The Senior Promotional Review Associate will oversee all aspects of the commercial US Review Committee (USRC) process. This individual will serve as the primary contact for the promotional review process and work as a liaison between Commercial Leads, Reviewers, and Agencies for assigned products. Responsibilities also include identifying best practices, guiding short- and long-term planning, improving process efficiencies, and stakeholder training. Reporting to the Senior Director, USRA Advertising and Promotion, the Senior Promotional Review Associate will be a critical member of the USRC and strategic partner for the review and approval process.
This rolewill support in the preparation and submission of electronic regulatory documents through the FDA and Health Canada Electronic Submission Gateways (ESG), as well as, prepare and file non-eCTD submissions to ensure compliance with applicable laws and regulations. This includes publishing regulatory documents, managing document tracking and version control, maintaining a thorough understanding of regulatory requirements, collaborating with cross-functional teams, and identifying opportunities for process improvement.
This role will lead the Regulatory Operations - Documentation Specialist team in overseeing the documentation processes within an organization, ensuring that all documents are accurate, compliant, and efficiently managed. This role involves leading a team of documentation specialists, improving documentation workflows, and ensuring regulatory compliance.
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 Director, Global Development Projects provides strategic oversight and direction for regulatory activities on a global and/or regional scale. 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...
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...
The Director of USRA Advertising & Promotion will be responsible for providing strategic guidance and leadership relating to promotional activities. The Director will have accountability for review and approval of all promotional and proactive medical materials for assigned marketed products, compounds in development, and disease education. A critical aspect of this role is to enable achievement of business objectives while ensuring compliance with applicable FDA regulations, guidance documents, and company policies. The individual will also serve as the primary liaison for leading interactions with the Office of Prescription Drug Promotion (OPDP) for assigned products. Additionally, the Director will help build the USRA Advertising & Promotion team...
The Senior Medical Information Associate is responsible for having in-depth scientific knowledge of Shionogi medicines and therapeutic area to respond to medical information requests from healthcare professionals, patients, and customers through various communication channels. This role develops, maintains, and disseminates current, accurate, and balanced product information to internal and external customers. The Senior Medical Information Associate will also support other medical information activities and cross-functional product teams, such as scientific conference support and...
The Director, National (GPO/Federal) Account Management is responsible for developing and implementing an integrated account strategy for obtaining and maximizing market access and reimbursement to support Fetroja, a novel anti-infective for cUTI and HAP/VAP infections, along with the launch of Ensitrelvir, a novel 3CL protease inhibitor for the treatment of post exposure prophylaxis (PEP) for SARS-CoV-2 infection in the US and Zatolmilast, an investigational, rare disease treatment for Fragile X Syndrome. This position will also have accountability for securing access across key GPO and federal channels along with leading cross functional efforts to maximize pull through opportunities. ...
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...
Reporting into the Senior Director, Consumer Marketing, the Associate Director of Consumer Marketing (Digital) 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.
Support the Regulatory Affairs (Executive Director) in developing and executing regulatory strategies for antiviral programs globally or within specific regions
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, National Account Management is responsible for developing and implementing an assigned, integrated account strategy for obtaining and maximizing market access and reimbursement to support the launch of Ensitrelvir, a novel 3CL protease inhibitor for the treatment of post exposure prophylaxis (PEP) for SARS-CoV-2 infection in the US and Zatolmilast, an investigational, rare disease treatment for Fragile X Syndrome. This position will also have accountability for critical downstream account access and regional pull through to ensure strategic access goals are met and maximized. Additional accounts to be assigned based on business need.
The dynamic nature of Shionogi’s portfolio will...
The Director, National Account Management is responsible for developing and implementing an assigned, integrated account strategy for obtaining and maximizing market access and reimbursement to support the launch of Ensitrelvir, a novel 3CL protease inhibitor for the treatment of post exposure prophylaxis (PEP) for SARS-CoV-2 infection in the US and Zatolmilast, an investigational, rare disease treatment for Fragile X Syndrome. This position will also have accountability for critical downstream account access and regional pull through to ensure strategic access goals are met and maximized. Additional accounts to be assigned based on business need.
The dynamic...
The Director, National Account Management is responsible for developing and implementing an assigned, integrated account strategy for obtaining and maximizing market access and reimbursement to support the launch of Ensitrelvir, a novel 3CL protease inhibitor for the treatment of post exposure prophylaxis (PEP) for SARS-CoV-2 infection in the US and Zatolmilast, an investigational, rare disease treatment for Fragile X Syndrome. This position will also have accountability for critical downstream account access and regional pull through to ensure strategic access goals are met and maximized. Additional accounts to be assigned based on business need.
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.
This position can be located anywhere on the West Coast.
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.
This position can be located anywhere on the East Coast.
The Global Executive Director Medical Affairs will shape and execute the strategic vision for Shionogi’s anti-viral portfolio. This role provides critical medical leadership and strategic direction to ensure the successful development, launch, and lifecycle management of our anti-infective products. The Executive Director will collaborate cross-functionally to drive the development and launch of our products, and support their ongoing lifecycle management, ensuring they meet the highest standards of medical and scientific excellence.
The Associate Director, Field Promotions holds the role of developing, implementing and optimizing field-based and omnichannel tactics to increase HCP awareness of a new pharmaceutical product for COVID-19. This role will also be responsible for developing impactful two-way communication streams with the field force and importantly, be the Plan of Action (POA) meetings champion – assuring all brand elements of launch and POA meetings are coordinated flawlessly. This position requires a thorough understanding of the...
The Executive Director, Global Real-World Evidence is part of the Clinical Development group and provides strategic oversight and direction for pre-launch RWE generation with a focus on supporting clinical trial designs and observational studies to generate innovative and new treatment approaches on a global and/or regional scale for assets in clinical development.
The candidate will be a thought leader with the technical skills to build...
The Manager, Commercial IT Systems will be responsible for effective provisioning, operation, installation/configuration and maintenance of applications for the Commercial business users. The incumbent will evaluate digital solutions such as marketing platforms, websites and sales applications, and provide technical support, guidance and hands-on delivery in the planning, implementation, and ongoing operation of Commercial systems, working with the other Shionogi IT teams.
This position will collect business requirements, document specifications, create project plans, configurations, test plans and capture results in order to share knowledge with the team and develop...
The Director, AI Architect plans, designs, performs the implementation of AI infrastructures and tools, educates users, optimizing AI technology integration to transform business processes and drive innovation effectively and ethically. The position will act as a project manager and be hands-on with system configurations, development, operations, and user education.
The Senior Manager will be responsible for the overall oversight of clinical studies, ensuring the quality and integrity of risk-based monitoring deliverables. This involves developing comprehensive QCO Plans in collaboration with Clinical Trial Managers (CTMs) to detail strategies for maintaining high standards in monitoring activities. The role encompasses supporting study risk assessments and defining RBQM study needs and strategies, which include determining the frequency and requirements for onsite versus remote monitoring activities, targeted SDV and SDR, and fostering constructive collaboration with cross-functional teams such as biometrics/data management, eTMF, and medical/safety monitoring.
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 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.
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) – 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.
This position can be located anywhere on the East Coast.
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 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 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...
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, 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.
