsible for calling on a variety of targeted healthcare professionals within the institutional setting,...
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.
