The Associate Director HRIS and Operations will provide functional and technical expertise along with leadership to drive, maintain and optimize our HR Systems and Operations. This role will work closely and collaboratively with key stakeholders (HR Business Partners, HR Total Rewards, Finance & Accounting, Payroll, IT, Legal, Compliance, global HR, etc.) to identify opportunities for automation and reduction of manual processes. This is a hands-on role that will improve HR processes with the use of technology while maintaining compliance with all policies and procedures and federal and state regulations.
This role will lead in the preparation and submission of electronic regulatory documents through the FDA, EMA, MHRA, and Health Canada 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 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 improvements. In addition to these standard publishing requirements, the Senior Regulatory Operations Associate will bring project management skills and technical...
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 Associate Director, Field Force Technology & Operations will be responsible for managing all technology systems that are supported by Field Operations; inclusive but not limited to Veeva Vault Customer Relationship Management tool (including MyInsights/X-Pages, OpenData), Veeva Link, and CRM integrated reporting. Responsibilities to include but are not limited to: Configuration tasks, testing, implementation, changes and enhancements, maintenance, quality control, reporting, and training.
This incumbent will also be required to support adoption and effective use of the Veeva CRM systems by all new/existing levels of users...
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...
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 Regional Sales Director (RSD) is a second-line field sales leadership role accountable for building and leading a field-based sales team and managing all operations related to the sales force in a defined region of the US. The role will support the pending launch of ensitrelvir, for a novel 3CL protease inhibitor for the prevention of SARS-CoV-2 infection for the US as part of a new primary care sales team. It is projected that there may be approximately 2-3 RSDs nationwide, each responsible for approximately 50-75 sales representatives and 7-9 District Managers.
Reporting to the Head of Primary Care Sales, this role is accountable for setting strategic and tactical...
The Regional Sales Director (RSD) is a second-line field sales leadership role accountable for building and leading a field-based sales team and managing all operations related to the sales force in a defined region of the US. The role will support the pending launch of ensitrelvir, for a novel 3CL protease inhibitor for the prevention of SARS-CoV-2 infection for the US as part of a new primary care sales team. It is projected that there may be approximately 2-3 RSDs nationwide, each responsible for approximately 50-75 sales representatives and 7-9 District Managers.
Reporting to the Head of Primary Care Sales, this role is accountable for setting strategic and tactical...
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 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 Director of Global Portfolio Strategy will have two key responsibilities: 1) to lead strategic planning initiatives for selected early-stage projects in Shionogi’s Research and Development portfolio, 2) to partner with Global Portfolio colleagues in the implementation and optimization of portfolio analysis processes and effectively communicate project and portfolio information to senior executives in all Shionogi regions.
As the HRBP – Field Sales, you will be responsible for providing strategic and tactical HR support to the Commercial Sales organization, specifically our Primary Care Sales Team. Reporting to the Senior Director, Human Resources, you will serve as a trusted advisor to senior sales leaders. You may also help lead several cross-functional or organization-wide initiatives and HR projects. This role requires a combination of strategic thinking, operational excellence, and the ability to foster a high-performing and inclusive workplace culture.
The Medical Information Associate (Contractor) will be responsible for internal contact center responsibilities, including case intake, delivery of verbal and written responses to HCP and consumer requests for information on Shionogi products, and accurate documentation in Medical Information database. Additionally, this role will be responsible for capturing and reporting adverse events and product complaints in accordance with policies and procedures.
The Medical Affairs Operations Contractor ensures consistent and compliant field medical affairs operations. In accordance with Company Policies, the FMA Contractor will plan, execute, track, and report on Field Medical Projects including: FMA systems/tools, metrics, presentations, meeting planning, and overall operational coordination.
In partnership with the Medical Operational Excellence Lead & Field Team Leads, the Medical Affairs Operations Contractor will execute all field medical contracts, track respective invoicing, provide operational oversight on field initiatives and onboarding processes to ensure...
Shionogi Inc. (the “Company”) is seeking a Senior Paralegal/Contracts Manager to support its Legal Department. The primary responsibilities of the position will be to draft, review, negotiate and revise contracts on an independent basis. Additional responsibilities will include support activities for strategic transactions, support our contracts management system (Agiloft), and other projects, as needed. The SeniorParalegal/Contracts Manager would primarily support the VP, Corporate & Transactional Counsel and the Senior Pharmaceutical Counsel but would have accountability to the entire department.
In this newly created role, as the Senior Director of COA Strategy, Development & Implementation, you will be responsible to ensure assets across the pipeline, including assets focused on rare disease, have incorporated COA measures that are fit for purpose and appropriate for label inclusion. The position will also focus on integration of digit health technologies into clinical protocols to further inform impact of treatment effect on patient outcomes.
This role will serve as the technology business partner to Field Operations, Marketing, and Medical Affairs providing hands-on, technical and functional collaboration to support and improve the functioning and capabilities of Shionogi’s Veeva Commercial platform, commercial reporting and commercial data warehouse. This position reports to Associate Director, IT Commercial Systems.
The Senior Manager/Associate Director, Sales Training will play a pivotal role in onboarding a new primary care sales force and preparing them for the launch of Ensitrelvir, a novel 3CL protease inhibitor for the prevention of SARS-CoV-2 infection and investigational oral antiviral agent being evaluated in patients with mild to moderate COVID-19 infection.
The Senior Manager/Associate Director, Sales Training will assist with the design, development, and execution of comprehensive pre-launch and launch training programs to equip the new sales force with the knowledge, skills, and confidence necessary to excel in a high-impact fast-evolving market.
We are seeking a strategic and results-driven Head of Primary Care Sales to lead the build of a new primary care sales team and launch of a new COVID therapy. The ideal candidate will have a proven track record of driving sales growth, building high-performance teams, and fostering key relationships within the primary care market, including urgent care. The Head of Primary Care Sales will play a crucial role in achieving revenue targets, expanding market share, and contributing to the overall success of the organization.
This is a field position, with significant presence expected in home office...
Reporting to the VP of Marketing, the Brand Lead will be responsible for developing and implementing all elements of the US Brand Strategy for a novel 3CL protease inhibitor for the prevention of SARS-CoV-2 infection. Working with both internal and external partners, as needed, the Brand Lead will be responsible for the cross-functional launch planning and execution and will be ultimately responsible for the overall success of the launch.The ideal candidate will have the ability to create a superior end-to-end customer experience with a mindset for growth and a “play to win” attitude. The candidate should possess...
Reporting to the VP of Marketing, the Brand Lead will be responsible for developing and implementing all elements of the US Brand Strategy for a novel hospital antibiotic for the treatment of highly resistant Gram-negative infections. Working with both internal and external partners, as needed, the Brand Lead will be responsible for cross-functional strategic planning and tactical execution and will be ultimately responsible for the overall success of the Brand.
The ideal candidate will have the ability to create a superior end-to-end customer experience with a mindset for growth and a “play to win” attitude. The candidate should possess strong leadership...
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,...
We are seeking an experienced Sr. 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 collaborate with clinical study teams and internal departments to assess and mitigate risks associated with vendors.
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 Director, HCP Promotion Lead will be responsible for the development of personal and non-personal HCP promotional strategies and initiatives to support a new, first-in-class pharmaceutical product for COVID-19. While working cross-functionally and with internal and external partners, this role will be accountable for successful launch uptake with HCPs. The role will also be responsible for continued refinement of HCP strategy and messaging based on customer insights, analytics, and new clinical data. The ideal candidate will have an agile, innovative and growth mindset with the proven ability to analyze and create...
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...
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...
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 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 Global Executive Director, Development Real-World Evidence is part of the Clinical Development group and provides strategic oversight and direction for development 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...
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 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 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.
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 Promotional Medical Education Lead 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 to...
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 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.
