Job Listings

Sr. Manager, Computerized Systems Validation & QA (Florham Park, NJ) – Analyze and perform quality assurance and validation functions in computerized systems in support of pharmaceutical manufacturing GxP guidelines, QMS (Quality Management Systems),  and equipment in accordance with FDA/EMA/PMDA/ICH regulations, 21 CFR part 11; Develop and implement validation programs and qualification tools to improve process monitoring and optimization using Data Integrity controls; Review Change Control requests and assess impact to validation using SNOW Change Management process compliance; Perform internal quality control and Site Audit Planning using Supplier Audit Risk Assessment...

The Area Business Lead for LTC is a first-line field sales leadership role accountable for building and leading a high-performing team of LTC Account Managers across a multi-state territory 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 long-term care sales teamand will be directly responsible for field...

The Area Business Lead for LTC is a first-line field sales leadership role accountable for building and leading a high-performing team of LTC Account Managers across a multi-state territory 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 long-term care sales teamand will be directly responsible for field...

The National Director for LTC is responsible for designing and executing a comprehensive U.S. strategy that drives product access, demand, adoption, and sustained utilization across the long-term care continuum. This role oversees area leadership teams, directs pull-through within institutional accounts, and ensures consistent execution across LTC pharmacies, SNFs, ALFs and other key accounts.

The Director/Sr Director of Psychometrics within Clinical Development, will be responsible to ensure that Clinical Outcomes Assessments –rated by clinician, caregiver or participants-- included in drug development clinical trials as primary or key secondary endpoints have the necessary psychometric properties to support regulatory submissions. This position works closely with Shionogi’s Clinical Outcome Assessment Center of Excellence and other cross-functional colleagues to help inform all clinical trial endpoints based on quantitative measurement properties of an assessment within a given context of use.

Reporting to the Executive Director, US Pricing Strategy & Government Impact, the Director, US Pricing Strategy is responsible for developing comprehensive pricing strategies to support Shionogi, Inc. in-line and pipeline product portfolio as well as providing support for business develop opportunities as needed.  This role will provide pricing subject matter expertise and be responsible for a breadth of strategy and operational pricing activities, including developing and implementing product launch price recommendations, contracting strategies, providing pricing and access assumptions to support business development projects as well as staying abreast of government led policy proposals and...

The Associate Director of USRA Advertising & Promotion will be responsible for providing strategic guidance and leadership relating to promotional activities. The Associate 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 Associate...

The Senior Manager, Promotional Review Process Lead 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, stakeholder training, and managing other promotional review process associates. Reporting to the Senior Director, USRA Advertising and Promotion, the Manager/Senior Manager will be a critical member of the USRC and strategic partner for the...

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. 

Reporting to the Senior Director, Consumer Marketing, the Senior Manager, Consumer Marketing is responsible for developing and executing consumer marketing strategies for an upcoming launch brand. This role will focus heavily on digital innovation and omnichannel engagement to drive awareness and education. The ideal candidate will bring a strong digital-first mindset, deep understanding of patient journeys, and experience navigating the regulatory landscape of pharmaceutical marketing.

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 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...

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.

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 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.

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...

Support the Regulatory Affairs (Executive Director) in developing and executing regulatory strategies for antiviral programs globally or within specific regions

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 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, 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...