-
The Senior Director, Regulatory Affairs provides regulatory expertise and support for pre-clinical, clinical, and commercial areas for investigational and marketed products. Ensures development of drugs are in accordance with global regulations in order to approve drugs quickly and smoothly within typical approval timeframes. Ensures marketed products are supported with minimal questions and issues from the regulatory agencies. Works with Regulatory Management to establish well-defined regulatory pathways and creates accurate and timely documents for IND and NDA submission and final approval. Additional responsibilities include but not limited to the following:- General regulatory experience supporting pre-clinical to clinical domains for investigational products- Candidate will have specific digital health experience & the ability to shape policy in this space- Desire to pioneer new regulatory strategies and pathways within the digital space- Candidate who will proactively drive new regulatory policies by developing a strong relationship with key leaders at FDA and forging a true partnership with regulators- Resource that can see the entire landscape and negotiate across constituents and may even be able to build bridges between CDER and CDRH- Candidate would work closely with Strategic Partners product team to evolve product strategy as they work with FDA to impact policy so that we are a step ahead to keep product relevant- Resource should proactively monitor the federal register, understand the FDA position, work with internal stakeholders to craft Otsuka position, liaise with Strategic Partner to understand their perspective and negotiate across all stakeholders to our desired outcome (Strategist that can 1) evaluate our probability of technical & regulatory success (PTRS) 2) identify gaps in our label and 3) build an executable strategy to address those gaps- Individual who can work alongside medical/population health leader to build evidence to support the value prop
-
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.
-
Otsuka is looking for a technically strong data scientists with expertise in machine learning, statistical data analytics, and applications. The prospective candidate must have an excellent knowledge of advanced methods, and experience in applying those methods to novel applications. The successful candidate will be enthusiastic open to grow in new directions in a pharmaceuticals setting covering a variety of functional areas, work with a team of scientists and practitioners from different functional areas to solve practical problems. Fresh graduates with advanced degrees are welcome to apply. Job Responsibilities- Establish and implement end to end proof of concept for data analyses across functional areas- Build proof of concept systems in collaboration with data engineers and scientists.- Develop new data driven and digital models to transform business operations- Presenting to senior leadership as well external audience- Demonstrates the ability to create new and different solutions that align to real work problems and opportunities- Proficiency in computer programming with excellent software development skills using state-of-the-art technologies and languages (C++, Java, R, Python, and other scripting languages)- Lead data science projects end-to-end from conception to Proof-Of-Concept to deployment- Establish strong collaborations with business units to understand data and advanced analytics needs across business functions and translate them to data science and engineering initiatives
-
The Senior Director, Talent Management will work closely with the entire HR team to design and deploy and overall only Otsuka Talent Strategy and set a new expectation for the enterprise to deliver end to end talent solutionsAreas of focus include and are not limited to: - Will work closely with the CHRO and Senior Business Partner/OE lead to build a solutions HR model and metrics for success- Rationalize and streamline strategic Talent spend and partnerships - Build and market and end to end talent lifecycle slate of offerings focused on executive, leadership, and management levels. - Co- create sales development offerings and rotational programs and tools- Develop a targeting executive development onboarding experience- Co-lead building the HR model of future with hear of people and HRBPs and HRIS etc.- Enable a shared services TM model that includes WD design and implementation with HRIS, LD, PM, TM, Succession- Build end to end only Otsuka talent strategy encompassing learning, leadership development, cultural immersion, onboarding, recruitment – hire to develop to retain and engage lifecycle- Build a true L&D arm with 3rd party support that is targeted and relevant - Build enterprise capabilities in OE, change- Dynamic Otsuka career maps and journeys for employees- Use of technology, data and metrics to drive predicative modeling and strategies for people, talent, org and recruitment; AI assessments and gamification incorporated to talent approaches; Data and insights for predictive talent modeling and workforce planning- Drive next gen succession planning - Board presentation and macro people analysis - Cultural and engagement surveys of future – real time - Consolidate and manage strategic third party relationships to ‘right size’ a competitive and strategic Otsuka Talent Office- Develop OD and change capabilities for enterprise, starting with HR team members- Enable a Talent Partner solutions model including consultation and annual program offerings with close collaboration across HR and the business Travel 15-30%
-
This individual will report into the Sr. Vice President, Business Development. He/ she will support Otsuka’s Business Development activities in the US focusing on pre-clinical and clinical stage business development opportunities. The Associate Director Business Development must possess substantial scientific knowledge and experience working in industry to understand the drug discovery and development process, and how scientific assessment within business development can advance our portfolio interests. The role requires extensive experience in the pharmaceutical industry, including a broad and deep understanding of development, regulatory and (ideally) commercial experience. This individual will participate in the process for identifying, prioritizing and sequencing of projects within pre-clinical / clinical stage business development, and gain BD experience through working within the broader US and global BD team. Ensure initiatives are in alignment with corporate strategy objectives. Acts as a communication conduit for business project status, actions, decisions, risk and issues and schedules for assigned projects.• Support search and evaluation efforts in the Neuroscience and Renal fields to proactively identify and solicit new strategic research partnerships with biotech and pharmaceutical companies, academic institutions, non-profit research or patient organizations • Work closely with relevant internal R&D teams to deeply understand their scientific strategy and align outreach strategy with existing and new areas of Otsuka’s R&D focus to align on opportunity assessment• Participate and eventually lead in-depth reviews and due diligence on external opportunities and act as a point of contact between the alliance teams and committees to assure successful collaboration with respect to development and commercialization of product• Coordinate the activities/input necessary to establish the business case (scientific/ technical evaluation, development plan, market research, market opportunity, competitive intelligence, strategic assessment, appropriate transaction financial structure etc.) • Maintains a therapeutic understanding and competence in area of focus to understand business, science and operations to lead to viable opportunities.• Perform initial scientific evaluation of external opportunities across all stages of development and play an integral role in the transaction team supporting licensing deals and/or acquisitions of assets
-
The Instructional Designer, Sales Training Operations will work with Sales Training Managers to design and develop onsite, online and mobile learning solutions delivered to the Otsuka Sales division. S/he will be responsible for designing, developing, reviewing, and revising training content using a variety of media development tools. This position will require application of instructional design theory and methods and use of learning technology to create a variety of learning solutions that improve business results.Key Responsibilities- Perform needs analysis and develop requirements for specific training interventions.- Utilize instructional design principles and models to manage the course development process for new and existing training content.- Lead the design and development of training products and initiatives, including product launch training programs, training on disease state, selling and business management skills ensuring an integrated approach with the clinical and the sales management curricula.- Effectively establish and sustain relationships with subject matter experts to solicit content.- Ensure ongoing analysis of basic and advanced training needs based on current and future requirements of the business and the changing internal/external environment.- Assist Sales Training Operations leadership with evaluating the effectiveness of the training initiatives and developing recommendations for training improvements.- Manage training vendors and provide quality control of the vendor-developed training products.- Research, evaluate, recommend, and implement new instructional technologies, innovative instructional practices, and new course delivery methods.- Manage Media Lab.
-
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
-
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
-
Otsuka is seeking an Associate Director, Global Clinical Development based in our Princeton, NJ offices, who will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP). The incumbent will be responsible for the evaluation and clinical development of CNS products at different stages of development for a global health-care market. The specific duties assigned to the Associate Director, Global Clinical Development include the following:- Consults with patients or their representatives, clinical, regulatory and scientific leaders and thoughtfully applies their recommendations toward optimizing trial objectives, designs and protocols.- Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other research project team members, and to external regulatory agencies.- Authors program strategies (i.e., GDCP) and oversees trials essential for determining the clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates.- Interprets and communicates results of Phase I-IV investigations in preparation for a new drug.- Acts as the signatory on NDA submissions and clinical study and safety documents.- Involved in product life cycle management from the earliest stages of development, constantly seeking innovations to add value strategically.- Provides strategic oversight in our vendor and CRO relationships, and provides clinical input into their governance committees.- Will help lead and support regulatory filing activities and documents. Providing strategic direction and editing to provide concise, clear and convincing argumentation in all such written and verbal communications.Job Expectations- Dedication to assigned, developed projects and project goals. This includes an appreciation of the principles applied in setting and achieving corporate goals through matrixed teamwork in a compliant, regulated business setting.- Willingness to travel 30% of time, over weekends and ability to travel internationally.
-
Serves as a member of the CMBO (Clinical Management and Business Operations) Leadership Team and leads special projects / task forces for OPDC. Establishes a portfolio approach to the management of Corporate Projects in alignment with strategic plans established by executive leadership.- Understands and applies business strategy to projects related to pharmaceutical development operations and commercialization plans.- Translates corporate project strategy into operational plans and objectives.- Leads (or co-leads) special corporate project initiatives and task forces as assigned.- Facilitates the review of corporate initiatives, makes recommendations for action, and ensures appropriate follow-up so as to achieve desired corporate project outcomes.- Anticipates, identifies, escalates and/or resolves corporate project issues and applies learnings across the portfolio.- Clearly communicates the vision, status, issues/mitigation plans and outcomes of corporate project initiatives to senior management.- Develops and maintains stable long-term relationships in both the internal and affiliated organizations. Fosters positive interactions that ultimately support achievement of the desired corporate outcomes.- Directly manages Corporate Projects staff and works seamlessly in a matrix environment with others assigned to corporate project initiatives.- Supervises, trains, coaches, and develops staff to achieve results. Accomplishes results through subordinates/technical professionals in a matrix environment.- Serves as a member of the CMBO Leadership Team. Effectively interacts and proactively works with senior management and CMBO personnel to advise, negotiate, and influence their actions and/or decisions regarding corporate initiatives.- Establishes and maintains a portfolio approach to the management of Corporate Projects across the organization.- Maintains awareness of project management methods, trends and best practices that are applied to corporate projects.- Establishes practices that affect the department. Manages the development, standardization, implementation, and maintenance of tools/ templates utilized by the department and liaises with other departments as needed to support these activities and to drive continuous improvement.
-
This position is responsible for the stewardship and analysis of customer master data with a strong emphasis on ensuring data integrity in accordance with commercial data governance practices and guidelines. This position also manages day-to-day data stewardship operations and provides leadership, coordination and guidance to onshore and offshore Data Stewards.Reporting to the Director of Sales Analytics & Automation, this position is responsible for the quality, consistency, integrity, compliance, accessibility and distribution of commercial customer master data and is accountable for business processes associated with the management of the data and related data repositories and systems. This role is critical to implementing a mature capability to drive fact based, actionable decision making by enabling a leading data management practice in support of commercial functions and processes including customer relationship management, targeting & alignment, incentives & compensation and business analytics.The position requires a pharmaceutical commercial data management expert who possesses high business acumen, understands pharmaceutical commercial operations, commercial business processes associated with customer master data management and commercial customer data sources and practices. In addition, the position also requires the ability to interact with a variety of internal departments including field sales, sales operations, brand marketing, commercial analytics, Information technology, legal & compliance, co-promotion partners, as well as outside data and service providers across the matrix.• Leads customer data stewardship operations and serves as a member if the Information governance operational committee as customer master SME. Maintains stringent data control process, policies, procedures and measures to ensure the quality, integrity, consistency, compliance, accessibility and delivery of commercial data disseminated from Sales Operations.• Manages day-to-day data stewardship operations including customer profile adjudication, change request adjudication, help desk escalations, field data inquiries and data quality reviews. Provides leadership, coordination and guidance to onshore & offshore data stewards to ensure that business requests and issues are addressed/resolved in an effective and timely manner.• Responsible for ownership and management of Customer Master data content, data lifecycles, business rules, and underlying functional processes. Leads the process of identifying and managing changes to customer data business rules. Provides input and guidance on enterprise data architecture initiatives to ensure data entities and elements are designed according to Otsuka’s data standards.• Defines creates and delivers master data quality metrics, data stewardship metrics and status to stakeholders. Monitors key metrics and statistics regarding the business content and integrity of customer master data. Performs periodic audits on the customer data infrastructure and data models for core commercial data repositories. Leads data impact analyses and provide guidance to downstream system owners on data utilization and analyses results.• Plans, executes and evaluates customer master data related change management activities including communications and training. Allocates and manages change management resources, prepares training materials and data for Master Data Management (MDM) related training, maintains MDM documentation and user manuals. Authors’ communications for enhancements, changes, best practices and FAQ’s. Engages downstream channel owners to understand usage of customer data and get buy-in on customer master data accountability and usage.• Works commercial functional areas and IT on identifying opportunities to derive more business value from customer master information and partners with key stakeholders to continuously monitor the utilization and value of customer data and its effectiveness in support of information governance and customer relationship management activities.• Supports the administration and maintenance of MDM and DW systems and partners with IT/Vendors on the analysis, design and implementation of new data management applications, enhancements, feature releases and special customer data management projects.• Supports Project Management (PM) and Program management office (PMO) efforts across Sales Operations projects and initiatives to ensure completion on time and within budget. Assist with the long-range planning and implementation of field force business solutions and systems.• Supports system integration testing (SIT) and leads user acceptance testing (UAT) for MDM, DW, CRM and BI projects including authoring testing plans and test scripts, tracking testing results, defining tollgates and testing closure.• Supports business process management and optimization efforts and defines metrics and monitor Sales Operations department performance against productivity targets (e.g. quality of work products, cycle times, project & program execution, etc.).
-
Responsibilities include but not limited to the following:Participates in all activities associated with forwarding Otsuka’s leadership in the identification, development and commercialization of innovative, safe and effective products for the improvement of mental health and the more effective use and access to healthcare diagnostics and therapeutics. Assists with the public dissemination of information and data, including product labeling and promotional materials.Provides support to the Vice President, Psychiatry and Behavioral Sciences by the following: - Develops, produces, and organizes manuscripts, presentations, international symposiums, and posters.- Interacts with experts in the field to obtain feedback on products- Provides input into the creation of marketing materials and ensures data is accurately and effectively communicated.- Provides input into regulatory documents.- Provides support and expertise to the commercialization teams- Provides input on feasibility of the product during pre-clinical and clinical studies.- Proactively acts as a liaison between the commercial group and the clinical development organization.- Participates in the evaluation of potential licensing and acquisition candidates.**Please note that although position is remote, ideally need candidate local to NJ or NY area.
-
The Director of Market Research role for CNS (Central Nervous System diseases) is a leadership position designed to support the customer & market information/insights needs of the US CNS Brand Teams. The position is responsible for leading the market research, competitive intelligence, and select business analytics for Otsuka America Pharmaceuticals Incorporated (OAPI) and reports into the Senior Director of Business Analytics & Insights. The CNS MR Director will lead the market research for one or more CNS inline brands and for CNS assets in early development (Clinical Trial Phases 1-3). The Director of Market Research is expected to function as a team leader and contributor to the design and implementation of actionable market research that drives brand performance and influences business decisions that add value. The primary stakeholder for the CNS MR Director is the OAPI CNS Business Unit.The CNS MR Director is expected to lead the design, execution, and/or management of market research projects. Additionally, the Director is expected to select, manage, and communicate with MR agency partners for primary and secondary market research projects in the US market (and international markets, as needed). The position also requires competency in business analytics and competitive intelligence, as well as leadership and collaboration with marketing and sales partners. The CNS MR Director is part of the Business Analytics & Insights organization which is one of several functions in the Commercial Operations Department. The CNS MR Director will interact with OAPI senior management and will serve as the primary MR point person for the assigned brands/assets.Knowledge and Skills Required:• Autonomous and entrepreneurial approach to leading MR projects and teams• Demonstrated excellence in executing MR projects, managing agency partners and leading teams• Broad and deep knowledge of both qualitative and quantitative MR tools and techniques• Demonstrated competency in going beyond market research results and providing deep customer insights that drive business success• Proven track record of applying cutting-edge market research tools and techniques to positively influence business decision making and brand performance• Demonstrated experience and expertise integrating primary and secondary data into synthesized information and insights• Unwavering commitment to teamwork and collaboration within and across functions• Proactively takes ownership of building internal relationships with colleagues and mastering cultural standards• Exceptional interpersonal and communication skills, including active listening• Demonstrated ability to collaborate effectively with marketing/sales partners and to influence decision making• Experience and confidence working with, challenging and influencing senior management• Adept at working in a dynamic and fast-paced environment• Strong analytical skills and insights generation expertise• Knowledge of and experience working with secondary data, including prescription data, patient-level data, sales data, and payer data• Ability to think creatively and innovatively in solving complex business problems and to apply solutions to drive actionable results.• Represent the MR function and associated interests in various business meetings and forums• Proven knowledge of the clinical development process and product life-cycle from early stage through product launch, maturity and loss of exclusivity.• Affinity for scientific information as well as working knowledge of medical terminology• Knowledge of and experience managing international market research programs• Experience selecting, managing and developing MR agencies to become trusted business partners; to provide exceptional insights; and to communicate clear and cogent stories that drive business value
-
An experienced pharmaceutical professional responsible for the oversight of strategic Technical Operations initiatives and projects . The successful candidate will serve as the project manager for multiple, complex global projects. This position requires the experience, knowledge, and maturity to think and act globally and locally, in partnership with executive management on organizational issues and projects.Identifies strategic Technical Operation organizational projects in conjunction with Technical Operations Leadership Team and leads multi-functional teams to implement from initiation through successful completion. Job Responsibilities:- Independently leads integrated and complex program teams to deliver on product development, manufacturing, supply chain and other technical initiatives. - Acts as a central point of communication for project/program related risks, issues, action, decisions, and plans.- Assumes the primary role in project management by ensuring an effective governance process with cross-functional teams and successful execution of projects.- Actively engages in strategic planning activities and translates decisions into operational plans. Ensures that communications between the team, functional management and/or senior management are handled in an efficient, effective and timely fashion to ensure a proactive management environment.25%-50% travel required
-
Within Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) exists the Global Clinical Development (GCD) department. - OPDC-GCD are a group of physicians and scientists who lead clinical development activities for Otsuka’s global health-care products. Our team is collaborative, innovative with a mantra of “acting as though the company was our own.”- Our responsibilities range from due-diligence evaluations, where we stress-test others’ development plans, to development and implementation of our own global development & commercialization plans (GDCP). The GDCP translates basic research and preclinical pharmacology & toxicology into a streamlined plan for first in man, proof of mechanism, registrational and post-approval trials. Its goal is to efficiently evaluate the product’s potential and probability of success, support an effective commercial launch and plan for meaningful innovations to improve or expand the value of the initial product for our global customers (patients, prescribers and payors).Detailed Description of Duties:Otsuka is seeking a Senior Director, Global Clinical Development based in our Princeton, NJ offices, who will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP). The incumbent will be responsible for the evaluation and clinical development of CNS products at different stages of development for a global health-care market.The specific duties assigned to the Senior Director, Global Clinical Development include the following:- Consults with patients or their representatives, clinical, regulatory and scientific leaders and thoughtfully applies their recommendations toward optimizing trial objectives, designs and protocols.- Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other research project team members, and to external regulatory agencies.- Authors program strategies (i.e., GDCP) (Global Development and Commercialization Plan) and oversees trials essential for determining the clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates. - Interprets and communicates results of Phase I-IV investigations in preparation for a new drug.- Acts as the signatory on NDA submissions and clinical study and safety documents.- Involved in product life cycle management from the earliest stages of development, constantly seeking innovations to add value strategically.- Provides strategic oversight in our vendor and CRO relationships, and provides clinical input into their governance committees.- Will help lead and support regulatory filing activities and documents. Providing strategic direction and editing to provide concise, clear and convincing argumentation in all such written and verbal communications.
-
The Director, Market Access CNS reports to the VP, Market Access . The position leads the development and of portfolio approaches to our market access customers, corporate approach recommendations to existing and emerging channels, bridging early development product market access strategies to inline and is accountable for all brand payer related initiatives for the CNS portfolio and works closely with the CNS brand teams. Key Job Responsibilities- Develop and lead a cross CNS portfolio approach to market access customers- Develop an CNS wide portfolio value proposition for market access customers - Lead the team to develop and implement payer pull-through material- Lead the team to develop and refine the payer value proposition for each inline brand- Collaborate with Commercial team to ensure payer value drivers are incorporated into all payer marketing initiatives- Continually evaluate Market Access strategies for early development by partnering with Medical Affairs, Health Outcomes and the Market Access team while effectively bridging them to inline marketing support- Lead the Development and maintenance of the value message platform for each CNS Brand- Direct Brand specific Payer/Advocacy Market research activities- Manage Payer Marketing Brand budget resources- Lead market access channel assessments and build recommendations on the best way to approach our existing channels- Lead the assessment and development of new channel enhancement- Manages key Agencies of Record to deliver tools and tactics- Engages and informs partners- Collaborates closely with CNS brand teams
-
The Project Coordinator, Medical Affairs Operations and Research under direction of the Assoc. Director Medical Affairs Operations and Grants office is responsible for supporting the Medical Affairs team in the planning, execution, and close-out of a variety of strategic and tactical projects. Primary responsibilities will include, but are not limited to, facilitating compliant investigator-sponsored study (ISS) and grant processes within the Medical Affairs management system, supporting global expansion of the Medical Affairs management system, coordinating departmental budget & forecast activities, and playing key role in operational process improvement across the department.- Coordinates project information across Medical Affairs and is responsible for developing and maintaining good relationships with other functions such that it will foster positive interactions and ultimately support achieving desired project outcomes.- Supports activities within the Medical Affairs management system through planning, executing, documenting, monitoring and communicating projects including status updates, payments, course corrections, timelines, milestones, and program metrics. - Supports Medical Affairs quarterly forecasts, manages scope, timeline and financial changes through tracking variances at the program level by cross-functional interaction with medical teams- Facilitates vendor, payment and contract set-up in preparation for project initiation - Supports Medical Affairs global projects and directives to align processes and increase efficiencies across affiliate companies in order to better the business. - Responsible for ensuring timely, accurate and comprehensive project and program information is available to senior management and the wider global organization.- Ensures project management tools and metrics are used appropriately to enhance project and program delivery and information dissemination to the business.- Collaborates with all functions including administrative, clinical, finance, legal, government affairs, medical, operations, EQC, and regulatory – to lead as appropriate and support Medical Affairs projects.Travel esimate: 10%
-
The Market Research Manager role supporting the Central Nervous System (CNS) businesses at Otsuka Pharmaceuticals supports the commercial insights needs for inline brands and early development assets. The MR Manager will be responsible for market research, competitive intelligence and other commercial research for Otsuka’s portfolio of brands and assets indicated to treat patients living with psychiatric conditions. The role will support one or more CNS brands and Life Cycle Management (LCM) opportunities. The role reports to the Market Research Director for CNS and will work day-to-day with the CNS team. The Manager is expected to conduct insightful and actionable market research that will have a positive impact on brand performance and inform decision making for marketing and sales. Key stakeholders for the CNS MR Manager include the CNS Brand Team and Commercial Operations.The MR Manager is responsible for the design, execution, and management of market research projects. In addition, the MR Manager is expected to commission and partner with MR agencies for primary and secondary research in the US and international markets, as needed. The position requires proficiency in business analytics as well as leadership and collaboration with marketing and sales partners. The person in this position will be part of the Business Analytics & Insights organization and work directly with the CNS brand team. Knowledge and Skills Requirements:• Self-starter that will proactively take ownership of building internal relationships and learning the Otsuka culture• Comfortable working in a dynamic and fast-paced environment• Proven track record of applying market research insights to positively influence brand performance• Oversee and deliver qualitative and quantitative primary market research• Experience working with secondary market research data, including prescription data, patient-level data, sales data, and payer data• Proven experience and expertise integrating primary and secondary data into synthesized information and insights• Ability to develop and leverage new market research tools and process to drive deeper insights• Lead special projects as required by the needs of the business• Represent the function in various business meetings• Proven knowledge of the clinical development process and product life-cycle from early stage through product launch, maturity and loss of exclusivity.• Affinity for scientific information, as well as working knowledge of medical terminology• Knowledge in managing international market research projects• Strong, game-changing analytical abilities and insights generation skills• Strong interpersonal and communication skills• Ability to collaborate with marketing/sales partners and to influence decision making• Experience managing and developing vendor relations so that the agency can best contribute to Otsuka’s future success• Strong team player with good leadership skills
-
Responsible for developing the Quality Management System (QMS) strategy, policies, processes, standards and systems for Otsuka and its affiliates. Manage, implement, and maintain quality management system. Develop and sustain the Quality Management System in line with the required industry standards. Regulate, control and improve the quality of all processes throughout the business and the final product. Embed a culture of continuous improvement throughout the company. Lead the team to achieve quality management system objectives to ensure compliance excellence and achievement of business goals. Strategy and Development- Contribute to the creation and implementation of best practice capacity planning vision, strategy, policies, processes and procedures to aid and improve operational performance- Contribute to new business initiatives and projects and review and communicate the impact on Quality Management System (QMS)General and Task Management- Develop the Quality Management System strategy and the management arrangements for key milestones, demonstrating solid progress against plan- Implement all relevant procedures described in the Quality Management System (QMS)- Ensure that all in-house systems and procedures are updated, revised and modified to meet the needs of external regulatory authorities- Ensure compliance with all regulatory requirements through the maintenance and improvements of the Quality System and organizational effectiveness- Update quality documentation and communicate to carry forward lessons learned from quality concerns- Ensure that all necessary systems and procedures are in place to satisfy all requirements, audits and inspections- Monitor processes for effectiveness and identify gaps for continuous improvement efforts- Train others in all aspects of the quality system and application of procedures- Undertake and assist with regular internal and process audits of the QMS- Ensure corrective actions are undertaken to address non-conformities- Verify closure of non-conformities- Provide detailed analysis of noncompliance- Ensure ongoing compliance with the Quality Management System- Support any global organizational initiatives such as harmonization of standards and best practices- Attend various meetings and action/communicate instructions- Produce written reports and make presentations- Undertake continuous training and development- Identify business improvement opportunities within the organization- Develop, implement and manage key performance indicators (KPIs) for each area of responsibility- Set department objectives/KPIs and review and assess ongoing performance of direct reports- Ensure KPIs are met by working to the overall plan- Report on achievement of objectives and timelines and identify any actions required- Conduct risk assessments of processes and tasks in the departmentPeople Management- Manage, coach and develop a high performing Quality System team- Drives agreed objectives and delivers best practice results, added value and continuous improvements- Manage and lead the team, ensuring adequate progress of group initiatives- Motivate and coach the team to operational success- Monitor the completion of tasks and ensure good performance and record on appropriate systems- Consistently promote high standards through personal example and roll out through the team so that each member of the team understands the standards and behaviours expected of them- Review, implement and update company records e.g. training matrices, performance reviews, risk assessments- Communicate KPIs so that each employee is aware- Provide technical expertise to the teamRelationship Management- Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance- Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy- Liaise and communicate with other functional areas- Provide a strong detailed quality focus as well as managing all work affecting quality- Work as part of the Management team to share ideas and improve operation, recommending, supporting and implementing continuous improvement activities and process and procedure improvements to optimize results and improve quality of delivery in line with quality standards requirements
-
The Associate Director, Integrated Pharmacy Network Operations is responsible for developing and implementing a best-in-class operational model to support an Integrated Pharmacy Network for select OAPI products. The Integrated Pharmacy Network is a partnership with select retail/specialty pharmacies that provide patient and provider services to ensure access to Otsuka’s products. This position reports to the Director, Trade and Specialty ChannelsResponsibilities:• Develop and implement operational structure to support integrated pharmacy network model, and continuously monitor performance to ensure objectives are met• Responsible for leading the OAPI relationship with all third-party service vendors (requirement setting, sourcing and contracting, ongoing performance management)• Identify appropriate metrics and tracking to ensure the right execution and success; analyze procedure volume and trends• Attend Quarterly Business Reviews (QBR’s) with pharmacy customers and communicate expectations• Assist with the implementation of new services, program enhancements and operational efficiencies• Maintain program correspondence, scripting, and collateral via internal legal and regulatory approval processes• Partner with internal operations and data analytics teams to continuously evaluate and analyze pharmacy network performance relative to goals and objectives• Present pharmacy network metrics to senior leadership on a regular basis• Continual development and management of Channel Operations personnel• Develop and communicate key messages to internal and external channel partners• Ensure the highest level of ethics, quality, and compliance by demonstrating in depth knowledge of laws that govern channel and access related work• Ensure compliance with all OAPI policies and procedures• Conducts all activities in compliance with all applicable federal, state and local laws and regulations and company policies
