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We are a company that believes in performance excellence, which is based on a framework of Performance, Leadership, and Continuous Improvement. We will accelerate our sales growth through the leadership and development of our people to outperform the competition. Position Summary:The Renal Account Manager contributes to OAPI’s overall sales objective by performing assigned sales related activities. Provides hospitals, physicians, pharmacists and healthcare providers with products, services, and information that will enable them to use and prescribe OAPI products safely and effectively.We are looking for individuals who are highly motivated, learning agile, and can grow in a Commercial organization.Otsuka-people who:- Think differently by challenging conventional thinking- Are intellectually curious and life-long learners- Are effective, ’get it done’ and have a sense of ownership- Are comfortable with ambiguity, autonomy and recognize that innovation is at its best when people connect- Are remarkable in their chosen fieldKey Job Expectations/Responsibilities:- Ensures full compliance with drug laws, regulations, and OAPI policies in all aspects of interactions with healthcare professionals- Achieves the assigned sales objective for the territoryEffectively manages the formulary process to ensure product acceptance to assigned hospital accounts by establishing credibility with key hospital stakeholders, performing timely formulary review for products, expediting formulary acceptance of product, implementing effective plans for product pull-through, and organizing in-services to communicate appropriate approved product information to appropriate hospital personnel on all shifts- Attains the designated goals for calls on appropriate accounts and healthcare professionals- Communicates balanced, accurate, and complete information on OAPI products- Executes calls on pharmacists in order to provide product information and to ensure the availability of OAPI products in assigned accounts within the territory- Collaborates with market access team for formularies and product availability- Demonstrates consistent completion of all administrative requirements in a timely manner, including call reporting, budget management, log-ins, etc.- Completes all required training courses and continually updates product knowledge- Assists district manager in training new Renal l account managersCompliance Management:- Ensures full and complete compliance of all selling activities within the area of responsibility to OAPI standards and to all state and federal regulations- Complies with the letter and spirit of all state and federal laws, regulations, and guidance as well as PhRMA Code on Interactions with Healthcare Professionals and OAPI standards and policies relating to all promotional activities
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The Senior Manager, Training and Development, collaborates and communicates closely with the senior leaders in the Training and Development Department to develop and drive achievement of department objectives and responsibilities. Coordinates closely with their peer Senior Training Managers and Associate Director of Training and Development Operations to ensure that learning needs are identified, training programs are developed and learning experiences are implemented which strengthen the capabilities of a specialized Field Sales Force. Works cross functionally with Brand teams, Field Sales Leadership, Medical and other internal key stakeholders to ensure Training and Development programs/deliverables are in alignment with brand/company strategies and support achievement of objectives. The Senior Manager is responsible for managing and coaching the Training Managers to ensure the development and delivery of training programs necessary to enhance the functional and technical skills of the Field Sales Force. In this role, the Senior Manager works with the Training Manager team to oversee the development and delivery of training programs including concept design, materials development and implementation. The leader in this role must leverage best practices across the department and assist the Training Managers in identifying existing course content and multi-media delivery channels to enhance the impact of the training. Continually assesses the training and developmental needs to maintain the high quality and effectiveness of the sales force. Constantly evaluates the effectiveness of the training programs. The Senior Manager is responsible for the coaching and development of the Training Managers that report to him/her. This includes development of Training and Development competencies and skills, with support of the Training and Development Operations Team, as well development of leadership competencies and skills. • Collaborates and communicates with peer Senior Leaders in Training and Development Department to achieve department objectives• Works cross functionally with key internal stakeholders to develop training programs that support achievement of company/brand objectives• Coaches, develops and manages assigned Training Managers• Oversees the Training Managers’ design, development, and implementation of the Field Sales Representative training programs in a variety of formats• Supports the Training Managers in assessing the effectiveness of the training and creation of follow-up programs for continuation of specialist development• Supports the Training Managers in surveying vendor training resources, evaluating resources, and recommending outside vendor training resources/programs as necessary.• Works with co-promotion partner(s) and Training Managers to develop mutually beneficial training programs• Ability to adapt, work through conflicts, and persuasively influence outcomes• Able to lead and manage in a fast-paced business environment• Able to effectively manage Brand/Training and Development budgets, leverage resources in formal and informal reporting structures• In conjunction with Training and Development Operations, collects and analyzes performance data for program participants and uses results to make recommendations to senior leadersLeads the Training Managers in the development and implementation of strategic training plans for new product launches.
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We are a company that believes in performance excellence, which is based on a framework of Performance, Leadership, and Continuous Improvement. We will accelerate our sales growth through the leadership and development of our people to outperform the competition. Position Summary:The Renal Account Manager contributes to OAPI’s overall sales objective by performing assigned sales related activities. Provides hospitals, physicians, pharmacists and healthcare providers with products, services, and information that will enable them to use and prescribe OAPI products safely and effectively.We are looking for individuals who are highly motivated, learning agile, and can grow in a Commercial organization.Otsuka-people who:- Think differently by challenging conventional thinking- Are intellectually curious and life-long learners- Are effective, ’get it done’ and have a sense of ownership- Are comfortable with ambiguity, autonomy and recognize that innovation is at its best when people connect- Are remarkable in their chosen fieldKey Job Expectations/Responsibilities:- Ensures full compliance with drug laws, regulations, and OAPI policies in all aspects of interactions with healthcare professionals- Achieves the assigned sales objective for the territoryEffectively manages the formulary process to ensure product acceptance to assigned hospital accounts by establishing credibility with key hospital stakeholders, performing timely formulary review for products, expediting formulary acceptance of product, implementing effective plans for product pull-through, and organizing in-services to communicate appropriate approved product information to appropriate hospital personnel on all shifts- Attains the designated goals for calls on appropriate accounts and healthcare professionals- Communicates balanced, accurate, and complete information on OAPI products- Executes calls on pharmacists in order to provide product information and to ensure the availability of OAPI products in assigned accounts within the territory- Collaborates with market access team for formularies and product availability- Demonstrates consistent completion of all administrative requirements in a timely manner, including call reporting, budget management, log-ins, etc.- Completes all required training courses and continually updates product knowledge- Assists district manager in training new Renal l account managersCompliance Management:- Ensures full and complete compliance of all selling activities within the area of responsibility to OAPI standards and to all state and federal regulations- Complies with the letter and spirit of all state and federal laws, regulations, and guidance as well as PhRMA Code on Interactions with Healthcare Professionals and OAPI standards and policies relating to all promotional activities
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The District Sales Manager is advanced in their demonstration of sales and leadership proficiencies. They are active participants in recruiting, hiring, training and development of Account Managers to meet and exceed sales goals and other sales-related objectives.The successful Manager will lead their teams in the accomplishment of these objectives through coaching and feedback, enabling them to increase the market share of the company's products. This leader is fully self-sufficient and able to apply skills successfully in all situations.Knowledge, Skills, Competencies, Education, and Experience:Business Plan Development and Execution:- Attains the assigned sales objectives for the District and ensure achievement of designated goals for sales calls. Through the development of a local customized plan that meets the needs of the unique district market while staying aligned to organizational priorities.- Ensures effective execution of the tactical and operational segments of the sales plans for all marketed products by the District’s representative staff.- Actively participates in evaluation and refining of promotional strategies, business plans, and sales forecastsPeople Development:- Execute District plans for deployment, including recruiting, hiring, training and development of Account Managers- Provide on-going coaching through a consistent framework that allows for mutual identification of performance opportunities and dynamic action plans including follow up that measures progress towards agreed upon goals and expectations of competency- Demonstrate flexible approach, employs distance coaching to increase quality coaching touch point frequency- Develop Account Manager talent pool for higher levels of responsibility or deepen expertise and proficiency in their chosen therapeutic area- Differentiate performance, provide feedback, and proactively address performance issues- Plan and facilitate district meetings and participates in training, POA, and national meetings as requiredBudget Management:- Develops operating budgets for District’s assigned representatives, operates District in assigned expense budget- Monitors individual operating budgets and ensures team operates within budget- Works with internal partners to validate market trends and develop plans and tactics- Purposeful and ongoing collaboration to ensure successful execution and pull through of local tacticsInternal / External Partnerships:- Coordinates the deployment of personnel and resources in an effort to maximize opportunities- Coordinates with alliance partner sales management team within district geography on development and execution of sales plans- Coordinates staffing of exhibits and connections occurring within the area of responsibilityCustomer Management:- Manages key account coordination along with the Account Manager to develop relationships leading to increased profitability and better patient outcomes- Represents OAPI before selected customers (e.g. key customer’s and customer groups)- Utilizes local opinion leader relationships to stay current on dynamics and emerging influences that may impact Otsuka product portfolioCompliance 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 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 promotional activities- Identification of risks and issues associated with non-compliance and implications of regulatory infractions
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This individual will report into the Sr. Vice President, Business Development. He/ she will provide Business Development leadership focusing on clinical stage business development opportunities. The Sr. Dir. Business Development must possess substantial and extensive scientific knowledge and experience working with compounds and development. In addition, the role requires extensive experience in the pharmaceutical industry, including a broad and deep understanding of development, regulatory and commercial. This individual will lead the process for identifying, prioritizing and sequencings of projects within clinical stage business development. 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. Lead various corporate initiatives as needed. Knowledge:• Business development experience specifically within clinical stage business development• Requires demonstrated knowledge and understanding of pharmaceutical development and commercialization and business practices required to successfully bring drugs to market and launch drug product• Knowledge of regulated environments• In-depth knowledge of enterprise portfolio management and strategy• Extensive scientific knowledgeSkills:• Self-starter who is able to effectively lead multiple projects simultaneously • Deliver and produce outcomes consistently over time• Strong negotiator and collaborator who strengthens business relationships• Effective creator and presenter of executive and functional information• Strong business acumen and analytic and quantitative skills • Utilizes experience, presentation and influencing skills to facilitate successful acquisition of the right opportunities • Demonstrates team and resource management skills; including the ability to manage team dynamics across companies.• Deep knowledge of Behavioral Healthcare at the state and local level• Knowledge of behavioral payor organizations and trade associations• Knowledge of organization and funding by state, state laws, agencies and accrediting bodies especially Medicaid and MH/SA• Ability to influence and lead cross-functional teams. Competencies:• Consistently demonstrates competencies at the Senior Leader level: Strategic Agility, Learning Agility, Building Effective Teams, Developing Directs/ Others, Decision Quality, Dealing with Ambiguity, Managerial Courage, Managing Vision/Purpose
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Provides global regulatory intelligence expertise to regulatory affairs, pre-clinical, clinical, and commercial areas for investigational and marketed products. Ensures that regulatory/competitive intelligence, or scientific/regulatory information searching, summarization, assessment and dissemination are provided to the Otsuka organization.Proactively monitors emerging external scientific and regulatory trends, approvals, and strategies to inform and influence the development of regulatory strategies and policies both across and within disease therapy areas. Works with Global Regulatory Management to provide both routine and ad hoc requested information including implementing a commenting process on health authority guidance and directives.Leads development of Policy or Position Papers. - Under the direction of the Senior Director Global Regulatory Affairs, provides strategic regulatory intelligence using both routine reports and as well as targeted information to support both project and organizational activities.- Designs programs for complete and accurate IND/CTA/NDA submissions and ensures that clinical trials are designed to meet regulatory requirements.- Takes independent and creative actions to determine solutions to meet the known and anticipated needs for the organization at both the product and organizational levels.- Independently compiles regulatory and competitive intelligence and ensures good channels of communication are established for this information.- Interacts with providers of regulatory and competitive intelligence to ensure high quality sources of information.- Identifies and oversees outsourced suppliers of regulatory intelligence and assessments in the preparation and documents/reports.- Work closely with IRC as search and information resource.- Develops and implements a health authority guidance and directive commenting process.- In collaboration with Regulatory leadership, develops and implements regulatory information tools and reporting methods.- Investigates and analyzes the regulatory precedence for Health Authority approvals for competitive products.- Identifies the development programs used to support competitors' license applications and the issues raised during the review process, including scientific advice and results of FDA Advisory Committee meetings.- Prepares and delivers regulatory intelligence newsletters on agreed schedule highlighting pertinent regulatory activities and potential impact on Otsuka Business and products.- Supports Regulatory Policy initiatives through the delivery of research and analysis.- Works with other functional areas including Technical Operations, Supply Chain, Commercial, Quality, Clinical, Nonclinical etc. to develop solutions for need for regulatory intelligence (e.g. manufacturing monitoring supplier report) for GMPs status, recalls, warnings etc.- Develops strong relationships with Regulatory Policy, government affairs and commercial competitive intelligence groups within Otsuka through membership in cross functional task forces and projects.- Works with regulatory strategists to support the development of strategies, health authority and other materials to support development and post marketing.- Identifies early all major regulatory issues and ensures these are communicated to relevant stakeholders in a timely manner.- Responsible for leading / facilitating global review for health authority and trade association guidance’s and position papers and submitting high-level of quality final comments within timeframe allotted.- May serve as part of Clinical Regulatory and labeling teams as needed.- Trains and coaches internal and outsourced staff on regulatory intelligence sources and reporting methods.Supports or leads projects and non-project activities e.g. SOP/standards development, organizational initiatives, as needed. etc.
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• Serves as the patient support first point of contact for all cross functional product launch support and collaboration• Responsible for helping to establish a patient support strategy for each Otsuka launch product that is in line with brand team objectives• Drives patient access market research and understanding of complex managed market environments to drive strategic design and delivery of Otsuka patient support programs• Liaise with new Brand teams, Field Sales teams, Market Access, and Trade to establish appropriate Otsuka patient support programs:– Lead strategic support planning and execution– Drive patient access market research efforts– Integration of support resources– Alignment of strategy, objectives and tactics and budget• Establish and execute Otsuka patient support programs strategy for each launch brand/ Therapeutic area– Work collaboratively with ASSURE leadership to ensure vision and objectives are upheld while still supporting individual brand team objectives• Ownership of marketing agency relationship for launch products and therapeutic areas – Responsible for development and communication of all patient support program communication assets (print and web)– Support collateral development for Trade and Managed Markets teams– Collaborate with Brand teams to ensure on-time delivery of materials• Participates on brand advisory boards and market research projects• Exhibits expertise in reimbursement landscape/ disease state to ensure program, resources and materials are relevant for patient population• Collaborates with ASSURE leadership, Legal and E&C to ensure appropriate field education/ awareness of program offerings• Partner with Trade team to conduct SP business reviews as applicable • Partner with HEOR as applicable • Support tactical execution of brand plans by:– Aligning patient support program offerings with Brand team objectives– Healthcare Professional and Patient directed material development– Budget management: Driving implementation of new initiatives as well as planning for future initiatives
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The Compliance Manager will support the Compliance Counsel to ensure implementation of appropriate policies and procedures, support compliance training, conduct investigations and maintain a system of reporting and ensure the integrity of all compliance investigations. This role will help ensure the Compliance Program effectively promotes prevention, detection, and resolution of instances of improper conduct to ensure conformity to state or federal laws, regulatory requirements, and the standards of conduct. This role will also be responsible for following up on reported incidents of non-compliance, conducting and/or coordinating internal investigations and preparing reports on the incidents and investigation findings. • Reports to the Compliance Counsel in the Ethics & Compliance group• Assist the Compliance Counsel and internal investigations team with assessing incoming violations relating to sales, advertising, marketing and promotional activities; conducting interviews; gathering evidence; providing summary reports; participating in key meetings; and assisting with coordination of risk assessment and providing triage on investigation matters. • Support the development and implementation of programs to ensure compliance with federal and state laws governing the pharmaceuticals and medical device businesses, including, but not limited to, the Anti-Kickback laws, HIPAA, the FCA, the PDMA, the FDCA, FDAAA, the FCPA, and the federal Sunshine Act.• Support the Compliance Counsel through interactions with business partners such as Marketing, Sales Operations, Medical Affairs, and Sales leadership.• Provide support for field monitoring activities such as compliance ride alongs, speaker program monitoring, record reviews of call notes and emails, and other activities.• Assist with creation and revision of policies and procedures supporting the elements of an effective compliance program• Develop and deliver training or other methods to ensure all colleagues are educated regarding current developments in compliance including developing tools for use by internal customers.
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The Scientist/Sr. Scientist will be responsible for various activities under the direction of the manager or Director of Sterile Dosage Technologies. These include performing process development/scale-up studies, participating in the manufacture of cGMP clinical lots, and transfer of processes to clinical or commercial manufacturing facilities for new drug candidates or existing commercial products. - Participates in and oversees the drug development process of selected drug products (sterile and biologic) and API, ensuring robust and compliant manufacturing processes- Evaluates and optimized manufacturing processes using appropriate statistical analysis, root-cause-analysis, and quality-by-design principles.- Requires skills in analyzing process development data collected during scale-up and transfer processes to clinical or commercial manufacturing facilities.- Requires experimental skills in applying Statistical Design of Experiments (DOEs) and Quality by Design (QbD) to existing unit operations of pharmaceutical finishing processes.- Oversees development of various drug products and manufacturing activities that are performed by vendors and contractors and provides technical assistance during manufacturing.- Assists with the development of deparmental project timelines and project plans.- Coordinates regular technical review and project planning meetings with relevant CMC and supply chain functions, including frequent update meetings with OPC-Japan.- Ensures that contract manufacturers meet Otsuka requirements during development phases.Travel (approximately 15-25%)
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The Packaging Engineer is a technical resource responsible for assisting in the day-to-day operations ensuring the timely packaging of Otsuka’s products. The position’s key responsibilities are the support of Otsuka’s product portfolio including package and device development, component specifications and graphic arts related activities. The position requires interfacing with various domestic and global Otsuka teams to provide support for packaging processes for new and life cycle products and devices. The position requires an individual who has some knowledge and experience with packaging and device development as well as support systems. This individual will support packaging innovation and development projects within Packaging and Device Technology (P&DT) department. Also works on cost savings, line extensions, line trials and packaging specification management. They work with internal resources and packaging suppliers to achieve functional packaging goals.- Assist in the packaging development process, including the creation of packaging designs, prototype development, and performance testing.- Troubleshoot packaging concerns involving designs, materials and processes and provide creative, timely, and cost-effective solutions.- Work with various document management systems to generate component specifications and Bill-of-Materials (BOM) in coordination with CMOs. Also, generate protocols and reports in support of package testing including shipping and distribution, temperature controlled/refrigerated distribution, as well as engineering trials at CMOs.- Analyze engineering drawings and specifications of product to determine physical characteristics of item, special handling, environmental and safety requirements, and types of materials required for packaging.- Execute packaging development activities in alignment with the elements of design controls, and ensure that all packaging materials/systems comply with departmental and applicable regulatory requirements.- Evaluate and recommend packaging suppliers/vendors; periodically assist in conducting vendor reviews.- Work with commercial operations (package engineering, technical services, supply chain and distribution), quality management, marketing, finance and sourcing, as well as with packaging suppliers and CMOs.- Assist in the identification and implementation of cost saving initiatives related to packaging materials, labor, efficiency, transportation, and storage.- Work with CMOs to ensure that the packaging designs are optimized for manufacturability, to provide support to P&DT during new product-packaging qualifications and start-ups, oversee packaging activities and help support troubleshooting activities.- Support packaging equipment qualification protocols and process validation strategies (IQ/OQ/PQ/PV) in conjunction with CMOs.
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Provides statistical input in the clinical development plan and protocols and conducts statistical analyses and summary of clinical studies and integrated database to help advance the drug development process. This is a strategic and critical role in effectively and efficiently developing the process for approval of drug products. Responsibilities Protocol development- Provides statistical analysis plan, including study design, sample size, primary and secondary endpoints, and statistical analysis method.- Reviews protocol outlines and protocols.- Produces randomization codes.- Reviews CRF.- Reviews and approves database structure and edit-check specifications.- Reviews and approves other clinical documents, such as clinical operation manual, investigator brochure (I), etc.- Develops final tables and listings (and figures) for final study report (FSR).- Develops Table of Contents (TOC) and Tables & Listings templates.- Develops a detailed Statistical Analysis Plan (SAP) to document technical considerations.- Provides specs to SAS programmers for generating analysis datasets.- Programs efficacy analysis and produces final efficacy tables and figures.- Reviews final tables, listings, and figures.- Develops tables and listings (and figures) for other regulatory submissions.- Performs statistical analyses for PK/PD parameters.- Provides safety tables and listings for IND annual reports and PSUR.- Provides tables and listings for FDA meeting briefing packages.- Performs exploratory analyses.- Performs statistical analyses for marketing and Phase IV studies.- Performs statistical analyses for abstracts, posters and publications.- Develops final study report (FSR).- Provides Statistical Methods section.- Summarizes Efficacy Results.- Reviews FSR.- Handles FDA or other regulatory agencies’ contracts and regulatory meetings.- Drafts response to questions from regulatory agencies.- Participates in preparing FDA briefing packages.- Attends meetings with Regulatory Agencies.- Interfaces with FDA statistical reviewers and serves on the rapid response team to address inquiries during the NDA review.- NDA suissions- Provides Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety ISS) tables.- Reviews ISS and ISE reports.- Prepares briefing packages for FDA Advisory Meetings.- Participates in responding to Advisory Committee questions in NDA defense. - Provides statistical inputs on Clinical Development Plan regarding primary efficacy end point, go/no-go decision criteria, size of studies, and statistical methodologies.- Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development.- Reviews clinical, statistical, and regulatory literature for current clinical trial results, regulatory trends and new statistical methods to be applied on his/her assigned therapeutic area.- Represents clients (internal OPDC, OFRI, OPJ-C, and external partners) at FDA meetings, FDA advisory boards, or other scientific meetings.- Evaluates new statistical methodologies and software and their potential applications in our study design and analysis.- Serves as the Biometrics project team leader regarding the statistical analysis, tables and listings, data collection and quality, and overall timeline. If any potential issues arise within Biometrics functions, advises VP of Biometrics for action.- Assists in departmental planning and resource allocation and mentoring staff. Provides support for administrative duties as needed to the Senior Director. - Assists in proposal development, FTE allocation, budget projections, and corporate presentations.- Provides technical supervision over other biostatisticians assigned to his/her therapeutic area and assigns them the statistical tasks.- Takes full responsibility in managing biostatistical tasks (as listed below) for one therapeutic area and provides strategic technical support to other clinical projects.- Provides technical direction to supporting statisticians working on projects on a day-to-day basis.
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The Assoc. Scientist/Scientist, Pharmacometrics will perform high quality pharmacometrics (PMx) analyses essential for internal decision making and successful approval with the support of his/her supervisor. He/she will represent PMx in project and trial teams as well as author PMx reports and develop PMx strategy with the support of his/her supervisor. Job Responsibilities- Develop PMx strategy and contribute to the clinical development plan, and implement model-informed drug discovery and development (MIDD) in clinical development projects with support of supervisor.- Ensure timely delivery of PMx analyses for internal decision making throughout clinical drug development and registration with support of supervisor (e.g., non-linear mixed effects models, model-based meta analyses for dose selection, labeling, optimizing clinical study designs and pediatric development).- Ensure timely delivery of PMx internal documents with support of supervisor. (e.g., dataset specification, PMx analysis plan, and PMx report).- Ensure timely delivery of documents with support of supervisor. (e.g., clinical development plan, pediatric investigational plan, submission documents).- Represent PMx in clinical development teams and in initiatives and working groups with support of supervisor.- Organize and manage projects with external organizations with support of supervisor (e.g., academic institutions or CROs).Travel 20%
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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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Otsuka is looking for candidates with expertise in machine learning, artificial intelligence, statistical data analytics, and applications. The prospective candidate must have an excellent knowledge of advanced methods, and experience in applying those methods to a variety of applications. The successful candidate will be energetic, open to grow in new directions, work with a team of scientists and practitioners from different functional areas to solve problems in pharmaceuticals. - Establish and implement end to end proof of concept for data analyses across functional areas- Create innovative methodologies for data - Build proof of concept systems - Establish strategic partnerships with technical leadership across functional areas- 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)
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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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Seeking and individual with excellent leadership, operational execution, process transformation, change management and communication capabilities. The Senior Director of Operational Excellence will lead strategic, transformational and operational improvement projects working with a cross functional team to enable process, technology and organizational effectiveness. This individual will seek to identify transformational opportunities to drive growth, efficiency and productivity, as well as lead the creation, development and tactical execution of implementation plans. - Proven business leader with the desire and experience to drive strategic change and operational execution.- Partner with Businesses to design and support effective and efficient organizations by implementing operational improvements, process enhancements, organizational effectiveness, and technical solutions. Assist with the change management development, communication and execution plans.- Lead a portfolio of projects by managing different client groups, conflicting schedules and resources. Able to resolve conflicts and identify solutions to move projects to successful completion. Able to assess and perform current process mapping and design value-added future process environment. Able to develop transition plan to move organization from current process to future state.- Motivates, coaches and develops those individuals across the organization involved in leading or executing operational excellence or continuous improvement objectives; mentors individuals at all levels to support them through the adoption of lean principles and practices- Assist in the development, leadership and execution of the continuous improvement long range plan inclusive of project selection, resource management and technology innovation- Utilizes best practices from Lean, Six Sigma, DMAIC and change management methodologies- Ability to effectively communicate current processes and future solution recommendations- Develops business improvement planning processes that align and prioritize improvement projects linked to business strategy and business planning at corporate and operational levels
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Responsible for providing end-to-end Interactive Response Technology (IRT) support to clinical project teams including but not limited to gathering study specific IRT user requirements, creating IRT standards, managing vendor performance, managing and supporting UAT activities, monitoring system change requests, and supporting training & education for stakeholders. Responsible for clinical supply activities for Phase I-IV assigned studies, including coordination of packaging, labeling, and distribution.- Execute IRT development process from project kickoff to system go live, ongoing system change control, maintenance, and system closeout.- Submit request for proposal and review/modify IRT proposals in conjunction with management.- Work with the internal stakeholders and IRT vendors to develop study specific IRT requirements. Responsibilities include collaboration with vendors and internal stakeholders to define requirements and develop implementation plans.- Manage UAT activities including coordination of internal stakeholder and CRO participation, and drafting UAT scenarios and performing testing as required. - Manage vendor performance and relationship(s) at the clinical study level. Responsibilities may include performing root cause analysis and identifying corrective/preventative actions, and serving as a point of escalation for vendor issues.- Ensure vendor system development processes align with Otsuka Quality Assurance requirements.- Monitor system change requests. Works with the clinical project team to identify system changes and ensure completion of the changes through project life-cycle.- Monitors and analyzes system change requests, and identifies corrective actions for utilization of standards.- Liaise with Clinical Supply Project Leads and Clinical Supplies Forecasting Manager to ensure optimal and effective use of IRT medication management strategies.- Provide IRT support in the following areas:- Data transfer issue resolution between IRT vendors and internal/external systems.- Development/maintenance of relevant documentation, including applicable SOPs, job aids, and guidance documents.- Process improvement activities.- Training and education for stakeholders including development of training material.- Responsible for clinical supplies management of assigned projects, including coordination of packaging, labeling, and distribution
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Reporting to the Director of Device & Drug Delivery Technologies, the Manager, Health Technologies and Development is a technical expert who is responsible for managing the development of OPDC’s drug and drug-device combination projects following the requirements of OPDC, US and International Requirements as applicable. A technical person that is an individual contributor that manages the technical aspects related to products supplied by CMO’s including product development, transfer, scale-up, trouble–shooting, manufacturing, testing, etc. of existing and new products. The position will require an individual who has knowledge and experience with solid and some sterile dosage form development and transfer to TPMs. The individual should have experience which includes industrial pharmacy, pharmaceutical engineering and pharmaceutical dosage forms. Must be capable of leading cross-functional project teams to support transfer of manufacturing processes. The position may involve travel up to 15 - 30%. The Manager will also be responsible for evaluating, developing, and implementing new and innovative drug, drug-device/delivery technologies, and maintaining expertise in state-of-the-art technologies available in industry and academia. This position will be an individual contributor role but will frequently require management of outside resources as well as leadership of project teams. The individual should have experience in working effectively and influencing cross functional project teams which includes both internal and external team members. The Manager is a technical expert in the field of oral solid pharmaceutical product development, technology transfer and scale up who can effectively navigate, influence 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 product and process development, early to late stage product and process development, technology transfer, scale-up and validation. The Manager should demonstrate strong technical writing and presentation skills and be able to translate technical information to non-technical audiences and Sr. Management. This position requires 6-8 years of applicable experience in the pharmaceutical, biotechnology or medical device industries. The position may involve frequent domestic and international travel up to 15 - 30% as projects require. Develop and perform the tactical activities:- Ensure formulation development at Contract Development and Commercialization Organizations (CDMO)- Ensure efficient transfer of products and on-going product support all products to CMO’s.- Third Party Vendor Selection – working with key stakeholders (e.g. QM, Sourcing, Finance) support a program for Vendor Management of all activities to balance internal versus external resources- Develop and maintain departmental knowledge, experience, and expertise in state-of-the-art devices for pharmaceutical products.- Support strategic sourcing evaluations with key suppliers and partners to leverage optimal supply base costs for all products- Identify and implement supply chain opportunities to realize improvement in service and cost.- Assure adherence to latest worldwide regulatory rules and guidances concerning devices and work to develop device risk mitigation.- Maintain and update documents required for regulatory compliance assuring PMA/510(k) and NDA-CMC filings are complete and accurate.- Initiate, evaluate and implement proposals for improved manufacturing processes and recommend actions.- Assure adherence of reports to latest worldwide regulatory rules and guidances concerning technology transfer, robustness, PAT, process validation, packaging, etc- Assist management and staff in improvement of commercial product quality and reduction of commercial manufacturing costs.- Develop and maintain departmental knowledge, experience, and expertise in state-of-the-art manufacturing methods and equipment for pharmaceutical products.- Maintain and update department documents required for regulatory compliance assuring CMC filings are complete and accurate.- Identify and implement supply chain opportunities to realize improvement in service and cost.- Develop and monitor appropriate KPI’s and metrics to support the businessDue diligence- Ensure rigorous supply chain due-diligence has been completed for potential product acquisitions thus enabling optimal integration of all newly acquired DEVICE products 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.- Identify and manage the development and implementation of policies, procedures, and standards for the Packaging & Device Technology department.- Evaluate and recommend strategic directions for new and innovative delivery device technologies to support new and life-cycle management projects.Program management of Pharmaceutical Technology projects:Develop project plans and corresponding project managements tools to support the execution of all projects- Staff Development- Coach staff in evaluating CMO proposals, manufacturing processes, trouble-shooting and general support to manufacturing. - With Associate Director/Director, provide direction and career development opportunities for subordinates.- Project Budget- Develop and manage project budget appropriately.
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The Manager, Sales Operations Support position requires a commercial operations professional who possesses strong customer service focus, has a solid understanding of pharmaceutical field force help desk support processes and practices, pharmaceutical sales operations functions and processes, field force communications and training, as well as a working knowledge of commercial applications, systems and underlying data.As a member of the Sales Operations team, the Manager, Sales Operations Support represents the needs and interest of Otsuka’s therapeutic area field forces and serves as escalation point for help desk tickets, field inquiries, solution service request, remedial training requests and other issues/requests that require Home Office intervention or approval for their resolution.The Manager, Sales Operations Support assist the sales automation solutions business owners with the management, administration and training of the organizations Customer Relationship Management (CRM) solutions and other commercial applications, for the implementation of new automation capabilities, systematic enhancement of underlying business processes and the maintenance of the integrity and quality of enterprise data.The Manger, Sales Operations Support position requires the ability to interact with a variety of internal Sales Operations, Information Technology, Business Services and other home office departments, co-promotion partners and outside vendors across the matrix. Responsibilities also include the evaluation of new CRM tools with potential commercial applications, vendor management support and project/program management support.• Leads CRM Support Tier-2/Tier-3 triage activities and acts as a centralized coordination point to review and resolve field inquiries and other issues/questions escalated from the Tier-1/Tier-2 Help Desk through partnering with various internal & external stakeholders including Information Technology, Sales Operations, Data Management, Segmentation & Targeting, Legal & Compliance, Third Party Vendors and Business Partners. • Works with Business Service group on overseeing Tier-1/Tier-1.5 Help Desk vendor activities, and ensure user issues and questions are addressed in a timely manner with high quality. This includes training of help desk specialists and providing them assistance so that they can perform their job effectively, defining SOP’s and SLA’s, evaluating of help desk metrics, and proactively soliciting user feedback, etc. • Supports CRM solutions training lead, assists with the coordination of training department and training vendor activities, creates SFA training content and modules, prepares training data for CRM training courses, and conducts field force training for new systems, new hires and ongoing remedial training. Coordinates train-the-trainer sessions and maintains documentation of system updates and user manuals. Authors’ communications for enhancements, changes, best practices and FAQ’s.• Represents the needs and interest of Otsuka field forces and conducts frequent meetings with field force stakeholders, sales operations colleagues and Learning & Development to collect feedback on CRM processes and toolkit effectiveness, track toolkit utilization and provide field support level metrics.• Supports the administration and maintenance of Customer Relationship Management (CRM) solutions and partners with IT on the analysis, design and implementation of new CRM applications, enhancements, feature releases and special projects, including defining roadmaps and project plans, project status reports, issue logs, testing plans, training & transition plans, etc.• Assists with the Development and maintenance of rigorous quality control process and measures that ensure the accuracy of all information disseminated though CRM applications to the field force. Assists maintaining the integrity of enterprise data systems and supports enterprise information governance efforts.• Supports system integration testing (SIT) and coordinates user acceptance testing (UAT) for CRM projects including authoring testing plans and test scripts, tracking testing results, defining tollgates and testing closure.• Support PM/PMO efforts, manages tasks, dependencies, issues & risks across Sales Operations initiatives and formal projects, including the coordination with other commercial organizations, OIT, vendors, Co-promoters and other business partners to ensure completion on time and within budget. Assist with the long-range planning and implementation of customer relationship management (CRM) technology solution for the field force.• 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.).
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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
