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The Senior Manager HRIS Guides and participates in development and production support of cloud-based applications used for people data management, payroll and timekeeping (Workday and ADP). Collaborates with HR, Finance and IT stakeholders, providing subject matter expertise, to plan, evaluate and support current requirements and long-term objectives. Functions as stakeholder partner by playing a significant role in planning and managing projects related to new functionality, process improvement and system update release management. Plans and leads system support and optimization projects primarily focusing on support of HR and Payroll systems. Also focuses on implementing improved processes, best practices and operational measures for improved application support across HR and Payroll applications.Essential Job Functions include but not limited to the following:- Provides leadership and general oversight of HR and Payroll systems (Workday, ADP, SuccessFactors).- Facilitates discussion to understand the business and information needs of HR, Payroll and management.- Analyzes and makes recommendations regarding system and process enhancements to streamline HR and Payroll operations system supported processes- Acts as a liaison between key business areas to work with and educate users on applications, technology in support of business processes and enhancements.- Focuses on optimizing efficiency, ensuring data integrity, and safeguarding system security/data privacy with a commitment to utilizing best practices.- Coordinates and guides project and support (internal and external) resources across various project and system support workstreams.- Performs risk analysis with technical and business stakeholders; working with stakeholders to aggressively manage risks to reduce impact on HR/Payroll customers and related projects timelines/budgets.- Develops and updates department policies and procedures as required for project management and support/solution delivery.- Provides full service end user support for systems users in HR and Payroll by troubleshooting problems, analyzing root cause, answering questions, creating and/or modifying reports, and planning/creating documentation as needed.- Actively engages in not only the design/development of, but (hands on) implementation of system configuration solutions.- Oversees the planning, supporting and participating in testing activities.- Protects and supports system security configuration and administration.- Creates and manages security change management protocols, preparing and executing system security audits as required.- Supports business reporting and integration needs from/to support systems and 3rd party providers, including the development of metrics and dashboards for management and HR business partners.- Maintains strict confidentiality and security of corporate Human Resource and Payroll data.- Maintains professional and technical knowledge by: review of professional publications; staying current on industry trends/research; participating in educational workshops/ training courses; benchmarking state-of-the-art practices; participating in professional/ technical user and management groups; establishing/maintaining personal networks and user group memberships
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The Corporate Attorney–Corporate Affairsprovides legal support for clinical development and commercial activities of the company. **Please note that this position can be located in either in Princeton, NJ or Rockville, MD. If located in Rockville please note expected travel to Princeton as required which is in addition to required travel for role. Responsibilities include but not limited to the following:- Provides legal review of contracts, protocols, informed consents, and scientific communications. - Drafts, reviews, and manages a variety of contracts, including vendor agreements, license and supply agreements, complex corporate agreements, employment agreements, research agreements, clinical trial agreements.- Provides legal review of promotional materials and activities, grants and medical education activities.- Provides support for litigation, human resources, finance, operations, compliance, licensing, trademark, and copyright matters.- Offers guidance to project team activities to ensure compliance with company policies and legal/regulatory requirements.- Provides legal guidance for compliance activities.- Other duties and responsibilities as assigned.
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The Applied Innovation and Process Improvement Team is responsible for driving business transformation, streamlining operations, and applying new solutions to simplify business processes to deliver on strategic objectives and critical initiatives. The team is charged with innovating and delivering solutions at the intersection of technology and therapeutics to transform OPDC clinical trial model, while paving the pathway for therapeutic solutions for patients. The Director of Applied Innovation will have the ability and access to influence at both the operational and executive levels of Otsuka across the R&D and Commercial organizations. The focus for this position is to identify areas of creative solutioning to solve complex business problems by leveraging organizational effectiveness, process alignment, transparency, and accountability. The Director serves as a key liaison to functional leaders and their business units. This position facilitates planning, prioritization, change management and reporting between groups to deliver successful outcomes. The role serves to bring cross-functional teams together to ensure project objectives are clearly defined and achieved while business operations and processes are continually refined - to enable successful sustainability and scalability. The Director is a senior member of the Applied Innovation Team with the primary responsibility for driving innovative solutions and spearheading integration of health technologies (i.e., data, wearable devices, clinical devices, sensors and applications, etc.) and transformational technologies (i.e., AI, AR/VR, ML, etc.). The individual will be a driving force for cross-departmental innovative solutions by guiding Communities of Practice (CoP) to execute on pilots and or prototypes. Identify and implement continuous improvement activities - producing tangible outcomes, and overall process harmonization.Job Responsibilities:- Serve as Innovation liaison to key functional areas for identifying opportunities to improve outcomes related to clinical trials and business operations.- Serve as subject matter expert (SME) with academic and technology companies to identify clinical and data opportunities to increase Otsuka’s probability of success in bringing improved treatment options to patients/caregivers/providers/payers (i.e., AR/VR, adherence tools, AI, wearables, etc.).- Guide Communities of Practice (CoP) as a thought leader and SME to innovate at the intersection of technology and therapeutics to propose and execute on critical projects.- Provide leadership and support on pilots, prototypes, and in beta testing that validate and explore ideas to improve how Otsuka conducts and improves its general business.- Promote positive organizational change by way of a serving as a change agent to ensure successful engagement of teams and the deliverable of initiatives on time and on budget.- Identify areas for employing, building and driving improvements in internal and external communication, leveraging lessons learned and applying technology solutions to establish cutting edge practices- Support driving “Outside-In” and creative thinking, coordinate engagements with external innovation companies/consultancies, promote and further strengthen relationships with investigative sites, lead efforts to increase patient recruitment, retention and compliance, and actively lead cross-functional pilots/prototypes; and play a key role in transitioning pilots/prototypes to full-scale projects- Leverage solutions and contribute to the business results as defined in Corporate Goals and supports the implementation of innovative approaches in the day to day execution of clinical trials
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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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Reporting into the Associate Director, Corporate Communications, the Manager, Internal Communications will manage the development and execution of internal communications initiatives that support business objectives across OAPI and OPDC organization. Key responsibilities include but not limited to the following: - Develop content highlighting Otsuka’s innovation and leadership (Corporate) as well as our Mental Health / Nephrology / Digital Medicine (Brand specific) organizations for appropriate settings. e.g. website, articles, flatscreens, print, etc.- Liaison with corporate communications / public relations teammates to pull through external and social media content internally. - Manage the development and execution of programs that promote employee engagement and culture, and build alignment and support for organization’s vision, strategies and priorities- Support development and maintenance of communications guidelines / templates / processes / procedures- Manage PRC review and approval process for corporate communications - Build and maintain collaborative relationships with department heads/leads to ensure alignment with communications projects and consistency of messaging.
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OVERVIEWReporting to the Director of Business Information management, the Associate Director of IT Services R&D will partner with Otsuka’s Applied Innovation and Process Improvement, Global Clinical Development, and Clinical Management and Business Operations business units. This leader will drive execution of projects for emerging technology and end-user software, manage relationship and demand, and execute the IT Services R&D strategy and roadmaps. DESCRIPTION- Partner with the business functions to anticipate capture, and develop business case for adopting EDC, CTMS, Big Data, software development, etc. across the business functions.- Leverage the platform, infrastructure, project management, application support, and corporate security to assess and select COTS and or software development team teams. - Work with stakeholders at all levels of the organization, working effectively in a global, matrixed, multi-cultural, collaborative environment; evaluate cost-benefit analyses and the total cost of ownership. - Knowledge of FDA regulations, including 21 CFR Part 11, quality standards, ICH guidelines, including GCP, GLP and GAMP - Business-area specific governance at the state, federal and international levels - Strong analytical and technical skills required, including a thorough understanding of how to interpret customer business needs into IT applications.- Drive business and technical requirements analysis, business process modeling/mapping, methodology development, and data modeling. - Overseeing the design, development, and implementation of software and hardware solutions, systems, or products for Pharmaceutical R&D. - Ability to build strong relationships with business stakeholders. - Excellent communication and interpersonal skills - Ability to work with people at all levels of the organization - Ability to work effectively in a global, matrixed, multi-cultural, collaborative environment.
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Otsuka IT is embarking on an ambitious transformation plan. As part of the journey we need to hire a new Senior Director, Commercial IT leader who can help us partner with commercial to drive significant change and digital transformation. We are looking for an IT leader with deep pharma commercial experience, strong change experience, excellent partnering skills and ideally exposure to a product based agile environment. Reporting to the Chief Information Officer, and a member of the IT Leadership Team, this leader will become a driving force of change in both the commercial function and across all of IT. They will drive a refresh to the technology landscape, build a new operating model and partnership model with the business, and develop a strong team of IT professionals. Otsuka is going through a period of substantial growth and the expansion of the commercial team in the coming years will be significant. Keeping pace with the accelerated growth, rich R&D pipeline and globalization of Otsuka in recent years, the Senior Director, Commercial IT will be the primary IT business partner to the Commercial functions. The incumbent will own the design and execution of a plan to re-build and re-platform most of the key commercial systems. We will have a heavy emphasis on digital and cloud and we expect you to bring significant experience in those areas. The envisioned changes will require significant change management and will involve re-building a partnership with the commercial team. Demonstrated success in driving change and building strong, integrated partnerships will be key. This critical role will also be responsible for the identification/ideation, architectural design, and qualification of strategic technology initiatives, software application upgrades, and innovation/experiments. Through portfolio management and executive governance, the incumbent will provide a business/IT partnership which will support driving multi-year business value across the global enterprise, aligned with corporate objectives. The role currently has a group of direct reports as well as a base of outsourced IT Managed Services Providers (MSPs) based in NJ and offshore. Key Job Responsibilities include but not limited to the following: - IT/Business Planning and Strategic Business Technology Road mapping– develop and align IT strategy to business domain strategies and corporate objectives. - Develop and maintain a current systems state assessment, desired end state, and roadmap for achievement.- Customer Relationship/Engagement Management– build strong collaborative business partnerships with the respective business leaders and senior executives across the organization.- Resource Management– plan resource capacity to anticipate skills, volume and velocity requirements for Customer Engagement Services demand.- Create Horizontal Alliances with internal leadership– work together to develop standards, SOPs, and associated SDLC processes in support of providing effective Customer Engagement Services.- Opportunity Investigation/Business Case Development– in collaboration with business stakeholders, provide IT leadership in executing project qualifications and cost/benefit analyses for opportunities and innovations.- Financial Management– in partnership with Finance, accountable for developing, maintaining and monitoring IT CAPEX and OPEX budgets and associated planning activities.- Matrixed Leadership - Lead and influence resources through a matrixed environment in which some required resources do not have a direct reporting relationship.- Industry Knowledge - Keeps current with contemporary knowledge, current trends and issues within the Pharmaceutical and IT industries, providing advice and counsel to our business partners when evaluating technology alternatives and driving strategic technology decisions that enable continuous improvement in operations as well as business transformation.- Magnet for Talent - Accountable for strategies and tactics around recruitment, retention and professional colleague development.
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Regulatory Submissions Associate/Sr. Associate is responsible for activities related to regulatory publishing and submission support to fulfil GRA needs. Seeks to contribute into innovation process while supporting GRA strategy and deliverables. Ensures adherence to established business standards within GRA and cross- functional stakeholders. Collaborates with other global and regional development organizations, affiliates, and in-licensed partners to ensures that project/department milestones/goals are being met.- As an integral member of Otsuka’s regulatory operations team, provides regulatory publishing and submission support.- Ensures assigned submissions are made with quality and on-time.- Acts as primary liaison while coordinating regulatory publishing activities for all R&D functions.- Liaise with OPC-Japan for coordinating and publishing CMC-related content.- Owns delivery of electronic regulatory submissions to ensure processes are followed, as well as quality, budget and timelines are met in accordance with health authority requirements and Otsuka leadership established schedules.- Responsible for preparation, submission, tracking, and archival of paper and electronic submissions.- Assists with development of assigned regulatory operations work instructions.- Establishes and builds collaborative relationships with colleagues.- Represents Regulatory Submissions on various Process Mapping Teams (i.e., INDs, NDAs, Clinical Study Reports).- Responsible for organizing and maintaining regulatory files.- Provides regulatory publishing support to other departments.Location - Candidate can either live a commutable distance from Princeton, NJ or Rockville, MD
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The Otsuka US Legal Team is looking for an experienced Intellectual Property Attorney who can be successful within our ethical, fast-paced, adaptive and collaborative culture. This position can be located in either Princeton, NJ or Rockville, MD. Key objectives will be to identify and pursue strategies to capture innovation especially in digital health and medical device areas, including communicating IP guidance and risks to IP, legal and business teams. You’ll develop and execute far-sighted IP strategy for projects and portfolios worldwide in line with company business goals. You may also work on business development deals or coordinate our response to legal changes. Key Responsibilities Include:- Create and implement global strategic approaches toward building patent portfolios and providing value to business- Prepare and prosecute patent applications in the US and abroad, including effectively managing outside counsel as needed- Manage litigation work by outside counsel in the US and abroad - Provide IP and technical analysis in support of patent litigations- Manage all aspects of intellectual property estates in Otsuka’s core and developmental therapeutic areas, such as digital health, digital therapeutics, and medical devices, including bioinformatics, medical systems, databases, data search and retrieval, and mobile applications- Research, evaluate and monitor patent portfolios of third parties, and develop FTO strategy- Develop and communicate IP guidance to stakeholders across the business, including within Clinical, Medical Affairs, Business Development, Commercial, Marketing, and Legal Affairs- Support intellectual property-related transactional work- Develop an understanding of the Otsuka’s technology, scientific and business strategy to develop and prioritize IP strategies and to identify IP-related risks; advise company management and stakeholders on IP strategies and risks- Perform other legal, administrative and corporate duties upon request- Work collaboratively and strategically with members of IP department in related companies- Review and negotiate contracts for collaboration with third parties regarding IP matters
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The Otsuka US Legal Team is looking for an experienced Intellectual Property Attorney who can be successful within our ethical, fast-paced, adaptive and collaborative culture. This position can be located in either Princeton, NJ or Rockville, MD. Key objectives will be to identify and pursue strategies to capture innovation especially in digital health and medical device areas, including communicating IP guidance and risks to IP, legal and business teams. You’ll develop and execute far-sighted IP strategy for projects and portfolios worldwide in line with company business goals. You may also work on business development deals or coordinate our response to legal changes. Key Responsibilities Include:- Create and implement global strategic approaches toward building patent portfolios and providing value to business- Prepare and prosecute patent applications in the US and abroad, including effectively managing outside counsel as needed- Manage litigation work by outside counsel in the US and abroad - Provide IP and technical analysis in support of patent litigations- Manage all aspects of intellectual property estates in Otsuka’s core and developmental therapeutic areas, such as digital health, digital therapeutics, and medical devices, including bioinformatics, medical systems, databases, data search and retrieval, and mobile applications- Research, evaluate and monitor patent portfolios of third parties, and develop FTO strategy- Develop and communicate IP guidance to stakeholders across the business, including within Clinical, Medical Affairs, Business Development, Commercial, Marketing, and Legal Affairs- Support intellectual property-related transactional work- Develop an understanding of the Otsuka’s technology, scientific and business strategy to develop and prioritize IP strategies and to identify IP-related risks; advise company management and stakeholders on IP strategies and risks- Perform other legal, administrative and corporate duties upon request- Work collaboratively and strategically with members of IP department in related companies- Review and negotiate contracts for collaboration with third parties regarding IP matters
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The Otsuka US Legal Team is looking for an experienced Intellectual Property Attorney who can be successful within our ethical, fast-paced, adaptive and collaborative culture. This position is located in Princeton, NJ. Key objectives will be to identify and pursue strategies to capture innovation in all phases of R&D activities of pharmaceutical business, including communicating IP guidance and risks to IP, legal and business teams. You’ll craft strategies for the filing, prosecution, maintenance and defense of patents worldwide. You may also work on business development deals or coordinate our response to legal changes. Key Responsibilities Include:- Actively counsel members of Clinical Development and Medical Affairs departments to identify new inventions as well as devise and implement strategies for patent protection and publication throughout all phases of drug development and commercialization- Create and implement global strategic approaches toward building patent portfolios and providing value to business in view of pharmaceutical product lifecycle.- Build and manage patent portfolios by identifying inventions and preparing, prosecuting, maintaining and defending patent, especially inventions arising in clinical developments.- Prepare and prosecute patent applications including effectively managing outside counsel as needed- Evaluate and monitor patent portfolios of third parties, including IP due diligence in in-licensing opportunities- Develop and communicate IP guidance to stakeholders across the business, including within Clinical Development, Medical Affairs, Business Development, Commercial, Marketing, and Legal Affairs- Support intellectual property-related transactional work- Work collaboratively with colleagues and leadership in the legal and IP function as well as the Clinical Development and Medical Affairs departments, including substantial interactions with IP function of headquarters in Japan- Develop an understanding of the Otsuka’s technology, scientific and business strategy to develop and prioritize IP strategies and to identify IP-related risks; advise company management and stakeholders on IP strategies and risks- Provide support for patent, licensing, trademark and copyright matters.- Provide IP and technical analysis in support of patent litigations- Perform other legal, administrative and corporate duties upon request
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Serves as the scientific and strategic leader of departmental or clinical program development activities within a therapeutic area, product or group of products within a portfolio. Accountable for scientific content, operational precision and integrity of development plans and ensuring protocols meet requirements for simultaneous regulatory submission and optimal market access. Leads or oversees team driving inspection readiness activities related to assigned trial or program. Leads and champions ideation and implementation of internal and external cross-functional innovation efforts to advance successful execution of clinical trials patient-focused clinical trial design methodologies and technology solutions. Serves as key member representing Clinical Management for governance with ESP (External Service providers) or other partners. Subject Matter Expert responsible for the attainment and delivery of key data that drives outcomes through: Strategic Planning and Implementation- Serves as clinical strategy leader to assigned Compounds, Products or Indications- Co-leads or partners with GCD counterpart(s) to provide critical scientific insight that ultimately drives operational strategy, regulatory submission strategy and defense of attained data (as needed)- Provides life cycle management/brand development strategic support, including strategies to enhance future commercialization of compounds- Coordinates, supports or leads program level inspection readiness strategies in preparation for and defense of global regulatory filings and ongoing marketed products in collaboration with other functional areas Innovation Management- Champions, develops and oversees implementation of overall innovative vision at compound/product/ or program level- Recommends, evaluates, and/or develops vendors and collaborators to improve innovation within conduct of trials or measures of efficacy/safety- Manages innovative solutions in accordance with overall company business objectives- Creates new, possibly disruptive, approaches in clinical trial conduct while maintaining compliance with all applicable GCP concepts and regulationsLeadership- Member of Clinical Management and Clinical Management and Business Operations Leadership Teams (CMLT, CMBO)- Key member of cross-functional, company or industry initiatives and forums- Builds effective teams (Program, workstream/initiative, external partnership or alliance)- Informed and effective decision maker- Continuously develops leadership skills and professional expertiseExpertise- Scientific expertise in one or more therapeutic areas and disease states- Ability and willingness to expand therapeutic knowledge in accordance with company product portfolio needs- Successful track record of execution and program implementation from start to program closure- Ability to perform clinical analysis, interpretation and presentation in the context of current scientific landscape- Substantial contribution to regulatory document preparation and submission from clinical perspectiveAccountability- Accountable for scientific and operational validity of study protocols- Overall accountability for the scope of program clinical budgets- Interacting frequently with senior management related to key program strategies and deliverables and/or related to departmental deliverables significantly affecting the organization- Final escalation point for study/program teams prior to senior management or governance escalation- Responsible for internal and CRO partnership team’s protocol implementation, on time and on budgetPeople Development- Serves as company ambassador in attracting and recruitment of top talent from diverse industry, educational and experience background- Trains and coaches staff- Evaluates employee performance on an ongoing basis and completes annual performance reviews- May manage FTE and/or contractor direct reportsOther Responsibilities- Develops strong scientific partnership with key advisors in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Leads program-related advisory boards/committees and meetings.- In collaboration with the protocol team, leads the ongoing clinical trial data medical/scientific reviews, focusing on data integrity, trending and consistency across the program. Contributes to final analysis and interpretation of data, including the development of clinical trial reports, publications and internal/external presentation- Key member of assigned departmental, ESP partner and/or corporate standardization and continuous improvement efforts- May be assigned solely or primarily to departmental activities
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This individual will report into the market access function, but work cross-functionally with sales, brand, trade, business analytics and commercial partners to drive strategic decisions and tactical programs that provide customer value for payers across therapeutic categories and over the lifecycle of products. The development of promotional and educational materials to support the field account executives calling on payers, GPOs,VA, DOD, and other field personnel is a key deliverable for this function. This position will be responsible for building channel and brand payer strategies, collaborate on creating the value proposition and evidence generation strategy for US payers, segmenting payers, creating personal and non-personal tactics, managing the related budgets and agency support. Additionally, providing insight into pricing strategic plans will be a component of this position. The Assoc Director may also lead strategic market monitoring and expansion projects. The purpose will be to undercover insights that result in expansion, experiments and pilots that could expand business opportunities in these channels.The Assoc Director in this role must have hands-on payer marketing experience developing winning strategies that drive value and access in complex payer markets. This includes an in-depth-knowledge of payer customer environment, buy-and-bill systems, and an understanding of the evolving reimbursement landscape. They must have worked in a payer marketing role or had relevant experiences that demonstrate strategic thinking, driving results and customer orientation.7-10 years in the pharmaceutical industry with the majority of time in managed markets and marketing.• Understand and educate the organization on market access landscape, channels, and strategieso Develop Channel and Brand specific marketing strategies and associated tactics to support corporate and brand objectives and execution requirements thru all resourced Market Access Field teams.o Develop pull through strategies aligned to market access and brand objectiveso Direct Brand specific Market Access Market research activities.o Lead Market expansion opportunity projects• Lead cross functional market access strategy team to deliver an integrated market access strategy for the corporation while aligning to customer value with each engagemento Develop and maintain value message platform for Brand.o Direct and create the necessary promotional tools that support Account Executive efforts with key customers and pull through of payer opportunities in the field with customerso Manages key Agencies of Record to deliver tools and tactics• Lead budget planning process for Manage Market Access Marketing Brand budget resources.• Engages and informs commercial partners.
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Otsuka Market Access – National Account DirectorThis position will be responsible for representing OAPI with the largest and most complex National Payers and or PBM’s. These accounts represent over 90% of portfolio net sales. This includes interacting with all levels of the largest Payers, to include but not limited to C-Level, Medical Directors, Quality Management, key Network Provider Organizations and Contract. National Account Directors will ensure profitable portfolio access across the portfolio while enabling pull-through execution with the internal matrix. This role reports to Senior Director Market Access, National Accounts.• Represent OAPI and OAPI Brands to assigned Payers to include:• Ability to articulate compelling unbranded and branded messaging within PI labeling• Establish OAPI as thought leader in Behavioral Health within assigned accounts• Serve as the knowledge broker to the assigned accounts on OAPI therapeutic areas, US Healthcare Landscape and Access segments of the business• Foster deep customer relationships & collaboration within the account and OAPI assets to include: Sr. Leadership, Medical, HEOR and C&P• Help build compelling Brand Value Propositions that will resonate with our largest and most complex customers• Provide detailed Brand clinical information (approved reprints)• Share approved Health Economic Data and Models• Demonstrate experience to further customer engagement by providing insights/expertise in relevant Therapeutic Areas• Leverage and Champion core market access resources and sales planning tools• Serve as the Market Access point between OAPI and Internal/External Customers to include:• Enable robust account strategy development as part of the Market Access Strategy Planning Cycle as well as Senior level strategic planning,• Lead and bring customer insights into strategic discussions for the OAPI’s internal team while creating innovative and profitable contract proposal that enable portfolio access and exceptional GTN management• Serve as a role model while leading discussions on customer insights on behavioral trends, market conditions, and changes in formulary/medical policies• Provide exceptional leadership during MML/HEOR/Marketing team interactions with Customers to include unique MML engagements and relationship building with peers• Collaborate with Market Access Regional Account Managers/Sales Regional Business Director/District Business Managers/Manufacturer partners to optimize business performance and/or manage complex business risks and issues• Engage with Otsuka Government Affairs and Advocacy to help shape policy input and direction execution against opportunities and threats in area of responsibility• Ensure Account Management CRM tool are up to date with all account activities and Business Plans are robust and up to date• Review and correct Formulary information monthly via MMIT data• Conduct all activities in compliance with all applicable local, state and federal laws and regulations as well as company policies
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Otsuka Market Access – National Account DirectorThis position will be responsible for representing OAPI with the largest and most complex National Payers and or PBM’s. These accounts represent over 90% of portfolio net sales. This includes interacting with all levels of the largest Payers, to include but not limited to C-Level, Medical Directors, Quality Management, key Network Provider Organizations and Contract. National Account Directors will ensure profitable portfolio access across the portfolio while enabling pull-through execution with the internal matrix. This role reports to Senior Director Market Access, National Accounts.• Represent OAPI and OAPI Brands to assigned Payers to include:• Ability to articulate compelling unbranded and branded messaging within PI labeling• Establish OAPI as thought leader in Behavioral Health within assigned accounts• Serve as the knowledge broker to the assigned accounts on OAPI therapeutic areas, US Healthcare Landscape and Access segments of the business• Foster deep customer relationships & collaboration within the account and OAPI assets to include: Sr. Leadership, Medical, HEOR and C&P• Help build compelling Brand Value Propositions that will resonate with our largest and most complex customers• Provide detailed Brand clinical information (approved reprints)• Share approved Health Economic Data and Models• Demonstrate experience to further customer engagement by providing insights/expertise in relevant Therapeutic Areas• Leverage and Champion core market access resources and sales planning tools• Serve as the Market Access point between OAPI and Internal/External Customers to include:• Enable robust account strategy development as part of the Market Access Strategy Planning Cycle as well as Senior level strategic planning,• Lead and bring customer insights into strategic discussions for the OAPI’s internal team while creating innovative and profitable contract proposal that enable portfolio access and exceptional GTN management• Serve as a role model while leading discussions on customer insights on behavioral trends, market conditions, and changes in formulary/medical policies• Provide exceptional leadership during MML/HEOR/Marketing team interactions with Customers to include unique MML engagements and relationship building with peers• Collaborate with Market Access Regional Account Managers/Sales Regional Business Director/District Business Managers/Manufacturer partners to optimize business performance and/or manage complex business risks and issues• Engage with Otsuka Government Affairs and Advocacy to help shape policy input and direction execution against opportunities and threats in area of responsibility• Ensure Account Management CRM tool are up to date with all account activities and Business Plans are robust and up to date• Review and correct Formulary information monthly via MMIT data• Conduct all activities in compliance with all applicable local, state and federal laws and regulations as well as company policies
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The Total Rewards function is seeking a Benefits Manager to collaborate with the Associate Director, Total Rewards and Total Rewards Analyst, to provide functional subject matter expertise in support of the design and delivery of the company’s Total Rewards & Benefits strategy. This position will support the administration of the company’s full suite of benefits offerings, including its health and welfare plans, retirement plans, and wellness programs. This position reports to the Associate Director, Total Rewards. Responsibilities:- Assist in the overall design, administration, delivery and support of the organization’s employee benefits programs and related procedures to ensure successful adoption and compliance with all applicable laws- Supervises the leave and disability administration process - Provides advice and guidance to Business Partners and employees on all issues related to FMLA, and other leaves of absence for medical, family and personal reasons in accordance with applicable state and federal regulations- Serve as benefits subject matter expert and liaison to the company’s vendors. Additionally, serve as an internal benefits consultant and educator to employees, People Team and Business Partners- Research competitive benefits trends and further refine Otsuka’s Total Rewards and Benefits philosophy- Serve as the lead point of contact for escalated employee inquiries, while developing ways to streamline operational processes and day-to-day inquiries- Assist in the development of impactful benefits-related HR Analytics, including ongoing reporting of dashboards and ad-hoc reports- Ensure benefits programs and processes are documented and compliant with People team strategies, policies and governmental regulations. Ensure benefits-related documentation, supporting materials and communications are thoroughly reviewed for accuracy, updated in a timely manner and compliant with respective plan or governmental regulations- Proactively collaborate with People Team and Business Partners in program delivery and other projects as assigned. Maintain clear understanding of the integration with other People and Finance workstreams (e.g. payroll, accounting, etc.) and the downward impact of benefits-related decisions and process changes- Effectively manage vendor and third-party administrator relationships- Continually evaluate existing benefits programs and processes; make recommendations for enhancements or improvements in support of strategic initiatives or as triggered by changes to available environments, regulation, technology or business needs- Plans, implements, and evaluates wellness programs; coordinates with key partners on programs, projects, and initiatives
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This is an Individual Contributer position, reporting to the Director/Associate Director of Device Development and Technology. This individual is the technical expert in the field of combination products & drug delivery devices who can effectively navigate and balance complex engineering, regulatory, quality and commercial needs while developing the best product for the user and patient. Primary expertise should be demonstrated in engineering, device regulatory, device quality systems (CFR 820, ISO 13485), human factors engineering principals, risk management for medical devices (ISO 14971), etc. The successful candidate should demonstrate strong technical writing and presentation skills and be able to translate technical information to non-technical audiences. This position requires 7 - 10 years of applicable experience in the pharmaceutical, biotechnology or medical device industries. The candidate will be responsible for the creation and management of design history files and technical dossiers for combination and device projects for new and existing products. Additional responsibilities include facilitation of risk assessments, coordination of human factors usability studies, creation and management of product and component specifications, design control documents, engineering protocols and reports and frequent presentations to project teams and management. This position will frequently require management of outside resources as well as assigned and/or unassigned leadership of project teams in a matrix organization. Technical Writing experience required. The position may involve frequent domestic and international travel up to 10% or as required by the project. Will manage indirect reports. Support the vision for the Device Development function- Support and implement a vision with appropriate strategies that supports the OPDC objectives and aligns with the business and OPCJ/OPDC/MDD development programs- Work with members of Device Development and Technology, and other functions including Packaging, Supply Chain, Clinical Supplies Operations, Quality Control, Regulatory and Quality Management to support strategies for product and process improvements - Support the development of flexible and compliant product development process.Develop and support the strategic activities of the department:- Support and implement appropriate filing strategies working with OPCJ, OPDC, MDD and OAPI departments to support registration of all new products and life-cycle management products.- Initiate and manage the development and implementation of policies, procedures, and standards for the Device Technology department. - Evaluate and recommend strategic directions for new and innovative delivery device technologies to support new and life-cycle management projects.Develop and perform the tactical activities:- Ensure efficient transfer of products and on-going product support all products to CMO’s from device perspective.- Develop and maintain departmental knowledge, experience, and expertise in state-of-the-art devices for pharmaceutical products.- Assure adherence to latest worldwide regulatory rules and guidance concerning devices and work to develop device risk mitigation.- Create, maintain and update device related documents required for regulatory filings and compliance - Facilitate studies as required.Program management of Device projects:- Develop project plans and corresponding project managements tools to support the execution of all projects- Manage cross functional teams (including 3rd party resources)- Execute Human Factors Engineering & Usability activities- Write protocols, reports, specifications, procedures, change control requests, technical assessments, etc
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To be a credible source of evidence based information that demonstrates the value of Otsuka products from the clinical, economic, and humanistic standpoint and works in partnership with providers, payers and other key stakeholders to apply practical real-world solutions to improve patient outcomes. Key Job Responsibilities:- Ensure appropriate dissemination of clinical information, knowledge and services in a timely, ethical, and customer-focused manner.- Keep abreast of the current literature, therapeutic issues, and competitive landscape related to psychiatric disorders.- Establish status as a knowledgeable and trustworthy medical and scientific resource for opinion leaders with expertise and knowledge of supported product(s), treatment trends, clinical trials, and scientific research.- Communicate current and emerging clinical research data to opinion leaders in response to unsolicited inquiries.- Identify medical experts to provide services as speakers, consultants, and investigators.- Engage national, regional and local payers, payer advisors and influencers that make patient access and reimbursement decisions.- Communicate cost effectiveness evidence that address payer needs and priorities; partner with providers and payers to put into practice decision support and care management tools and apply real-world evidence and solutions in the practice setting.- Deliver scientifically focused balanced and objective educational presentations to groups of strategic importance such as hospital and payer P&T committees.- Train speakers for promotional programs on product knowledge, clinical/scientific data, and information consistent with established company policies and compliance guidelines.- Participate and interact with opinion leaders, local practice leaders and other key stakeholders, including preparing moderators at national, regional and local conferences, advisory boards and other approved gatherings.- Gather scientific and competitive intelligence as well as customer insights during interactions with opinion and practice leaders or attendance of congresses and communicate to relevant Medical Affairs and Clinical Development personal.- Evaluate and assess potential investigational sites for participation in Otsuka-sponsored clinical studies as well as educate investigators about the study drug and pharmacovigilance procedures.
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This individual will report into the market access function, but work cross-functionally with sales, brand, trade, business analytics and commercial partners to drive strategic decisions and tactical programs that provide customer value for payers across therapeutic categories and over the lifecycle of products. The development of promotional and educational materials to support the field account executives, and other field personnel is a key deliverable for this function. This position will be responsible for building channel and brand payer strategies, collaborate on creating the value proposition and evidence generation strategy for US payers, segmenting payers, creating personal and non-personal tactics, managing the related budgets. Additionally, providing insight into pricing strategic plans will be a component of this position. The Assoc Director may also lead strategic market monitoring and expansion projects. The purpose will be to undercover insights that result in expansion, experiments and pilots that could expand business opportunities in these channels. The Assoc Director in this role must have hands-on payer marketing experience developing winning strategies that drive value and access in complex payer markets. This includes an in-depth-knowledge of payer customer environment, buy-and-bill systems, and an understanding of the evolving reimbursement landscape. They must have worked in a payer marketing role or had relevant experiences that demonstrate strategic thinking, driving results and customer orientation.7-10 years in the pharmaceutical industry with the majority of time in managed markets and marketing. • Understand and educate the organization on market access landscape, channels, and strategieso Develop Channel and Brand specific marketing strategies and associated tactics to support corporate and brand objectives and execution requirements thru all resourced Market Access Field teams.o Develop pull through strategies aligned to market access and brand objectiveso Direct Brand specific Market Access Market research activities.o Lead Market expansion opportunity projects• Lead cross functional market access strategy team to deliver an integrated market access strategy for the corporation while aligning to customer value with each engagemento Develop and maintain value message platform for Brand.o Direct and create the necessary promotional tools that support Account Executive efforts with key customers and pull through of payer opportunities in the field with customerso Manages key Agencies of Record to deliver tools and tactics• Lead budget planning process for Market Access and Manage Market Access Marketing Brand budget resources.• Engages and informs commercial partners.
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This position will be responsible for leading a Market Access field account management team. This includes overseeing customer facing account management functions for all required payer channels for OAPI brands. This position will have a key role in execution of Market Access strategy as well as ensuring profitable access and contract negotiations. This position will also lead the assessment, development of recommendations and plans and execution against the US Payer market in close collaboration with Field Sales. This applies specifically to National and Regional Payers, Integrated Delivery Networks, VADOD channel and State Medicaid entities. This position will also include strategic participation in preparation for all upcoming launches. The position will report to the Vice President Market Access and will manage a team of Account Executives. The position is field based and requires extensive travel. Key Job ResponsibilitiesDirect and oversee an account management teamServe as the key communication conduit for the account team on home office initiatives and as the key conduit for informing and advising management of key real-time issues and trends from the market access field Serve as the key negotiation strategist for business to business transactions between OAPI and Customer targetsAssist Headquarters team in assessing customer behavioral trends, market conditions, and changes in formulary/medical policy techniques that have immediate and longer-term implications for the businessOversee the development of Account Plans across all payer channelsRecommend the design of Incentive Compensation programs for the Account Management Function in collaboration with Sales Operations Incentive Compensation teamEnsure compliance with all OAPI policies and proceduresCollaborate with the Sales Regional Directors to optimize business performance and/or manage complex business risks and issuesRepresent OAPI to key Payer AssociationsParticipate in development of product and channel specific strategies including contracting and execution. Direct Account Management CRM tool and process in collaboration with Sales Operations staffConduct all activities in compliance with all applicable local, state and federal laws and regulations and company policiesStrategic role in looking at and leading a corporate approach to the emerging entities of Integrated delivery networks and IDNsWithin the new environment provide strategic planning and execution of the direction of the AE teamWork in collaboration with Market Access Marketing in the development of customer facing tools and deliverables
