Shionogi Inc. (U.S.)

Technical Product Manager

• Manage the implementation and execution of the sourcing strategy for assigned commodities
• Ensure ongoing cross-functional coordination and deliver annual improvements in total cost
• Support the development and implementation of business systems for supplier partnerships
• Establish strong working relationships with other functions to support strategic sourcing perspective
• Track and manage core supply chain performance metrics

Supplier Manager, TPM

Director

• Engage with assets across the pipeline to identify patient-relevant concepts, guide asset team’s decision on COA measures that support clinical trials endpoints.
• Determine if COA measures are fit-for-purpose for label inclusion; guide the cross-functional team to assess COAs’ label worthiness based on FDA regulatory guidance (2018-2023 PFDD guidance documents).
• Conduct landscape assessments to better understand relevant patient concepts of interest and meaningful aspects of health for a given disease area.
• Determine whether to use publicly available COA measures as is, modify or develop de novo measures based on COA strategies that will inform necessary claims, support market differentiation, and access-related decision-making to improve patient and health system outcomes.
• Collect patient experience data including conduct embedded clinical trial interviews.
• Develop and oversee psychometric analysis plans to generate evidence that COA measures used in clinical trials are fit for purpose in the specific context of use.

Director/Senior Director, Clinical Outcomes Assessment Strategy, Development & Implementation

Medical Director

• Provide end-to-end global scientific leadership and medical strategy for assigned assets, including accountability for asset-level Medical Affairs budgets, tracking, and compliance in alignment with Global Medical strategy.
• Develop and maintain the global scientific narrative, scientific platform, and long-term positioning for assigned assets.
• Lead global scientific dissemination for assigned assets, including publications, congress strategy, and core scientific content modules, in alignment with publication governance.
• Provide medical leadership and scientific input into evidence generation activities, including Integrated Evidence Plans and lifecycle evidence planning, in partnership with Evidence Generation and Development teams.
• Provide medical leadership and input into clinical development programs, including early opportunity assessment, regulatory-facing activities, and lifecycle management for assigned assets.
• Lead external scientific engagement for assigned assets, including KOL strategy, advisory activities, investigator-initiated research, and partnerships with external experts and advocacy groups.
• Provide medical leadership across cross-functional teams to ensure global launch readiness and effective enablement of global and regional Medical Affairs teams.
• Contribute to building global Medical Affairs capabilities and ways of working, ensuring compliance with applicable regulatory, ethical, and quality standards.

Senior Medical Director, Global Medical Affairs – Virology

Compliance

• Support 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).
• 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 structure of compliant documents for electronic submissions.
• Coordinate with cross-functional teams, including Regulatory Affairs, Clinical Development, and Quality Assurance, to obtain the necessary information to ensure timely submission of regulatory documents.
• Conduct review of published submissions to ensure consistency and compliance with regulatory requirements.
• Perform quality control checks on documents to ensure accuracy and completeness, as well as resolve any issues that arise.
• Execute regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submissions.
• Maintain knowledge of local regulatory submission requirements.
• Ensure adherence to Company Standard Operating Procedures.
• Maintain compliance with current Good Manufacturing Practices (cGMPs), government regulations, industry standards, approved specifications, and Company procedures and directives.
• Supports in the review of Regulatory Operations processes (SOPs, work instructions, checklists, templates) for preparing submissions and regulatory information management.
• Other duties as assigned.

Regulatory Operations – Level 2 – Publisher

• Lead and advance strategic relationships with assigned specialty distributor and specialty pharmacy customers
• Collaborate with home office teams (e.g., Supply Chain, Finance, Forecasting, Market Access, Marketing, Sales Operations, and Legal) to address broad-based customer needs and channel challenges and ensure timely implementation of solutions
• Negotiate Trade account agreements that secure favorable market aligned terms, conditions, and fees while ensuring optimal patient, HCP, and pharmacy experience when sourcing medications
• Work directly with key customers, vendors, and internal stakeholders to identify new ways of addressing channel challenges and create win-win-win value, the account, and the patient and their provider
• Develop targeted channel solutions in the areas of: Order fulfillment and transportation models, Alternative distribution methods (e.g., direct distribution, drop-ship, other), Limited or exclusive Specialty Pharmacy arrangements

Associate Director – Trade Relation and Customer Management

Manager

• Apply broad pharmaceutical sciences and CMC expertise to develop and maintain commercial products
• Provide technical leadership for oral suspension and sterile injectable products
• Interact with external manufacturing partners and testing laboratories
• Participate in development and review of validation strategies for new products and processes
• Act as the Technical Lead and project manager on multidisciplinary development teams
• Collaborate with global teams to oversee drug development and manufacturing processes

Senior Manager, Pharmaceutical Sciences

Account Executive

• Promote and sell primary care products to healthcare providers
• Drive sales performance and meet territory expectations
• Develop and maintain relationships with healthcare professionals
• Educate healthcare providers on products and clinical evidence
• Implement targeting plans to enhance sales effectiveness

Associate Sales Representative – Primary Care

• Promote and sell primary care products to healthcare providers
• Drive sales performance and meet sales targets
• Build and maintain relationships with healthcare professionals
• Collaborate with internal teams to implement strategic business plans

Associate Sales Representative/Sales Representative – Primary Care

Sales

• Manage all aspects of new hire training, including but not limited to creating training curriculum, developing content, facilitating virtual and live classroom training, and coordinating logistics for each class
• Partner with the Training team, key stakeholders, and collaborative business partners to ensure training programs/content supports entire Training department and organizational goals
• Develop and execute sales training strategies that align with institutional sales goals and business objectives
• Design and develop training content including workshops, slide presentations, participant guides, and role play scenarios for POA and NSM meetings
• Coach and support new hires in developing role-specific skills through hands-on training and field rides
• Lead the facilitation of live, virtual, and blended training sessions for sales teams across the organization
• Manage the medical, legal, and regulatory review process for training materials and ensure all materials are approved prior to dissemination
• Manage and maintain ACTO, the commercial learning platform
• Model the way for all new hires, demonstrating Shionogi’s mission and values

Senior Manager – Institutional Sales Training

Operations

• Responsible for program and technical management of Shionogi products being developed in collaboration with U.S. Government agencies, ensuring alignment with program goals and timelines.
• Ensures full compliance with federal regulations and funding guidelines while effectively managing resources to advance the development of assets governed by U.S. government agreements.
• Serves as the primary liaison with U.S. government personnel, cultivating collaborative relationships to drive program technical execution and success.
• Monitors and compiles report on status to internal stakeholders, proactively identifying potential issues and proposing mitigation strategies to address potential risks.
• Leads program meetings and teleconferences with government agencies ensuring adherence to all reporting requirements and fostering clear communication.
• Manages development and review of program materials including presentations, meeting minutes, monthly reporting metrics, and cost allocations, ensuring accuracy and completeness.
• Supports initiatives to identify and evaluate new collaboration opportunities with U.S. Government agencies, coordination of White Papers, Technical Proposals, and Cost Proposals to secure future partnerships.
• Identifies and proactively manages risks associated with government contracts, including financial, regulatory, and operational risks.
• Monitors and tracks submission requirements to ensure timely compliance.
• Facilitates alignment and collaboration between internal teams (e.g., R&D, Finance, Regulatory Affairs, Legal) and external stakeholders to ensure seamless program execution.
• Contributes to the negotiation, execution, and amendments of contracts with government agencies.
• Represents Shionogi at industry forums, conferences, or government meetings to advocate for program needs and establish thought leadership.

Associate Director, Government Operations

• 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.
• 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.

Senior Regulatory Operations Publisher

• Effectively educate and engage healthcare professionals in dialogue about clinical evidence, approved indications, and product efficacy/safety profiles to support on-label prescribing for appropriate patients
• Function independently with sales proficiency to drive sales performance and ensure sales forecasts and assigned budgets meet or exceed therapeutic and territory expectations
• Build and develop professional relationships with (but not limited to) primary care healthcare professionals, pharmacy staff, within assigned customers and territory
• Develop and maintain in-depth knowledge of market, demographic, and managed care information relative to assigned territory
• Drive appropriate utilization of approved primary care product(s); the incumbent will work closely with cross-functional partners to generate pull-through within local payers, community HCPs, etc.
• Work with District Sales Manager and Regional Sales Director to develop a local strategy and business plan to generate high-performing sales in assigned territory
• Capitalize on formulary approvals and other opportunities through effective implementation of targeting plans by using a wide variety of promotional, digital, personnel resources and analytical tools to enhance effectiveness in assigned sales territory, based on local assessment of customer needs.
• Leverage expertise and knowledge of primary care marketplace, applicable competitors, industry and cross-functional activities/plans to anticipate and effectively manage business opportunities and challenges
• Provide special education to healthcare providers through appropriate programs that fall within Shionogi’s guidelines
• Provide relevant, thoughtful input to other commercial colleagues (e.g. sales leadership, regional account managers) in regard to strategic and tactical planning for territory, area, and region
• Prioritize time and effort to ensure optimal coverage of appropriate physician targets based on opportunity and potential through in-person and virtual discussions
• Understand fully the assigned customers’ product and business needs and works to meet those needs while adhering to all of Shionogi company ethics and compliance standards
• Anticipate potential barriers to achievement of goals and proposes responsible solutions for success
• Handle customer objections effectively and exceed customer expectations with the value they bring to physicians.
• Occasionally will be called on to share your exemplary skills with others in the region in a training capacity
• Leverage and embrace emerging technologies to enhance performance, while continuously striving to improve your proficiency
• Understand and comply with pharmaceutical industry guidelines and regulations and apply high ethical standard in day-to-day work

Sales Representative – Primary Care

Administrative Assistant

• Coordinate teleconferences, virtual meetings, on-site meetings, vendor and / or team meetings, and take meeting minutes as requested.
• Facilitate travel plans, both domestic and international, ensuring meticulous arrangements of accommodations, transportation, and troubleshooting, for team members including, publishing, and calendaring all itineraries and plans.
• Provide a high level of support to office visitors, ensuring a seamless and positive experience.
• Manage expense report preparation and reconciliation according to the company’s policy.
• Conduct normal course of business while maintaining confidentiality of sensitive information.
• Communicate any company messages, alerts, new policies, practices as disseminated by company leadership.
• Prepare, route, and oversee review and approval for all contracts, invoices, and POs required by the department utilizing Strat-Pi and other SI-based systems | interfaces.
• Ensure all pertinent project-related content is included in KMNet & Strat-Pi supporting GSO team members at SI.
• Complete desk research on requested topics as needed.
• Assist with on-boarding new employees and contractors as requested.
• Copying, faxing, filing, mailing overnight/shipping as required.
• Coordinate the ordering of supplies, materials, publications, services, etc.
• Perform other administrative or office duties or projects as required or as assigned.

Senior Administrative Assistant, Global Scientific Operations

QA Engineer

• Lead Quality Assurance efforts for pharmaceutical products manufactured by third-party manufacturers
• Develop and Implement Quality Assurance strategies, policies, and procedures specific to third-party manufacturing
• Conduct rigorous assessments and audits of potential and existing third-party manufacturers
• Oversee and provide guidance on the design and execution of validation
• Provide technical guidance and support to third-party manufacturers regarding quality systems
• Collaborate with Regulatory Affairs teams to support product registrations
• Resolve quality issues and initiate investigations
• Perform batch record review and communicate adverse findings
• Manage the development of product specifications and sterility assurance practices
• Review and approve stability protocols and results

QA Product Manager

Communications

• Develop and execute U.S. communication strategy and plans that convey scientific and medical education and information
• Identify key target audiences and define key messages
• Lead the planning, creation, and execution of the overall U.S. Medical omnichannel strategy
• Manage the budget for all U.S. Scientific Communication activities
• Engage key opinion leaders and external stakeholders to gather medical insights and develop educational materials.