Shionogi Inc. (U.S.)

Medical Director

• Develop and oversee the execution of Medical Affairs programs in the US
• Collaborate with VP Medical Affairs and Executive Medical Director to propose strategic medical affairs plans
• Assist in creating Medical and Scientific programs
• Develop and manage relationships of US Key Opinion Leaders (KOLs)
• Represent Medical Affairs on promotional and non-promotional medical-legal-regulatory review committees
• Maintain scientific expertise in areas such as ALS
• Lead the Medical Plan development in collaboration with other medical cross-functional partners

Medical Director, Medical Affairs – Rare Disease

Associate

• Provide operational and coordination support to the U.S. Review Committee (USRC) process for assigned products.
• Assist with preparing promotional materials for review, facilitating meetings, maintaining documentation in Veeva PromoMats, and ensuring efficient workflow execution under the direction of USRC leadership.
• Act as the primary point of contact for the promotional review process and liaise between Commercial Leads, Reviewers, and Agencies for assigned products.
• Ensure materials are ready for review, editing and quality checking materials.
• Facilitate high-quality USRC meetings, supporting planning activities, and providing training on USRC processes and Veeva PromoMats.
• Track promotional materials from inception through approval and provide actionable feedback where there are workflow issues.
• Monitor document lifecycle including reapprovals and expiry of materials in accordance with USRC SOP.
• Perform comment verification on documents to ensure USRC advice has been incorporated correctly; follow-up with individual USRC Reviewers when further clarification is needed.
• Proofread materials for accuracy, grammar, misspellings, punctuation, formatting, and stylistic errors.
• Check materials for alignment to Brand style guide, USRC guidelines, and corporate policies.
• Provide training on USRC process and Veeva Promomats as needed.
• Coordinate logistics for USRC escalation meetings as needed.

Senior Promotional Review Associate – Contractor

Medical Science Liaison

• Establishes, manages, and maintains successful relationships with relevant healthcare entities
• Designs and executes plans for the assigned MSL region with alignment to medical strategy
• Responds to and documents unsolicited medical and scientific requests for information
• Delivers fair-balanced clinical and scientific presentations
• Attends national and regional medical/scientific meetings and engages in discussions

Senior Medical Science Liaison – COVID, Virology

Director

• Lead epidemiology and RWE strategy for assigned therapeutic areas, with a strong focus on the U.S., in alignment with broader functional priorities
• Provide expertise in epidemiologic methods, observational study design, causal inference, and database strategy
• Support implementation of global RWE strategy in the U.S. and collaborate with regional colleagues to promote alignment across geographies
• Manage RWE budgets and oversee vendor partnerships, database utilisation, and external research collaborations within assigned areas
• Provide epidemiology and RWE input to cross-functional decisions related to study design, evidence planning, regulatory submissions, and payer materials
• Represent the function in selected external engagements with academic partners, vendors, and scientific forums, as appropriate
• Contribute to methodological innovation and continuous improvement in epidemiology and RWE practices
• Manage or mentor scientific staff and consultants, and support development across the epidemiology function
• Support functional capabilities by contributing to processes, SOPs, systems, and best practices

Director, Global Epidemiology – Real-World Evidence

• Partner with Head of US Rare Disease for strategy and launch planning.
• Leads the development of launch strategy and brand plans.
• Manage information flow and executive communications.
• Develops key analyses and presentations for senior leadership.
• Own budget from development through execution.
• Works cross-functionally with various internal and external teams.

Senior Director, Portfolio Strategy and Execution – Rare Disease

Clinical Operations

• Update and maintain clinical systems within project timelines and review files for accuracy and completeness
• Support the Clinical Operations team with ongoing conduct of studies including specific allocated study management tasks as defined by the Clinical Trial Manager (CTM)
• Support inspection readiness
• Prepare, handle and distribute of Clinical Trial materials and maintenance of tracking information
• Act as a central contact for the clinical team for designated project communications
• Schedule Project related meetings, attend operational team meetings, write and/or review meeting minutes, distribute minutes and follow-up actions
• Assist with preparation of meeting materials, presentations
• Prepare, handle, distribute, file and archive clinical documentation and reports according to standard operating procedures
• Assist with identification of potential clinical sites; maintain investigator lists
• Support organization of investigator meetings/advisory boards
• Review of study files periodically for accuracy and completeness
• Track and manage Case Report Forms (CRFs), queries and clinical data flow
• Utilize JDE system to monitor funds on existing purchase
• Manage tracking of all Clinical operations contracts generated (i.e. coding, approvals, filing, etc.) and associated invoices
• Other duties as assigned

Contract - Clinical Trial Associate, Clinical Operations

• Provide hands-on expertise and works collaboratively to design and execute all commercial analytical deliverables related to the launch of XOCOVA
• Support the Senior Director of I&A in the build, analysis, and communication of accurate short-term and long-range demand and revenue forecasts
• Develop deep understanding of brand disease state(s) and contribute to competitive intelligence efforts
• Deliver data driven insights through the development of presentations and dashboards
• Develop and lead the launch tracking review process for the field teams
• Proactively partner with Commercial Data Management and Field and Marketing Operations to automate standardized reports

Associate Director, Insights & Analytics

Compliance

• Support document formatting and QC in alignment with Shionogi standards for submission-related materials.
• Assist in the remediation and QC of PDF documents, including bookmarking and hyperlinking to ensure regulatory-compliant electronic files.
• Assist in ensuring all communications with health authorities are properly archived within the company’s system and adhere to applicable regulatory guidelines.
• Assist the archiving and retrieval of documents from offsite storage facilities.
• Provide ongoing support to the Regulatory Operations team.

Regulatory Operations Documentation Specialist

QA Engineer

• Provide quality oversight and GCP guidance to clinical study teams and CROs/vendors
• Ensure clinical trials adhere to GCP principles, producing high-quality and reliable data
• Evaluate clinical trial documentation, processes, and study plans to ensure alignment with Shionogi’s expectations and regulatory requirements
• Collaborate with clinical study teams to provide vendor quality oversight, identify risks, and propose remediation actions
• Conduct CRO or vendor audits or assessments
• Support GCP regulatory inspections and manage assigned CAPAs identified during inspections

Senior Manager, GCP QA

Administrative Assistant

• Provide administrative support to Commercial Teams in all day-to-day processes
• Manage executive and their team members calendars and schedule appointments/meetings
• Responsible for coordinating meetings across multiple calendars
• Process expense reports for team members according to billing statements in timely manner
• Coordinate and assist with corporate and department initiatives development and execution
• Coordinate extensive travel planning and itineraries for team members
• Manage Contract Process and navigate internal and external clients
• Manage payment process by creating purchase orders and processing invoices for payment
• Greet and interact with incoming guests with professional manner
• Maintain and order office supplies as needed

Senior Administrative Assistant - Commercial

Account Executive

• Promote and sell primary care products to healthcare providers
• Drive sales performance and align with business goals
• Develop and maintain relationships with healthcare professionals
• Collaborate with internal partners to drive sales results

Associate Sales Representative – Primary Care

• Promote and sell primary care products to healthcare providers
• Drive sales performance within the assigned territory
• Build professional relationships with primary care healthcare professionals
• Collaborate with Marketing and internal partners to drive sales results

Associate Sales Representative, Primary Care

Business Development Rep

• Provide experienced, hands-on legal support focused on drafting, reviewing, negotiating, and advising on complex agreements
• Collaborate closely with Global Legal and Compliance teams
• Negotiate highly individualized and sophisticated agreements independently with external parties
• Direct and oversee the work of outside counsel
• Draft, review, and negotiate a wide range of agreements
• Serve as a trusted legal advisor to cross-functional stakeholders

Senior Counsel – Contracts and Business Development Transactions

Chief of Staff

• Own the end-to-end planning, preparation, and follow-up for all key governance forums
• Develop structured agendas in partnership with the CEO, ensuring alignment on priorities and decision frameworks
• Drive rigorous follow-up on action items, decisions, and commitments arising from governance meetings
• Coordinate and manage monthly reporting cycles to Japan headquarters
• Act as a key liaison between the US affiliate and Japan HQ, facilitating clear communication and aligned expectations
• Support the CEO in translating strategic priorities into actionable plans with clear milestones
• Track progress against corporate, strategic and operational objectives; surface risks and opportunities proactively
• Architect and maintain a digital platform to centralize governance materials and project tracking
• Partner closely with various functions to synthesize inputs and coordinate integrated planning
• Prepare high-quality executive communications for internal and external audiences

• Provide medical/scientific support for relevant Shionogi products as a medical subject matter expert.
• Lead the US Medical strategy and tactical planning for COVID-19/Viral Diseases platform.
• Lead and develop a high-performing Medical Affairs team, ensuring clear priorities and strong execution.
• Oversee and provide medical sign-off on all relevant product and disease state communications.
• Serve as the voice of the therapeutic area in various commercial projects and initiatives.
• Shape the development of Company documents ensuring scientific accuracy.
• Collaborate effectively with drug safety team members to optimize pharmacovigilance activities.
• Oversee Scientific Communication with support from Scientific Communications leads.
• Drive communication and collaboration of Medical plans with SHQ and SBV.
• Lead key opinion leader (KOL) planning including selection of outside experts and maintain relationships.