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We are a company that believes in performance excellence, which is based on a framework of Performance, Leadership, and Continuous Improvement. We will accelerate our sales growth through the leadership and development of our people to outperform the competition. Position Summary:The Renal Account Manager contributes to OAPI’s overall sales objective by performing assigned sales related activities. Provides hospitals, physicians, pharmacists and healthcare providers with products, services, and information that will enable them to use and prescribe OAPI products safely and effectively.We are looking for individuals who are highly motivated, learning agile, and can grow in a Commercial organization.Otsuka-people who:- Think differently by challenging conventional thinking- Are intellectually curious and life-long learners- Are effective, ’get it done’ and have a sense of ownership- Are comfortable with ambiguity, autonomy and recognize that innovation is at its best when people connect- Are remarkable in their chosen fieldKey Job Expectations/Responsibilities:- Ensures full compliance with drug laws, regulations, and OAPI policies in all aspects of interactions with healthcare professionals- Achieves the assigned sales objective for the territoryEffectively manages the formulary process to ensure product acceptance to assigned hospital accounts by establishing credibility with key hospital stakeholders, performing timely formulary review for products, expediting formulary acceptance of product, implementing effective plans for product pull-through, and organizing in-services to communicate appropriate approved product information to appropriate hospital personnel on all shifts- Attains the designated goals for calls on appropriate accounts and healthcare professionals- Communicates balanced, accurate, and complete information on OAPI products- Executes calls on pharmacists in order to provide product information and to ensure the availability of OAPI products in assigned accounts within the territory- Collaborates with market access team for formularies and product availability- Demonstrates consistent completion of all administrative requirements in a timely manner, including call reporting, budget management, log-ins, etc.- Completes all required training courses and continually updates product knowledge- Assists district manager in training new Renal l account managersCompliance Management:- Ensures full and complete compliance of all selling activities within the area of responsibility to OAPI standards and to all state and federal regulations- Complies with the letter and spirit of all state and federal laws, regulations, and guidance as well as PhRMA Code on Interactions with Healthcare Professionals and OAPI standards and policies relating to all promotional activities
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The Account Manager is considered to be skilled or advanced in their demonstration of account management capabilities and sales proficiencies. This individual contributor is self-sufficient and able to apply skills successfully in all situations. Specifically the Account Manager will demonstrate ability in the following areas: Local Market Expertise - Ability to collaborate with internal and external partners to gather and validate key trends and dynamics in the market, map account linkages including stakeholders that exhibit direct and indirect influence on customer behavior. Utilize market knowledge to uncover and prioritize unique opportunities that will allow for mutual value between Otsuka and our customers Reimbursement - Consistently demonstrates the ability to stay informed on reimbursement dynamics, anticipate and communicate impact on product portfolio to key internal and external partners and problem solve payer access issues (Medicare, Medicaid, Commercial) through the use of Otsuka resources Business Planning and Execution - Ability to prioritize opportunities, develop strategy & tactics,, allocate resources, monitor progress and adjust direction in an effort to maximize sales performance and measure progress against plan Critical Thinking - Ability to understand a situation, issue, or problem by breaking it into smaller components. Ability to collect information, derive inferences, find solutions and make informed decisions and recommendations using data and tools where appropriate Pharmaceutical Environment - Ability to apply knowledge of pharmaceutical and regulatory environment, including Otsuka policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply knowledge of overall healthcare economy and industry practices Therapeutic Area Knowledge - Ability to apply therapeutic area knowledge to the sale of Otsuka’s products and/or to increase effectiveness in role Customer Development - Build and maintain productive internal and external relationships (e.g. customers, account contacts, stakeholders and influencers e, etc) based on customer needs and organizational goals Selling - Understand the core selling process, adapt style, and effectively negotiate to bring value to the customer and close the sale Key Job Responsibilities: Drive for Results -Can be counted on to exceed goals successfully, is constantly and consistently able to develop top performing teams, very bottom-line oriented, steadfastly pushes self and others for results. Peer Relationships - Can quickly find common ground and solve problems for the good of all, can represent his/her own interests and yet be fair to others, can solve problems with peers, direct reports and matrix team members with a minimum of noise, is seen as a team player and is cooperative, easily gains trust and support of colleagues, encourages collaboration. Critical Thinking Establish standards for collecting and organizing data to assess business trends, opportunities Summarizes complex situations or data sets into easily understood information Makes critical decisions using information gathered and develops others in their ability to organize their thoughts, identify patterns in data, and facilitate decisions making Leads broad problem solving efforts and guides others in identifying and analyzing problems and determining solutions Business Plan Development and Execution In collaboration with key internal and external partners can effectively (consistently and accurately) lead all components of a business plan (milestones, tactics, budgets, resources)Continually analyzes performance against plan and is proactive in planning sales activities to maximize customer calls and impactAble to write an integrated plan, which can be used during execution of multiple projects Manages multiple constituents at various levels of the organization to drive towards meeting timelines and milestones Evaluates the results of timelines and resource plans and recommends changes Evaluates regional performance vs. external benchmarks and works with Regional Directors to coordinate internal resources to improve performance benchmarks External Partnerships Coordinate with alliance partner sales management team within region geography Customer Management Manage key account coordination along with the District Managers to develop relationships leading to increased profitability and better patient outcomes Compliance Management Ensure full and complete compliance of all selling activities within the area of responsibility to OAPI standards and to all state and federal regulations Comply with the letter and spirit of all State and Federal laws, regulations, and guidance as well as PhRMA Code on Interactions with Healthcare Professionals and OAPI standards and policies relating to all promotional activities Identify risks and issues associated with non-compliance and implications of regulatory infractions Qualifications
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The Associate Director – Global R&D Clinical IT Business Information will partner with the business functions to anticipate, capture, and build business cases for the adoption of R&D systems for EDC, CTMS, Clinical Studies’ Data, Pharmacovigilance, Wearable, Digital, Cloud, and software development to enhance Otsuka’s R&D capabilities. - Leverage the platform, infrastructure, project management, application support, and corporate security functions within OIT to assess and select COTS and or software development team teams to enable R&D capabilities. - Work with stakeholders at all levels of the organization in a global, matrixed, multi-cultural, collaborative environment to evaluate cost-benefit analyses and the total cost of ownership for enabling capabilities. - Drive business and technical requirements analysis, business process modeling/mapping, methodology development, and data modeling efforts to support Otsuka’s clinical trials.
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The Associate Director, Sales Automation position requires a commercial operations leader who possesses strong business acumen, has a solid understanding pharmaceutical sales, marketing and managed markets business processes, pharmaceutical data sources, field force support, field force reporting, as well as a working knowledge of commercial technology enablers and practices.As business owners of Customer Relationship Management (CRM) solutions including Field Force Automation (FFA), Business Reporting & Analytics (BI), Data Management (DW-MDM), Closed Loop Marketing (CLM), Workflow Automation (WFA), Call Center & Customer Service (CC) and other commercial applications, the Associate Director, Sales Analytics & Automation is responsible for providing enabling technologies for all in-line brands and launch planning support for future brands. Additionally, this position is the main POC between, Commercial IT, BAI and other commercial operations team ensuring strategic and tactical support for the sales organization.As a member of the Sales Operations team, the Associate Director, Sales Automation leads the resolution efforts for field teams technical and business issues associated with their CRM tools or services. This includes but is not limited to field inquiry management, help desk escalations and triage, solutions related communications, training and change management. This role also serves as a key stakeholder in data governance efforts and is responsible for maintaining the integrity, compliance and quality of sales automation systems and data.This position will be a strategic partner with Field Training and Development to design and conduct new hire training and other on-going and advanced training on sales force automation and enablement technologies. This position will also be responsible for leading Customer 360 efforts as they pertain to enablement of C360 insights to field forces. This position will work collaboratively with a cross functional Customer 360 team to drive and enable this critical organizational initiative.The Associate Director, Sales Automation and Technologies position requires the ability to interact and influence cross-functionally with a variety of internal departments, co-promotion partners and outside vendors. The position has direct vendor and budget management responsibility. This position will be required to leading business requirements sessions, keep the organization apprised of advanced in sales technologies and be responsible for the evaluation of new CRM technologies to support current and future business strategies. This position is also responsible for leading project management of technology enhancements or new implementations, managing all aspects of the projects including; vendor management, project planning, leadership alignment, alignment with IT and user acceptance testing oversight.This position will be expected to build a strategic partnership with the field sales teams to ensure an on-going understanding of utilization, effectiveness and future needs of our field sales technologies. They will be responsible for organizing and leading field focus groups, evaluating utilization and collecting feedback.• Business owner of Customer Relationship Management (CRM) solutions and represents the needs and interest of all Otsuka’s therapeutic area field forces and acts as primary point of contact to the field force for CRM specific communications and change management efforts. • Works closely with field force leadership, collecting field force feedback on field technologies, processes and overall effectiveness. Tracks and communicates utilization and field support level metrics, ensures enhancement requests are prioritized with business objectives, authors’ communications for enhancements and leads change management efforts. • Provides support and works closely with Sales, Marketing, Managed Markets, Field Force Effectiveness, Promotional Program Management, Legal & Compliance, Segmentation & Targeting, Business Analytics, Master Data Management, Information Governance, Co-Promoters and Business partners on defining business needs/requirements for field force automation initiatives.• Works cross-functionally within Sales Operations to ensure that field technology strategies are aligned with broader organizational initiatives.• Partners with Learning and Development on the delivery of Field Force New Hire Training and other required training for sales technologies.• Works with SOPs & OIT and Business Service on overseeing Tier-1 helpdesk activities, and ensure user issues and questions are addressed in a timely manner with high quality. This includes training of help desk specialists, defining SOP’s and SLA’s, evaluating of help desk metrics, and proactively soliciting user feedback, etc. • Partners with IT in the analysis, design and implementation of new CRM applications, enhancements, feature releases and special projects, including defining roadmaps and project plans, project status reports, issue logs, testing plans, training & transition plans, etc.• Develops and maintains stringent quality control process and measures that ensure the accuracy of all CRM information disseminated to the field force. Assists maintaining the integrity of enterprise data systems and supports enterprise information governance efforts. Partners with IT to evaluate opportunities for improved efficiency and effectiveness of technologies include data processing, technology response times, etc.• Serves as PM/PMO lead, manages tasks, dependencies, issues & risks across Sales Operations initiatives and formal projects, including the coordination with other commercial organizations, OIT, vendors, Co-promoters and other business partners to ensure completion on time and within budget. • Supports system integration testing (SIT) and coordinates user acceptance testing (UAT) for CRM projects including authoring testing plans and test scripts, tracking testing results, defining tollgates and testing closure.
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The Account Manager is considered to be skilled or advanced in their demonstration of account management capabilities and sales proficiencies. This individual contributor is self-sufficient and able to apply skills successfully in all situations. Specifically the Account Manager will demonstrate ability in the following areas: Local Market Expertise - Ability to collaborate with internal and external partners to gather and validate key trends and dynamics in the market, map account linkages including stakeholders that exhibit direct and indirect influence on customer behavior. Utilize market knowledge to uncover and prioritize unique opportunities that will allow for mutual value between Otsuka and our customers Reimbursement - Consistently demonstrates the ability to stay informed on reimbursement dynamics, anticipate and communicate impact on product portfolio to key internal and external partners and problem solve payer access issues (Medicare, Medicaid, Commercial) through the use of Otsuka resources Business Planning and Execution - Ability to prioritize opportunities, develop strategy & tactics,, allocate resources, monitor progress and adjust direction in an effort to maximize sales performance and measure progress against plan Critical Thinking - Ability to understand a situation, issue, or problem by breaking it into smaller components. Ability to collect information, derive inferences, find solutions and make informed decisions and recommendations using data and tools where appropriate Pharmaceutical Environment - Ability to apply knowledge of pharmaceutical and regulatory environment, including Otsuka policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply knowledge of overall healthcare economy and industry practices Therapeutic Area Knowledge - Ability to apply therapeutic area knowledge to the sale of Otsuka’s products and/or to increase effectiveness in role Customer Development - Build and maintain productive internal and external relationships (e.g. customers, account contacts, stakeholders and influencers e, etc) based on customer needs and organizational goals Selling - Understand the core selling process, adapt style, and effectively negotiate to bring value to the customer and close the sale Key Job Responsibilities: Drive for Results -Can be counted on to exceed goals successfully, is constantly and consistently able to develop top performing teams, very bottom-line oriented, steadfastly pushes self and others for results. Peer Relationships - Can quickly find common ground and solve problems for the good of all, can represent his/her own interests and yet be fair to others, can solve problems with peers, direct reports and matrix team members with a minimum of noise, is seen as a team player and is cooperative, easily gains trust and support of colleagues, encourages collaboration. Critical Thinking Establish standards for collecting and organizing data to assess business trends, opportunities Summarizes complex situations or data sets into easily understood information Makes critical decisions using information gathered and develops others in their ability to organize their thoughts, identify patterns in data, and facilitate decisions making Leads broad problem solving efforts and guides others in identifying and analyzing problems and determining solutions Business Plan Development and Execution In collaboration with key internal and external partners can effectively (consistently and accurately) lead all components of a business plan (milestones, tactics, budgets, resources)Continually analyzes performance against plan and is proactive in planning sales activities to maximize customer calls and impactAble to write an integrated plan, which can be used during execution of multiple projects Manages multiple constituents at various levels of the organization to drive towards meeting timelines and milestones Evaluates the results of timelines and resource plans and recommends changes Evaluates regional performance vs. external benchmarks and works with Regional Directors to coordinate internal resources to improve performance benchmarks External Partnerships Coordinate with alliance partner sales management team within region geography Customer Management Manage key account coordination along with the District Managers to develop relationships leading to increased profitability and better patient outcomes Compliance Management Ensure full and complete compliance of all selling activities within the area of responsibility to OAPI standards and to all state and federal regulations Comply with the letter and spirit of all State and Federal laws, regulations, and guidance as well as PhRMA Code on Interactions with Healthcare Professionals and OAPI standards and policies relating to all promotional activities Identify risks and issues associated with non-compliance and implications of regulatory infractions Qualifications
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The Associate Manager Clinical Pharmacology supports the nonclinical/clinical pharmacology departments by managing the preparation and delivery of Nonclinical and Clinical Pharmacology regulatory documents, including but not limited to study reports and regulatory submission documents, and managing or working with the requester of services (ROS) on contracts and payments for external vendors. In addition, the Associate Manager will oversee data flow and data integration systems and ensure appropriate archiving.Job Responsibilities• Generate timelines of key deliverables for the Nonclinical and Clinical Pharmacology teams, specifically internal and external reviews and submission deliverables. • Attend and represent the Nonclinical and Clinical Pharmacology teams at project meetings related to submission activities and communicate project deliverables to key stake holders• Ensure project deliverables comply with established practices, policies, processes and SOPs• Work with nonclinical and clinical pharmacology team members in the US and Japan to provide feedback on internal and external initiatives. • Serve as the regulatory compliance lead by participating in computer system validation efforts • Identify and/or support the evaluation of quality systems to ensure quality and enhance efficiency• Oversee the archiving of nonclinical study samples, in coordination with the program lead• Independently of and with support of the ROS, manage financial activities of external vendors, including SOW, contract execution, and invoice reconciliation for Clinical Pharmacology and non-clinical teams. • Arrange for timely review of templates to ensure compliance to regulations, and internal policies and procedures • Independently or in collaboration with key stake holders, manage QC of internal and external Non-clinical and Clinical Pharmacology reports and regulatory submission documents• Ensure regulatory submission documents meet standards of the Otsuka Style GuideServe as the CREDO administrator for clinical pharmacology and nonclinical
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TheSenior Scientist Clinical Pharmacology will help develop and implement clinical pharmacology programs that support product development, registration, differentiation and personalization. The Senior Scientist will interact with team members to identify and define mechanisms of action, biomarkers and new drug targets. The Senior Scientist is expected to help design clinical pharmacology trials and select pharmacokinetic (PK)/pharmacodynamic (PD) /biomarker assessments in all phases of development, work on development of physiologically-based pharmacokinetic (PB-PK) models extrapolating animal to human and within human for prediction of changes in PK with new formulations, disease state, pediatric, etc., conduct PK/PD analysis and reporting, contribute relevant sections to regulatory filings, work with pharmacometricians to develop PK/PD models and contribute to commercial strategies.- Help develop and execute Clinical Pharmacology strategy for given programs- Collaborate with clinical development to design and implement innovative early clinical development strategies from first-in-man through pharmacological/biomarker proof of concept (Phase Ib/Phase 2a)- Identify new drug targets and biomarkers through analysis of drug mechanism of action and patient characteristics (e.g., phenotype, genotype, etc.)- Provide input to project teams on biopharmaceutics, pharmacogenomics and biomarkers.- Work on development of physiologically-based pharmacokinetic models extrapolating animal to human and within human for prediction of changes in PK with new formulations, disease state, pediatric, etc.- Help design clinical pharmacology trials and is responsible for the generation of protocol outlines- Coordinates with bioanalytical scientists on types of analytes, limits of quantitation, and response range required of the bioanalytical methods used to support clinical trials.- Analyzes PK and PD data using non-compartmental and compartmental methods and prepares PK and PD sections of study reports and regulatory submissions documents.- Works with pharmacometricians to develop PK/PD/efficacy models.- Prepares and may present PK/PD information to internal clinical development and commercialization teams, regulatory agencies, and scientific boards and at investigator meetings.- Provides input to Department Head on departmental practices, templates and workflows.- Minimum of 5% travel based on business needs
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Aligning with the strategic goals of the GQ organization, the Sr. Manager of Global Quality Solutions (GQS) is responsible for understanding and driving intelligence across Global Quality’s processes and operations via automation and digitization; serving as an enabler of transformation across existing GQ technology, future processes and teams. The Sr. Manager position will facilitate pilots, prototypes, collaborations and projects to digitize various Global Quality processes that drive to bring intelligence. The Sr. Manager of GQS coordinates with applicable business functions (i.e., Otsuka Data Sciences, Otsuka Information Technology, Applied Innovation and Process Improvement, etc.) to advance Global Quality forward to a digital transformation of the entire GQ workspace via the optimization of applicable systems and workflows, the adoption of automation, and the promotion of a GQ culture driven by state-of-the-art data insights. The Sr. Manager introduces industry best practices from a variety of disciplines and solutions (i.e., quality, automation, machine learning, and artificial intelligence, etc.) to deliver on the GQS strategic roadmap across all Global Quality practices to a best in class – digitalized landscape. - Lead various workstreams within the GQ intelligence strategy to establish an automated, digitized and ever-green environment- Direct leadership in digitalizing the processes and practices of Document Management (i.e. Iron Mountain) and eliminating (or significantly minimizing) any paper archive.- Applying technology intelligence and understanding of the process enhancement requirements, determining opportunities for optimization of existing systems and identifying the need for new solutions.- Addressing digitization of paper documents across the ecosystem of GQ to enable e-archiving and e- access and retrievability.- Design and employ a digital and automated GQ work flow across the enterprise of the GQ business function.- Drive a culture of Quality Innovation awareness through benchmarking external opportunities, innovation advancements and ensuring Otsuka GQ is at the cutting edge of the use of innovative processes, practices, solutions and technology.- Drive optimal operational efficiency and effectiveness.- Assist GQS Leadership in delivering on the design and execution of complex GQ optimization initiatives including; detailed program planning, well-defined business cases, clear value proposition, management of applicable collaborators and identification/leveraging of applicable external expertise. - Support the evaluation, measurement and documentation in time, resource and cost optimizations of continuous improvement and transformational activities to ensure improved efficiency and effectiveness over time. - Assess opportunities through internal and external collaborations to optimize GQ processes, the timeliness and quality of GQ deliverables, and GQ resource requirements using transformational technologies such as, Robotics Process Automation, Machine Learning, Artificial Intelligence and Blockchain capabilities
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As a Sr Manager, Human Resources Business Partner, you will be a champion of Otsuka’s culture and values, partnering with our business leaders to help them build their organizations. Employee Relations plays a key role in this position. The successful candidate consults the businesses they support, demonstrates Otsuka culture in their decisions and behavior, monitors the effect of business decisions on people and advise management appropriately. This individual is not afraid to challenge the status quo. The successful person is learning agile and able to deal with ambiguity while translating complex issues into clear and coherent solutions.Responsibilities include but not limited to the following:- Highly skilled in managing employee relations issues including participation in internal investigations and providing recommendations for resolution- Work closely with management and employees to improve work relationships, build morale, increase productivity and retention- Proactive partner with the business on complex organizational challenges and manage people-related solutions- Functional support to R&D, Shared Services and other functions as needed.- Understand every aspect of the business and contribute as a thought-leader regarding People and Organizational topics- Think big, use analytics to guide your work, be comfortable challenging convention, and in some cases, reinvent how work is done- Partner with a cross-functional group of subject-matter experts to design and execute strategy for how we staff, onboard, develop, motivate, retain and organize work- Partner with Business Leadership and HR team to ensure consistency of approach, message, and execution using proven tools in line with competency model- Support the implementation of major changes on people and the organization- Collaborate with HRBP team to ensure the cross-functional impacts are recognized and addressed- Reinforce a performance management strategy that provides clarity of direction, reliable measurement and clear feedback, drives accountability, focuses on coaching/development, and is underpinned by Otsuka core values and competencies- Contribute to the development of talent acquisition and pipeline strategies as well as employee development strategies – including temporary staffing to executive placement. - Partners with HR Operations (Total Rewards, HRIS, and Payroll) and Talent (Talent Management, Talent Acquisition, and Performance Management) to ensure life cycle transactions are managed in an organized and consistent manner using proven tools and assessments- Manage the delivery of cyclical programs to business clients ensuring consistency across HRBPs- Partner with client groups to support all yearend initiatives including compensation recommendations- Provide guidance and input on organization design, restructuring and resource optimization initiatives- Demonstrated ability to manage multi-business employee relations needs- Provides proactive and reactive advice and counsel to managers and supervisors regarding people practices, policy and employment laws. - Experience with University relations and internship programs. - Ensures compliance with all state and federal discrimination and employment regulations.
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The Manager, Patient Support Strategy is responsible for helping to establish a patient support strategy across the Otsuka Portfolio of products, serve as a contact for all cross-functional product support and collaboration, and ensure the patient support vision and objectives are upheld. This position has been designed to help the organization grow and expand in the patient support spaces, where our products are utilized. This position will report to the Associate Director, Patient Support Strategy. Responsibilities:• Responsible for helping to establish a patient support strategy across the Otsuka portfolio of products• Identify Patient Support needs, liaise with internal stakeholders, and establish appropriate Otsuka patient support programs:o Assist with strategic support planning and executiono Integration of support resourceso Alignment of strategy, objectives and tactics and budget• Assist with marketing agency relationship for launch products and therapeutic areaso Responsible for development and distribution of patient support program communication assets (print and web)o Support collateral development for Trade & Specialty Channels teamso Collaborate with Brand teams to ensure on-time delivery of Patient Support materials• Participate on patient support advisory boards and market research projects• Exhibit proficiency in reimbursement landscape/ disease state to ensure program, resources and materials are relevant for patient population• Collaborates with Patient Support leadership, Legal and Ethics & Compliance to ensure appropriate field education/ awareness of program offerings and to ensure vision and objectives are upheld• Support tactical execution of Patient Support plans by:o Resource developmento Budget management: Driving implementation of new initiatives as well as planning for future initiatives
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Key responsibilities include but not limited to the following:Solution Ownership- Designing, implementing and supporting development and business processes in an Ariba environment.- Designing Ariba technical solutions, identifying RICEFs (Reports, Interfaces, Conversions, Extensions, Forms) design and development- Understanding the overall solution architecture and integration requirements with Oracle, SAP S/4 HANA and other legacy applications- Understanding of the integration cloud integration methods like API’s, Cloud Integration Gateway- Identifying and addressing internal client needs: actively participating in design/solution discussions and meetings; managing Ariba changes and enhancements including preparing concise, accurate documents and balancing project economics management with the occurrence of unanticipated issues- Creating a positive environment by monitoring workloads of the team while meeting client expectations and keeping leadership informed of progress and issues. - Technical/Functional expert in at least one Solution Area/Component- Cross-organizational lead/go-to for Solution Area(s)/Component(s)- Working closely with the Enterprise architecture team to develop solutions to support the Source to Pay process- Product issues both Customer (incidents) and non-customer (health monitoring) reporting- Multiplication of solution knowledge across entire organization (how things work and why)- Driving visibility and knowledge of new product Enhancements and roadmap- Product Supportability and Customer Adoption- Develop strong partnership with SAP Ariba shared services team, Supply Chain and Finance teams to make key decisions and drive solution Incident Engagement- Engage with Mission Critical Support on high impact incident analysis- Provide solutions to complex/high impact issues- Provide workarounds/alternatives to prevent excessive customizations- Validation of escalated Enhancement Requests prior to Solutions Management engagementKnowledge Transfer- Externally and internally recognized as a noted leader/expert in product area(s)- Coaches/engages/mentors others to multiply knowledge across the entire organization- Partner with cross functional to improve documentation gaps and identify usability issues
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This position will report to the Head of US CNS Portfolio Optimization and will drive the commercial strategic framework of the US CNS portfolio. This individual will be required to work collaboratively across the Otsuka CNS organization to develop aligned, cohesive, integrated commercial strategies designed to optimize OAPI CNS revenues on a mid to long-term basis. This will include ensuring alignment with key stakeholders such as CNS Sales and Marketing leadership, the US-based OPCJ Global Marketing team and others.Specific responsibilities include but are not limited to:• Establishing aligned portfolio optimization framework and key associated deliverables• Driving US CNS portfolio strategies based on a deep knowledge of commercial markets, customer insights and competitive intelligence • Partnering with marketing and sales teams to optimize the portfolio, including messaging, positioning and tactics and informing development strategies through strong commercial insights• Ensuring strategic coordination between product strategies• Partnering with key internal stakeholders with a focus on marketing, early commercial development, medical affairs, launch excellence, customer insights, HEOR and market access to ensure strategies are focused on maximization of revenue across the portfolio• Proactively leading and contributing to portfolio strategy, driving the development of new ideas and new business and coordinating input from cross-functional, cross-company teams• Building strong networks within the company to identify and pursue opportunities • Managing and delivering portfolio strategy by developing cross-functional teams, assessing risks, driving conclusions, and reviewing/challenging the output produced by the teams• Working with internal analytics teams to conduct effective portfolio strategy valuations• Developing strategies to solve complex commercial challengesKey Deliverables• Mid to long- term portfolio optimization strategies that are aligned across the organization and implemented• Commercial viability assessments from CNS portfolio perspective• Input into CNS and Brand Strategic Plans (LCM component)• Input into New Product Commercialization/Global Marketing team and Strategy team planning to ensure the portfolio perspective is included
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This position is part of a high performing team that provides actionable, innovative solutions to address key business questions & opportunities. The position requires a person who can work independently with limited supervision and feel comfortable working across a complex matrix environment including interaction with third party vendors and consultants, OAPI management and current and potential partner companies. Documented expertise in a variety of disciplines is a plus in this position.This position requires specialized knowledge of and experience in pharmaceutical industry analytics in general and Targeting/Sales Force Optimization practices in particular.• Understand organizational/brand strategy to develop Targeting Criteria• Responsible for planning, development, oversight, and timely deployment of Target Lists and Call plans ensuring full compliance with all regulations and SOPs.• Leads content development, coordinates and co-facilitates Executive Target Review Committee meetings. • Working with cross functional teams, translate organizational strategy into actionable targeting plan• Develops and maintains stringent quality control process and measures that ensure the accuracy of all reports and information disseminated.• Work closely with contractors and external suppliers to increase and enhance the use of advanced modeling and analytic methods and produce results that fully leverage available data and analytics.• Flexibility to adapt quickly to new roles and or responsibilities in dynamically-evolving business • Ability to work with ambiguity and lead deep dive analytics on Business Performance with cross- functional teams whose members consist of Brand Marketing, Target Review Committee, Sales Operations, Payer Marketing and Payer Account Executives
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Provides financial planning and analytic support to brand teams and various departments. Expected to work with Brand and Department leads to develop and manage budgets and forecasts, review actuals, provide analysis of variances and identify opportunities for more efficient use of resources, including development of business cases to support additional investment opportunities. Required to utilize reporting packages, databases and data visualization tools to analyze and communicate information to senior level financial and non-financial executives. Perform NPV, ROI/IRR calculations for internal projects and business development activities. Key responsibilities include but not limited to the following:- Partner with Brand Teams and Departments to deliver financial commitments – act as financial advisor for business, including: - Coordinate and develop actual results, budgets, forecasts and long-term plans per Financial Planning Calendar- Understand and communicate key drivers of performance and Budget variances for expenses and revenue - Identify areas of opportunity for spending efficiencies- Incorporate and share Financial Stewardship principles across the commercial team- Help manage accrual and accounting process across the business, and provide business with uncommitted and unspent funds- Understand the underlying financial risks and opportunities for each department.- Use financial analyses and data visualization tools (PowerBI) to help measure, communicate and prioritize results and investment decisions.- Develop and maintain analysis reports that help client and senior management better understand and manage the business.- Support and help manage data integrity, including summarizing all types of expenses.
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This role leads the operations of the Procure to Pay Center of Excellence. Responsibilities in this position will include the timely, efficient, accurate and cost-effective processing of transactions, management of onshore and offshore staff, and ensure maintenance of internal controls and compliance with statutory requirements. This role will support the procure to pay process within Ariba, ensure contracts compliance and ensure timely and accurate processing of purchase orders. This position will also support continued process improvement, assist in managing projects which drive efficiency and productivity through the department and create an environment of continued growth and development of staff and resources. The Associate Director of Procure to Pay will deliver a customer service focused framework while monitoring service level agreements (SLAs) through effective management of key performance indicators (KPIs) and other key metrics. Key responsibilities include but not limited to the following:- Responsible for the Procure to Pay process, Ariba Contracts compliance, Ariba buying and Invoicing- Coordinate with representatives from other departments and suppliers to ensure timely and accurate supplier collaboration, PO confirmation, invoicing and problem resolution- Provide leading practices and guidance on procure to pay process and best use of Ariba modules- Coordinate with Ariba administrator and Ariba support for implementation of enhancements- Coordinate with the supplier enablement and catalog management team to incorporate enhancements- Coordinate with AP and shared services team to ensure accurate invoice exceptions and tolerances are configured and provide functional subject matter expertise for resolving issues and discrepancies - Provide functional expertise to determine the best invoice intake strategy - Translate business requirements to functional designs and have the ability to explain / work with the IT programming team to complete the implementation- Assist on any testing activities- Work with global team to coordinate other rollouts
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This role leads the operations of the Accounts Payable Center of Excellence. Responsibilities in this position will include the timely, efficient, accurate and cost-effective processing of transactions, management of onshore and offshore staff, and ensure maintenance of internal controls and compliance with statutory requirements. This role also supports continued process improvement, assists in managing projects which drive efficiency and productivity through the department and creates an environment of continued growth and development of staff and resources. The Associate Director of Accounts Payable will deliver a customer service focused framework while ensuring accuracy in invoice intake/payments and contributing to the development and monitoring of service level agreements (SLAs) through effective management of key performance indicators (KPIs) and other key metrics.- Subject Matter Expert in the Payables process within ARIBA for the Accounts Payable function. Play lead role in the development of the future processes;- Drive the appropriate change and identification of efficiencies to streamline and improve the user experience and vendor interactions by partnering with purchasing, contracting and the business;- Responsible for performance of cycle times with visibility to measure against best in class benchmarks by developing KPI’s and dashboarding for reporting to Senior Management;- Oversees the development and updating of training materials and desktop procedures for use by onshore and offshore team;- Point person for the management and maintenance of Accounts Payable Service Level Agreements held with offshore provider;- Manage the day-to-day payables process from invoice intake to payment;- Responsible for month end closing activities, including adherence to timelines, accuracy of payables balances and ledger postings and review of month end reconciliations;- Reviews reporting including but not limited to transactional tracking reports, AP aging, KPIs- Act as lead resource in invoice resolution;- Support annual audits for the Accounts Payable function;Key responsibilities include but not limited to the following:- Plan, organize and coordinate the Payable process;- Establish policies and procedures in compliance with Payables best practices and IFRS standards;- Lead department wide improvement efforts in processes/procedures to increase efficiencies while still ensuring accuracy/timeliness of on-going information required by stakeholders;- Build, develop and lead teams to drive higher levels of performance and overall results;- Work to reduce cycle times and understand bottlenecks;- Provide leadership, mentoring and coaching to the team and others as needed- Support Business Projects including integrations, Ariba enhancements, etc.;- Drive process improvements;- Engage and educate business owners;- Interact with Senior Leadership;- Focus on process excellence and data quality.- Support both internal and external auditors;- Work closely with internal controls to ensure J-SOX compliance;
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The Director, Population Health Digital Medicine is responsible for leading health economic and outcomes research studies working with cross-functional teams. Responsibilities will also include but not limited to the following: - Development and implementation of evidence generation strategies including health system level process of care/quality improvement studies. - Will work collaboratively across internal and external stakeholders to focus research and associated communications to support the clinical, economic and humanistic value proposition associated with the Otsuka Digital Medicine portfolio. - Design and implement health economics and outcomes research strategies and associated studies that support the clinical, economic, and patient centered value propositions, as well as reimbursement requirements for Otsuka products and therapeutic areas of interest (primary focus in the US).- Generate and communicate evidence to support the value proposition of Digital Medicines to inform/support product reimbursement discussions and value-based contracting.- Supports the development of clinical, economic, and patient centered value propositions related to Digital Medicine -Assists cross-functional teams in developing and communicating product value propositions in support of policy and coverage decisions consistent with FDA guidelines for communication of healthcare economic information.- Develop product dossiers and other projects that support different aspects of formulary review and submissions.- Develop process and quality of care tools to support formulary decision making and treatment of appropriate populations.- Supports training of field-based medical and access personnel.- Participate in various cross-functional project team and leadership meetings. - Identify and oversee vendor activities in support of evidence generation activities within budget and quality expectations.- Represent Otsuka at external professional, scientific meetings and forums- Support preparation payer advisory meetings to solicit feedback on Otsuka products and therapeutic areas specific disease impacts.- Works collaboratively with market access team to support the development of US pricing and reimbursement strategies.
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We are a company that believes in performance excellence, which is based on a framework of Performance, Leadership, and Continuous Improvement. We will accelerate our sales growth through the leadership and development of our people to outperform the competition. Position Summary:The Nephrology Account Manager contributes to OAPI’s overall sales objective by performing assigned sales related activities. Provides hospitals, physicians, pharmacists and healthcare providers with products, services, and information that will enable them to use and prescribe OAPI products safely and effectively.We are looking for individuals who are highly motivated, learning agile, and can grow in a Commercial organization.Otsuka-people who:- Think differently by challenging conventional thinking- Are intellectually curious and life-long learners- Are effective, ’get it done’ and have a sense of ownership- Are comfortable with ambiguity, autonomy and recognize that innovation is at its best when people connect- Are remarkable in their chosen fieldKey Job Expectations/Responsibilities:- Ensures full compliance with drug laws, regulations, and OAPI policies in all aspects of interactions with healthcare professionals- Achieves the assigned sales objective for the territoryEffectively manages the formulary process to ensure product acceptance to assigned hospital accounts by establishing credibility with key hospital stakeholders, performing timely formulary review for products, expediting formulary acceptance of product, implementing effective plans for product pull-through, and organizing in-services to communicate appropriate approved product information to appropriate hospital personnel on all shifts- Attains the designated goals for calls on appropriate accounts and healthcare professionals- Communicates balanced, accurate, and complete information on OAPI products- Executes calls on pharmacists in order to provide product information and to ensure the availability of OAPI products in assigned accounts within the territory- Collaborates with market access team for formularies and product availability- Demonstrates consistent completion of all administrative requirements in a timely manner, including call reporting, budget management, log-ins, etc.- Completes all required training courses and continually updates product knowledge- Assists district manager in training new Nephrology account managersCompliance Management:- Ensures full and complete compliance of all selling activities within the area of responsibility to OAPI standards and to all state and federal regulations- Complies with the letter and spirit of all state and federal laws, regulations, and guidance as well as PhRMA Code on Interactions with Healthcare Professionals and OAPI standards and policies relating to all promotional activities
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• The successful candidate will be results-oriented with concerns for quality and collaboration. They will show initiative and want to continue to develop and acquire new expertise• Responsibilities of this position will include collaborating with Otsuka Japan, Otsuka affiliates and alliance partners on an effective and efficient process for the global distribution and tracking of labeling updates for products• Disseminates and tracks approved labeling documents and supporting documentation for labeling compliance distribution and implementation requirements• Team with Label Strategist to:o Conduct international labeling operations activities to support global new product and supplemental applications from product registration, through post approval launches for impacted international marketso Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control• Populate and maintain labeling systems; follows FDA postings e.g., DailyMed, Drugs@FDA to ensure current • Responsible for executing and effective quality control reviews and tracking (primarily) internal labeling documents (Core Data Sheet, Core Patient Information Leaflet, Core Instructions for Use) and outward facing local/regional labeling (USPI, Med Guide, EU SmPC, PIL, Canadian Product Monograph, Instructions for Use) as well as container and carton labels to meet regional regulatory requirements and ensure consistency between labeling, labels and supportive documents. • Act as operational expert for the Global Labeling tracking in RIMs • Ensure development and maintenance of templates, collaboration features and system upgrades• Support SPL generation, including drug listing and establishment registration activities. • Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading / editing skills and compiling supportive documentation• Support labeling inspection/audit readiness activities• Serve as a Global Regulatory Affairs contact for PSMF activities • Collaborate with the Global Labeling Team to review and monitor safety variation tracking compliance metrics for CCDS related Safety Changes• Ensures that all labeling components are appropriately maintained according to relevant laws and regulations.• Ensures compliance with new formatting and quality requirements and monitors and determines their impact on product labeling• Proactively suggests improvements to labeling policies, processes, quality, and system tools• Tracks all labeling changes and implementation for assigned regions• Review and monitor compliance metrics for end to end labeling process• Acts as labeling operations subject matter expert when a new labeling technology and/or system is being evaluated• Solid understanding and interpretation of US labeling regulatory requirements preferred • Solid understanding of requirements for tracking of labeling updates• Solid understanding of the structure of the product labeling• Solid understanding of the pharmaceutical industry drug development process• Attention to detail• Ability to recognize and escalate issues• Strong written and oral communication and organizational skills • Problem Solving• Prior experience with document management systems and/or electronics submissions is required.• An aptitude for the use of IT systems; preferable that they have knowledge of Documentum/electronic document management, Regulatory Information Management Systems (RIMS), XML-based and comparative text quality control systems. Proficiency in standard office technology, including Microsoft Word/Suite, Outlook Mail/Calendar and willing to learn additional applications as needed• Proofreading of labeling documents• Assist Global Labeling Leads with other tasks as neededThe ideal candidate should be action oriented, customer focused, can manage workloads, and set priorities. In addition, he/she should be capable of dealing with ambiguity and be comfortable working with multifunctional teams.
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Position SummaryThe Manager, Regulatory Affairs serves as regulatory representative to Project Teams for assigned projects or products and provides regulatory tactical support and strategy. Liaises with regulatory agencies in order to expedite approval of pending registration and answer questions. Ensures that clinical trials meet regulatory requirements as designed. Prepares and ensures rapid and timely submission of new drugs and maintain applications to sustain approved status of marketed drug. Recommends guidance to Project Teams on steps necessary to comply with newly enacted regulations and guidelines.- Recommends regulatory requirements for clinical and pre-clinical submissions to FDA for assigned investigational and marketed products.- Conducts regulatory research and intelligence to appropriately guide Project Teams.Responsible for the overall quality of regulatory submissions. Manages, Reviews and organizes documents intended for submission to FDA to assure compliance with regulatory standards. Provides appropriate regulatory guidance to Project Teams for the development of the above regulatory submissions.Interacts with Project Managers at FDA (pre and post submission). For assigned projects, provides effective oversight for regulatory submissions that are outsourced.
