Shionogi Inc. (U.S.)

Manager

• Hire, coach, develop and retain a high-performing team of primary care sales representatives
• Deliver sales performance to meet or exceed district sales plan
• Oversee daily in-field activity and management of sales team
• Ensure team execution of territory account plans
• Optimize resource utilization by setting sales performance targets

District Manager – Primary Care

Attorney

• Primary responsibility for managing Shionogi Inc.’s contract management system (Agiloft Contract Management Software) and training stakeholders on the system requirements and process for submission, review and execution of agreements.
• Provide initial review and (where appropriate) provide feedback to business clients in multiple departments on Master Services Agreements, Task Orders/Statements of Work, Change Orders/Amendments, Consulting Agreements, CDAs, and other agreements on a timely basis.
• Work closely with legal, finance, IT, and business teams, and vendors to expedite the review and execution of agreements; monitor contract workflow in Agiloft and shepherd contract drafts between reviewers.
• Exercise independent judgment regarding appropriate type of agreement and information required for preparation.
• Responsible for system maintenance, monitoring regular updates, investigating and recommending modifications to users, developing requirements for and testing of custom features, and working directly with system vendors on implementation.
• Maintain user access and permissions.
• Review and suggest changes to legal agreement templates and ensure most recent versions of templates are available in contracts management system; respond to questions from the business regarding templates and submission of contracts for review.
• Provide administrative support to legal team members including meeting/training set-up, travel arrangements, submission of expense reports, communication with outside counsel for monthly legal expense accruals, processing of purchase orders and invoices, managing department subscriptions, onboarding of new team members, etc.
• Establish and foster effective working relationships with business clients, maintaining an up-to-date understanding of the business to provide effective advice and direction.
• Assist with legal and compliance training initiatives and materials.
• Assist with corporate administration and ongoing compliance for legal entities.
• Coordinate approval of Board minutes and ensure Board meeting folders are up to date.
• Other duties as assigned.

Senior Legal Operations Specialist

Account Executive

• Promote and sell primary care product(s) to healthcare providers
• Drive sales performance in alignment with business goals
• Develop and implement a strategic business plan for Primary Care Physicians
• Build and develop professional relationships with primary care healthcare professionals
• Work closely with cross-functional partners to generate pull-through within local payers
• Provide special education to healthcare providers through appropriate programs

Associate Sales Representative – Primary Care

Recruitment

• Work in partnership with HRBP from role approval through offer to develop and execute targeted recruiting strategies that support business goals.
• Facilitate effective sourcing strategies to attract top talent and develop a strong, qualified candidate pool for current and future openings.
• Proactively pipeline and pre-screen diverse slates of candidates (passive and non-passive), partnering with team members to manage sourcing strategies and supplying talent for open positions.
• Provides positive and clear communication with hiring managers throughout the recruitment process; aligning on sourcing strategy, interview approach, and decision-making while establishing clear roles, expectations, and mutually agreed-upon timelines.
• Manage ATS requisitions compliantly, ensuring accurate data tracking and reporting, in accordance with TA processes.
• Compile and communicate the knowledge base, industry insights and market trends to team members and business leaders.
• Oversee the interview debrief process.
• Be a trusted advisor that supplies direct feedback to the hiring team and influences hiring decisions.
• Partner with the compensation and HRBP team, recommend offer packages and negotiate employment offers.
• Partner with broader HR team to integrate company values and competencies into the recruiting process.
• Provides backup coverage for the Senior Director of Talent Acquisition, supporting daily departmental initiatives, reporting and projects as required.

Senior Talent Acquisition Manager

• Promote and sell primary care products to healthcare providers
• Drive sales performance by developing a strategic business plan
• Educate healthcare professionals on product efficacy and safety
• Develop and maintain relationships with primary care professionals
• Collaborate with internal partners to drive sales results

Associate Sales Representative, Primary Care

• The Manager, IT Web Services will be primarily responsible for the design, development, and support of our company’s external web properties.
• Works independently on requirements gathering, technical support, delivery, operations and engineering.
• Installs, configures, updates, deploys, integrates and operates websites and applications.
• Ensure web solutions adhere to industry best practices for security, accessibility, SEO, and performance
• Participates in solution design reviews of digital solutions (e.g. web applications) and provides subject matter expertise.
• Manage vendor and agency relationships for specialized design, content, and quality assurance.
• Takes ownership of tasks and projects, assuming full responsibility for their timely completion.
• Provides architecture and technical leadership across a range of digital and middleware technologies.

Manager, IT Web Services

Compliance

• Lead in the preparation and submittal of regulatory applications and on ‐ going application maintenance in accordance with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (eg, IND, NDA/BLA, MAA, CTA DMF).
• Participate in project-planning meetings to provide input on submission timelines in collaboration with Manager, Regulatory Operations.
• Ensure consistency across regulatory submission documents following the regulatory style guide (i.e. formatting, reviewing, and submissions).
• Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents.
• Conduct final review of published submissions to ensure consistency and compliance with regulatory requirements, as well as ensure metadata is correctly applied.
• Execute regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submissions.
• Maintain compliance with current Good Manufacturing Practices (cGMPs), government regulations, industry standards, approved specifications, and Company procedures and directives while continuing to stay well-informed on future developments.
• Actively participate in the development of Regulatory Operations processes (SOPs/GOPs, work instructions, checklist, templates) for preparing submissions and regulatory information management, in addition to assisting in the creation and maintenance of templates.
• Work with Veeva RIM BA(s), subject matter experts, and cross functional departments to analyze and develop processes that support business needs using the Veeva Vault RIM suite (Submissions and Submissions Archive)
• Develop global partnerships across the organization to help implement Regulatory Operations’ initiatives by attending and participating in Project Teams if deemed appropriate by manager.
• Maintain knowledge of local and global regulatory submission requirements.
• Assist in supporting Regulatory Operations’ technology including, but not limited to publishing tools, databases, and servers.
• Ensure adherence to Company Standard Operating Procedures.
• Mentor and support junior-level team members as needed to help facilitate the team’s growth.
• Perform managerial activities in manager’s absence.
• Other duties as assigned.

Senior Publisher – Regulatory Operations

• Assist in the conversion of tables, figures and listings from txt to pdf
• Assist in the downloading and QC of information from one location to another
• Assist in the preliminary QC of pdf bookmarks and hyperlinks
• Assist in the preliminary creation of pdf bookmarks in documents to ensure submission readiness
• Assist in the compilation of pdf documents to create a single submission ready document
• Assist in verifying documents in a published outline
• Assist in verifying metadata on a published sequence
• Assist in archiving submission sequences and correspondences in Veeva RIM
• Provide support to the Regulatory Operations team

Regulatory Operations Contractor

• Serve as the Regulatory Affairs lead for assigned clinical programs and submissions, acting as the primary point of contact for regulatory activities.
• Lead preparation, organization, and QC review of regulatory submissions (e.g., INDs, NDAs, amendments, supplements).
• Manage submissions end-to-end, from planning through publishing and final delivery in partnership with Regulatory Operations.
• Own and drive regulatory deliverables, ensuring alignment with timelines, quality standards, and regulatory requirements.
• Contribute to the development and execution of regulatory strategies for assigned programs, applying regulatory knowledge and critical thinking.
• Interpret regulatory requirements and assess their impact on study design, submissions, and documentation.
• Identify regulatory risks, support development of mitigation strategies, and drive issue resolution or escalation as needed.
• Lead and/or facilitate cross-functional alignment and provide regulatory guidance to ensure consistency, accuracy, and compliance across deliverables.
• Represent Regulatory Affairs on cross-functional teams, clearly communicating regulatory considerations, timelines, and risks to stakeholders.

Manager, Regulatory Affairs – GDP

• Responsible for committee review activities in support of external commercial and corporate communications
• Provide committee review requirements to corporate and commercial functional project managers and external vendors
• Leads a cross-functional PMRC that assesses risks of promotional materials
• Provide governance and scheduling of committee activities for developing promotional draft labeling
• Manage the overall PMRC process as outlined in the PMRC SOP
• Effectively interact with external agencies about marketing materials
• Schedule PMRC meetings and lead discussions
• Conduct functional reviews and approve for submission to FDA OPDP as required
• Work closely with Regulatory Affairs department to ensure timely submission of materials
• Track all electronically submitted promotional pieces submitted by the Regulatory Operations to OPDP above

Promotional Materials Review Committee Manager

QA Engineer

• Lead and coordinate end-to-end technology transfer projects for drug substance and/or drug product
• Oversee and provide guidance on the execution of validation activities related to sterile manufacturing processes
• Lead the Quality Assurance activities for sterile pharmaceutical products manufactured by third-party manufacturers
• Review batch records and perform final disposition
• Conduct rigorous assessments and audits of potential and existing third-party manufacturers
• Collaborate with Regulatory Affairs teams to support product registrations, submissions, and regulatory inspections

QA Product Manager – Sterile Products

General Counsel

• Provide experienced, hands-on legal support focused on drafting, reviewing, negotiating, and advising on agreements
• Manage M&A and pharmaceutical licensing transactions
• Negotiate sophisticated agreements independently with external parties
• Perform due diligence and interpret existing agreements independently
• Draft, review, and negotiate a wide range of agreements
• Advise on contractual risks, mitigation strategies, and compliance
• Collaborate with cross-functional stakeholders to provide clear legal guidance
• Support efficient contract intake and management within the CLM system

Senior Counsel – Contracts and Transactions

Director

• Develop and maintain agile analytical framework that converts raw commercial data into repeatable, scalable insights defining brand strategy
• Conduct hands-on, deep-dive analysis across sales, prescriber, access, and patient-level data, incorporating advanced predictive modeling to uncover growth drivers, risks, and opportunities
• Lead performance diagnostics through variance and root-cause analysis, connecting actual results to forecast assumptions and delivering synthesized, insight-driven narratives to inform commercial decision-making
• Own national and sub-national brand performance reporting and analytics, developing and maintaining dashboards and KPI frameworks to track launch performance and enable rapid decision making
• Spearhead design and execution of periodic Business Reviews integrating insights across analytics, market research, sales, marketing, and market access to develop a single source of truth for brand performance narrative
• Design and execute HCP and account-level segmentation and targeting strategies to drive field team effectiveness across Primary Care and Long-Term Care teams
• Collaborate with Sales Leadership to translate analytics into actionable field strategies and measurable performance improvements
• Partner with Marketing to design and optimize omnichannel analytics strategy, including measurement, attribution, and optimization of digital marketing performance across channels
• Design and execute A/B testing to assess the effectiveness of promotional tactics and pilot programs
• Lead marketing mix and promotional response modeling to quantify channel ROI and inform forward-looking investment optimization
• Support Market Access strategy by providing data-driven insights on contracting, coverage, and patient affordability dynamics
• Quantify the impact of access dynamics (formulary status, restrictions, payer mix) on brand performance and patient flow
• Support brand-level forecasting processes - sourcing and validating assumptions for epidemiology, time series analysis, primary market research, patient dynamics, access environment, promotional drivers, and competitive landscape
• Closely partner with Commercial Operations functions, including Commercial Data Management, Field Operations, and Market Research, to integrate data, capabilities, and insights into a cohesive analytical ecosystem for the brand
• Drive adoption of modern analytics and AI tools (e.g., LLMs, automated insight generation, advanced modeling) to improve speed, scalability, and impact of analytics
• Serve as a strategic thought partner to Marketing, Sales, Market Access, and Sales Operations, shaping commercial strategy through deep analytical insight and proactive, hands-on engagement

Director, Insights & Analytics – COVID

• Manage the implementation and execution of the sourcing strategy for assigned commodities and/or products
• Ensure product supply and ongoing cross-functional coordination
• Deliver annual improvements in total cost, quality, and service
• Support development of strong business systems to manage supplier partnerships
• Monitor and uphold contractual requirements related to managed products
• Champion annual productivity improvements and pursue continuous quality improvement and cost reduction opportunities

Supplier Manager, Third Party Manufacturing

Marketing

• Develop the Commercial brand plans with direction from key project owners
• Track implementation and share insights with stakeholders
• Leverage insights from various sources to develop brand strategy
• Own Data on File documentation for promotional messages
• Collaborate with Marketing colleagues, field leadership, and external partners
• Lead special marketing projects through development stages
• Develop key analyses and presentations for senior commercial leadership
• Ensure agency contracts are executed per compliance standards
• Analyze and present on key market trends