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Reporting into Director, Business Information Management, the Senior Manager/Associate Director - R&D eSolutions Delivery is responsible for delivery implementation, execution, integration and transformation of clinical trial technologies and digital technologies. This role will closely partner and collaborate with various global R&D business functions, the internal and external IT services organizations, various suppliers, and other key stakeholders to identify and enable enterprise grade cost effective digital, mobile, and eSolutions leading to the accomplishments of the following key goals/objectives in addition to applicable operational, strategic, and fiscal responsibilities:- Improved user experience and predictable delivery of business outcomes through technology enablement- Improved cycle time for R&D deliverables through digitalization and automation- Technology driven and enabled productivity/efficiencies- Managing budget, schedule, timeline and release management activities on an ongoing basis- Enabling near real time accessibility of R&D data to drive greater insights and rapid decision makingKey Job Responsibilities- Develop and execute a continuous improvement framework within OIT R&D team to drive innovative process and system improvements that enable compliant and efficient R&D processes and clinical trial delivery.- Participate and contribute to R&D Innovation Forums to identify opportunities for enabling technical capabilities that will improve trial operations and outcomes.- Lead, develop, coordinate and implement strategic technical projects – prototypes and pilots, across OIT and R&D functions aligning with business objectives.- Develop applicable business cases and key performance indicators (KPIs) to demonstrate overall return on investment.- Coordinate across various delivery teams, architects, support teams and business stakeholders to understand and drive all aspects of solution delivery including but not limited to managing schedule, priorities, governance plan, agenda setting, UAT coordination, demand management, change management, communication and establish delivery cadences.- Management, metrics tracking and successful delivery of innovation and continuous improvement and transformative IT solutions.- Identify, collect and analyze relevant metrics to develop a comprehensive understanding of R&D processes, clinical trial execution, technology operations and overall platform performance including but not limited to quality, cycle time, cost, integration, and the voice of the customer (e.g., business functions, patients, consumers, affiliates, partners and vendors).- Collaborate on the development of a communication tool to provide at-a-glance views of metrics summaries, key trends, comparisons and exceptions. Develop reports using this data and highlight movements in key process metrics over the continuous improvement lifecycle. Make continuous improvement recommendations based on this data.- Maintain a solid knowledge of the end to end Clinical Development pathway. Understand upcoming technical strategy and directions that regulatory agencies will be expecting movement towards in the future.- Collaborate with experts to understand the potential impact on Otsuka’s end to end processes – technically, operationally, & fiscally. Communicate these findings and recommendations to OIT Leadership Team.- Participate and contribute to technical vendors and digital/eSolution assessments for best fits based on technical and business strategy and portfolio across R&D clinical eco-systemsTechnical Leadership/Management- Act as a change agent to create an operational and technical excellence culture and deliver measurable outcomes.- Establish and maintain strong working relationships with both internal and external collaborators and stakeholders across all Otsuka geographical regions. Includes close working relationship with the R&Doperational and clinical development teams and their direct reports- Establish agile and dev-ops delivery framework to meet competition business demand.
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Directs or assists staff member(s) or independently reviews, revises and approves content and context required of promotional materials for prescription drug and drug-device productsUtilizes regulatory knowledge to provide support and strategic input in structuring promotional claims. Ensures that promotional and training materials meet regulatory and company requirements. Must be effective in managing work and resolving conflicts. Must deal with ambiguity and be action oriented.Must demonstrate a high level of understanding of product labeling and promotion compliance. The ideal candidate should demonstrate a high level of understanding in both disciplines.May be assigned additional responsibilities as deemed necessary. • Supervises direct and indirect report(s) or acts to ensure all promotional materials are in compliance with relevant laws and regulations. Analyses and interprets new regulations and Guidances as well as monitors and determines the impact of the Office of Prescription Drug Promotion (OPDP) correspondences and enforcement actions (e.g., WARNING Letters).• Supervises direct and indirect report(s) or reviews promotional and commercial communication materials to ensure that the information conveyed is consistent with the product labeling and is suitable for their intended audience and use. Provides alternative suggestions to allow for consistent messaging. • Supervises direct and indirect report(s) or reviews promotional and commercial communication materials to ensure that the information conveyed is consistent with the product labeling and is suitable for their intended audience and use. Provides alternative suggestions to allow for consistent messaging.• Responsible for final review and approval of promotional and sales training materials, and corporate communications, as appropriate. Ensures product promotional materials are submitted to OPDP on Form FDA 2253 in a timely manner as per regulations, and that materials are archived as per company policy.• Monitors and informs others of changes in US labeling and promotional regulations as well as corporate policies and procedures, as appropriate. Utilizes these changes in modifying company procedures.• Develops and designs improvements to policies, processes, quality, and system tools. Manages contracts for contractors and consultants as appropriate.• Attends cross functional teams: Global Regulatory Team (GRT), Global Labeling Team (GLT).• Provides training to OAPI/OPDC employees on regulations for promotion compliance as appropriate.• Acts as liaison between the company and OPDP. Arranges and leads meetings with OPDP as appropriate.
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The Senior Manager of Health Economics & Outcomes Research (HEOR) is responsible for supporting program directors in the development of therapeutic area specific HEOR projects and their tactical execution across a variety of potential product types (pharmaceutical, device, digital health). The individual will ensure the successful implementation of assigned programs/projects through appropriate research design, project management, analysis, interpretation and dissemination of HEOR evidence to appropriate stakeholders. The Senior Manager HEOR is responsible to ensure that health economics, outcomes and quality data are produced to ensure the scientific medical standing of the potential value and real-world impact of Otsuka products across the area of therapeutic interest for payers, healthcare providers, and patients and caregivers. Job responsibilities: Working in collaboration with program directors- Design and implement health economics and outcomes research 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)- Liaise with cross-functional teams including market access, payer marketing, medical affairs and clinical development to define payer value proposition of Otsuka portfolio of products- Implement evidence generation research studies by either collaborating with internal Otsuka programmers and data analysts or via collaboration with external vendors and academic institutions- Support publication planning and execution coordinating with publication teams and Otsuka Scientific Communications personnel.- Support preparation of medical or payer advisory meetings to solicit feedback on Otsuka products and therapeutic areas specific disease impacts.- Identify and support the execution of projects that directly support the economic and quality strategy for Otsuka products- Evaluate the healthcare economic, outcomes and quality-related value of products/therapies vs. other therapies and/or interventions with data from clinical trials and/or epidemiologic studies and produce data and tools- Work with HCPs, payers and other appropriate organizations to uncover their evidence needs and to develop economic tools and models for such audiences- Assist department leadership in ensuring the alignment of evidence generation strategy with the with overall product strategies- Assist Outcomes Management personnel in developing patient and caregiver education and payer awareness materials on disease, unmet need, and quality of care- Assist in development and/or develop product dossiers and other projects that support different aspects of formulary submissions
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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
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Provides financial planning and analytic support to brand teams and various departments. Expected to work with Brand and Department leads to develop and manage budgets and forecasts, review actuals, provide analysis of variances and identify opportunities for more efficient use of resources. Required to utilize reporting packages, databases and visualization tools to analyze and communicate information to senior level financial and non-financial executives. Perform NPV, ROI/IRR calculations for internal projects and business development activities.• Partner with Brand Teams and Departments to deliver financial commitments – act as financial advisor for business, including: a) Coordinate and develop budgets, forecasts and long term plans per the Financial Planning Calendar, for all lines of the P&Lb) Understand key drivers of performance and Budget variances for expenses and revenue c) Identify areas of opportunity for spending efficienciesd) Incorporate and share Financial Stewardship principles across the commercial teame) Help manage accrual and accounting process across the business, and provide business with uncommitted and unspent fundsf) Understand the underlying financial risks and opportunities for each department.• Use financial analyses and data visualization tools to help measure, communicate and prioritize results and investment decisions.• Develop and maintain analysis reports that help client and senior management better understand and manage the business.• Support and help manage data integrity, including summarizing all types of expenses.
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Leads preparation, review, and update of content for the development and maintenance of labeling and labeling components. The ideal candidate will be results-oriented with concerns for quality and collaboration. They will demonstrate a high-level understanding of labeling content requirements, regulations and guidance in support of labeling strategies. May be assigned additional responsibilities as deemed necessary. Strategic Responsibilities:• Develop and maintain Target Product Profile, Company Core Data Sheet (CCDS) and local labels (US, EU, Canada)• Evaluate and communicate risks associated with CCDS content updates and implementation strategies• Understand and address key scientific, clinical, medical and payer needs, including commercial differentiation strategies• Assess competitor labeling - understand precedents & opportunities for Health Authority (HA) discussions• Understand implications for promotional and HTAs from local labeling• Support global HA interaction strategy to discuss key labeling elements• During HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies• Develop clear communications for senior management and SOP approvers to streamline and facilitate final label negotiations and approvalOther Responsibilities:• Lead labeling cross-functional project sub-teams and facilitate cross-functional leadership team committee meetings• Participate in global regulatory affairs & safety governance sub-teams• Coordinates the internal labeling approval process as specified by standard operating procedure.• Complete finalization and formatting of USPI, SmPC and Product Monographs• Manage labeling negotiations during registrational review• Develop and maintain Core Data Sheet in electronic data management system (EDMS)• Support local regulatory offices to develop country specific labeling that is consistent with the Core Data Sheet• Manage post-approval changes and country-specific updates• Manage SOP reviews and approvals• Support all tracking, planning and storage activities related to labeling including any computer or manual system related activities• Leads inspection readiness activities related to all global labeling components. • Follows and formulate improvements to labeling policies, processes, quality, and system tools. • Ensure policies and practices are maintained to ensure local labels are consistent with global labeling• Present to Labeling Oversight Committee: Ensure Core Data Sheet accurately reflects current understanding of benefit/risk profile• Provides training to employees on regulations for labeling compliance as appropriateOrganization Structure:• Reports into Director, Global Labeling and preferably based in Princeton, New Jersey office.
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This position will be responsible for the collection, documentation and processing immediately reportable events from clinical trials and all adverse events from post marketing spontaneous reports in accordance with Global Pharmacovigilance Regulations and the company's Standard Operating Procedure. Closely Monitor the safety profile of assigned products, both in development and post-marketing. Actively contributes to the preparation of aggregate and ad hoc safety reports. The position also includes but is not limited too:- Maintains accurate and complete knowledge of all investigational and marketed products being monitored by Otsuka, co-marketers, co-sponsors, and/or affiliates.- Collects, documents, and processes adverse event (AE) reports from clinical trials and post-marketing sources in accordance with company Standard Operating Procedures (SOPs) and work practices to ensure and maintain regulatory compliance. This includes detailed review of source documentation, assessing cases for reportability, accurate data entry, and quality check- Initiates follow-up calls to investigative sites and spontaneous reporters, as needed, to retrieve missing AEinformation, according to SAE reporting requirements, regulatory guidelines, and department SOPs.- Conducts periodic reconciliation of SAEs between drug safety and clinical trial databases for ongoing clinical studies with little or no supervision- Maintains a thorough understanding of internal and external interactions, and scope of work assigned to the department- Assists with conducting literature searches for assigned products- Drafts safety summaries for inclusion in medical information write-ups, including analysis of similar events in alert reports- Supports the generation of Aggregated Safety Reports (e.g. EU Annual Safety Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks- Serves as resource for CS & PV Associates and Assistants- Maintains effective working relationships with Investigational study site staff- Provides training on the technical and operational aspects of programs to CS & PV team members (and other OPDC staff as appropriate).- Communicates product safety issues to team members in a timely manner.- Utilizes regulatory and GCP knowledge to assist team members in the assessment of adverse event reports- Represents CS & PV at interdepartmental team meetings- Represents CS & PV at meetings conducted with licensing partners, agents, CROs, and clinical site investigators- Interact on a regular basis with contract drug safety vendor (data management, case processing, call center, etc) to resolve safety-related issues- Reviews and provides input on protocols, case report forms, investigator brochures, package inserts, and NDA/PLA documents- Contributes to presentations, discussions, and data summaries on safety issues at meetings with external groups such as licensing partners, agents, contract research organizations, independent safety monitoring committees, and clinical site investigators
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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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Working closely with supervisor or other members of the department, the Associate Program Manager (APM) supports the Clinical Program Management team, in establishing and tracking project scope, timelines, activities, and budgets. The APM serves as a liaison to support program management communications to team members. Working proactively with manager or other members of the department, the APM provides input to identify and resolve issues in a timely manner so as to meet project objectives. The APM is committed to maintaining a positive, results-oriented work environment, building partnerships, modeling teamwork, and communicating in an open, balanced and objective manner.- Under the direction of manager, responsible for supporting departmental and corporate initiatives to drive process improvements.- Provides professional program management support Manages project information for assigned projects 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.- Maintains project timelines and prepares routine status reports ensuring timely and accurate project information is available- Responsible for maintenance of the project actions, decisions and issues (ADI) log for project team interactions.- Supports the project teams toward implementation of the strategic and operational plans and tracks progress to goals.- Assists manager or other senior member of the department to implement the Global Development Commercialization Plan (GDCP) for their project, driving to the next action point, decision point development/analysis, and associated analytics- Manages and tracks program progress as assigned on a continual basis, identifying and tracking both cross-project and cross-functional issues, scope issues at project and program level, timeline issues, and budget issues. Works proactively with manager and the project team to achieve timely resolution of these issues in order to achieve approved program objectives. These activities include those that are outsourced.
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Provides leadership and day-to-day guidance to CROs and OPDC functional areas for assigned protocols. Interacts with expert physicians, investigators, vendor/CRO personnel, and functional area staff to ensure that the clinical protocol(s) are run according to ICH, FDA, and OPDC guidelines. Ensures compliance with FDA and international regulations, GCPs, and SOPs. - Acts as the operational lead for assigned domestic and global protocol(s).- Contributes to the development and implementation of study strategy.- Contributes to the development of protocol outlines, protocols, amendments, and Case Report Forms, as assigned.- Serves as primary CRO contact. Oversees the CRO in their conduct of the day-to-day operations of assigned protocol(s), including:- Development of ICFs and other study-related documents.- Coordination of local insurance policies.- Study planning, including Operations Manual and other planning documents.- Recruitment strategy.- Country and site selection.- Study-related tracking (enrollment, monitoring, regulatory documents, etc).- Trend analysis and risk mitigation.- Ensures accuracy and completeness of study-related tracking (enrollment, monitoring, regulatory documents, etc.). Provides study status information to Manager/Senior Manager/Associate Director Clinical Research.- Reviews and analyzes the data from tables and listings. Trains the CRO in OPDC data review processes and proper recording and management of findings.- Contributes to Clinical Study Reports, as assigned.- Acts as a resource to the CRO staff to identify problems and propose solutions to maintain projects within designated timelines and budgets.- Responsible for the quality of the preparation, presentation, issue identification, and follow-up for all portions of investigator meetings.- Co-ordinates training programs for study staff and CROs prior and during study conduct.- Communicates and coordinates study-related activities across all relevant cross-functional areas.- Ensures that assigned studies are conducted following the protocol, ICH, GCP and all applicable global regulatory requirements.- Reviews and approves Oversight Reports; familiar with trends.- Conducts Monitoring Oversight Visits. May serve in the Clinical Quality Lead role for Early Phase or other protocols with small numbers of sites.- Approves selection of appropriate clinical staff by the CRO.- Ensures smooth communication and interaction on project-related activities.- Provides ongoing analysis, interpretation, and presentation of data.- Participates in process and continuous improvement initiatives as assigned.
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To be a credible source of evidence based information that demonstrates the value of Otsuka products from the clinical, economic, and humanistic standpoint and works in partnership with providers, payers and other key stakeholders to apply practical real-world solutions to improve patient outcomes. Key Job Responsibilities:- Ensure appropriate dissemination of clinical information, knowledge and services in a timely, ethical, and customer-focused manner.- Keep abreast of the current literature, therapeutic issues, and competitive landscape related to psychiatric disorders.- Establish status as a knowledgeable and trustworthy medical and scientific resource for opinion leaders with expertise and knowledge of supported product(s), treatment trends, clinical trials, and scientific research.- Communicate current and emerging clinical research data to opinion leaders in response to unsolicited inquiries.- Identify medical experts to provide services as speakers, consultants, and investigators.- Engage national, regional and local payers, payer advisors and influencers that make patient access and reimbursement decisions.- Communicate cost effectiveness evidence that address payer needs and priorities; partner with providers and payers to put into practice decision support and care management tools and apply real-world evidence and solutions in the practice setting.- Deliver scientifically focused balanced and objective educational presentations to groups of strategic importance such as hospital and payer P&T committees.- Train speakers for promotional programs on product knowledge, clinical/scientific data, and information consistent with established company policies and compliance guidelines.- Participate and interact with opinion leaders, local practice leaders and other key stakeholders, including preparing moderators at national, regional and local conferences, advisory boards and other approved gatherings.- Gather scientific and competitive intelligence as well as customer insights during interactions with opinion and practice leaders or attendance of congresses and communicate to relevant Medical Affairs and Clinical Development personal.- Evaluate and assess potential investigational sites for participation in Otsuka-sponsored clinical studies as well as educate investigators about the study drug and pharmacovigilance procedures.
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Provides customized information strategies, solutions, and services for internal clients globally to support business decisions in clinical development and commercialization. Manages global online information portals and systems, including assessment, licensing, deployment, vendor relationships, administration, and usage monitoring. Manages key stakeholder engagement and promotion of online resources and information services. Develops and manages global user training programs. Supervises Princeton-based team. Serves as project manager for global projects. Leads administration and development of department SharePoint intranet site. Evaluates and deploys new information management, organization, and search technologies.- Provides customized information strategies, solutions, and services for internal clients in the U.S., Europe, and Japan, to support business decisions in clinical development and commercialization. Works with clients to translate information needs into effective search strategies, uses specialized resources to locate information then evaluates, analyzes, and delivers quality research results.- Manages global online information portals and systems, including assessment, licensing, deployment, vendor relationships, administration, and usage monitoring- Manages key stakeholder engagement and promotion of online resources and information services, through individual and group meetings and marketing efforts across multiple channels.- Develops and manages global user training programs, including identifying needs, coordinating with vendors, and implementing processes for measuring effectiveness.- Supervises Princeton-based IRC staff.- Serves as project manager for global projects.- Leads administration and development of department SharePoint intranet site, including needs analysis, content updates, interface enhancement and upgrade deployments, and usage tracking.- Evaluates and deploys new information management, organization, and search technologies.- Supports tracking and monitoring of products and industry trends to provide competitive and business intelligence to help business enhance strategic planning.Travel (approximately 5%)
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About our Global Clinical Development (GCD) Team:- 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). - Otsuka is seeking an Associate Director/Director, Global Clinical Development for our Rockville, MD or Princeton, NJ offices, who will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practice (GCP). The incumbent will be responsible for the evaluation and clinical development of CNS compounds at different stages of development for a global healthcare market. Responsibilities- Consults with patients (or their representatives), clinical, regulatory and scientific leaders, while thoughtfully applying 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, as well as 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 the 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. Provides strategic direction and editing to provide concise, clear and convincing argumentation in all such written and verbal communications.
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Reporting to the Associate Director of Device & Drug Delivery Technologies, the Sr. Manager – Device Development is a technical expert who is responsible for managing the development of OPDC’s combination products, drug delivery device related projects following the requirements of OPDC, US and International Requirements as applicable. The Sr. Manager will be responsible for the creation and management of design history files and technical dossiers for combination and device projects for new and existing products. Additional responsibilities include creation and management of product and component specifications, design control documents, engineering protocols and reports and frequent presentations to project teams and management. The Sr. Manager will also be responsible for evaluating, developing, and implementing new and innovative device/delivery technologies, and maintaining expertise in state-of-the-art technologies available in industry and academia. This position will frequently require management of outside resources as well as assigned and/or unassigned leadership of project teams in a matrix organization. The Sr. Manager is a technical expert in the field of combination products & drug delivery devices 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 engineering, device regulatory, device quality systems (cfr 820, ISO 13485), human factors engineering principals, risk management for medical devices (ISO 14971), etc. The Sr. Manager should demonstrate strong technical writing and presentation skills and be able to translate technical information to non-technical audiences. This position requires 8-12 years of applicable experience in the pharmaceutical, biotechnology or medical device industries. Support the vision for the Device Technology function- Support and implement a vision with appropriate strategies that supports the OPDC objectives and aligns with the business and OPCJ/OPDC/MDD development programs- Work with the Associate Director Device Technology, and other functions including Packaging, Supply Chain, Clinical Supplies Operations, Quality Control, and Quality Management to support strategies for product and process improvements- Support the development of flexible and compliant product development process. Develop and support the strategic activities of the department:- Support and implement appropriate filing strategies working with OPCJ, OPDC, MDD and OAPI departments to support registration of all new products and life-cycle management products.- Initiate and manage the development and implementation of policies, procedures, and standards for the Device Technology department.- Evaluate and recommend strategic directions for new and innovative delivery device technologies to support new and life-cycle management projects. Develop and perform the tactical activities:- Ensure efficient transfer of products and on-going product support all products to CMO’s from device perspective.- Develop and maintain departmental knowledge, experience, and expertise in state-of-the-art devices for pharmaceutical products.- Assure adherence to latest worldwide regulatory rules and guidance concerning devices and work to develop device risk mitigation.- Create, maintain and update device related documents required for regulatory filings and complianceProgram management of Device projects:- Develop project plans and corresponding project managements tools to support the execution of all projects- Manage cross functional teams (including 3rd party resources)- Lead Human Factors Engineering & Usability activities
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To be a credible source of evidence based information that demonstrates the value of Otsuka products from the clinical, economic, and humanistic standpoint and works in partnership with providers, payers and other key stakeholders to apply practical real-world solutions to improve patient outcomes.Key Job Responsibilities:- Ensure appropriate dissemination of clinical information, knowledge and services in a timely, ethical, and customer-focused manner.- Keep abreast of the current literature, therapeutic issues, and competitive landscape related to psychiatric disorders.- Establish status as a knowledgeable and trustworthy medical and scientific resource for opinion leaders with expertise and knowledge of supported product(s), treatment trends, clinical trials, and scientific research.- Communicate current and emerging clinical research data to opinion leaders in response to unsolicited inquiries.- Identify medical experts to provide services as speakers, consultants, and investigators.- Engage national, regional and local payers, payer advisors and influencers that make patient access and reimbursement decisions.- Communicate cost effectiveness evidence that address payer needs and priorities; partner with providers and payers to put into practice decision support and care management tools and apply real-world evidence and solutions in the practice setting.- Deliver scientifically focused balanced and objective educational presentations to groups of strategic importance such as hospital and payer P&T committees.- Train speakers for promotional programs on product knowledge, clinical/scientific data, and information consistent with established company policies and compliance guidelines.- Participate and interact with opinion leaders, local practice leaders and other key stakeholders, including preparing moderators at national, regional and local conferences, advisory boards and other approved gatherings.- Gather scientific and competitive intelligence as well as customer insights during interactions with opinion and practice leaders or attendance of congresses and communicate to relevant Medical Affairs and Clinical Development personal.- Evaluate and assess potential investigational sites for participation in Otsuka-sponsored clinical studies as well as educate investigators about the study drug and pharmacovigilance procedures.
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To be a credible source of evidence based information that demonstrates the value of Otsuka products from the clinical, economic, and humanistic standpoint and works in partnership with providers, payers and other key stakeholders to apply practical real-world solutions to improve patient outcomes.Key Job Responsibilities:- Ensure appropriate dissemination of clinical information, knowledge and services in a timely, ethical, and customer-focused manner.- Keep abreast of the current literature, therapeutic issues, and competitive landscape related to psychiatric disorders.- Establish status as a knowledgeable and trustworthy medical and scientific resource for opinion leaders with expertise and knowledge of supported product(s), treatment trends, clinical trials, and scientific research.- Communicate current and emerging clinical research data to opinion leaders in response to unsolicited inquiries.- Identify medical experts to provide services as speakers, consultants, and investigators.- Engage national, regional and local payers, payer advisors and influencers that make patient access and reimbursement decisions.- Communicate cost effectiveness evidence that address payer needs and priorities; partner with providers and payers to put into practice decision support and care management tools and apply real-world evidence and solutions in the practice setting.- Deliver scientifically focused balanced and objective educational presentations to groups of strategic importance such as hospital and payer P&T committees.- Train speakers for promotional programs on product knowledge, clinical/scientific data, and information consistent with established company policies and compliance guidelines.- Participate and interact with opinion leaders, local practice leaders and other key stakeholders, including preparing moderators at national, regional and local conferences, advisory boards and other approved gatherings.- Gather scientific and competitive intelligence as well as customer insights during interactions with opinion and practice leaders or attendance of congresses and communicate to relevant Medical Affairs and Clinical Development personal.- Evaluate and assess potential investigational sites for participation in Otsuka-sponsored clinical studies as well as educate investigators about the study drug and pharmacovigilance procedures.Travel Expectations: 60-80% travel time within assigned territory
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The Manager, Clinical Programming is responsible for the management of all activities within the Quality Control and Analysis Programming groups. Key Job Responsibilities:- Development of Analysis Programming groups' training manuals to promote standard processes and procedures.- Provides analysis programming including generating reports, tables, listings, graphs, statistical analyses, and applications to satisfactorily fulfill requirements. While some programming is maintenance programming (modifying existing programs), the majority is writing new programs.- Collaboration with other function managers and Otsuka departments (i.e., Safety, Medical Writing, Clinical, Biostatistics and Quality Management) to ensure that their requirements are satisfactorily fulfilled.- Evaluates groups' project progress and recommends changes in procedures and objectives.- Assists in departmental and clinical budgetary activities.- Represents groups in providing solutions to technical problems.- Coordinates validation of all analyses generated by Analysis Programming Group.- Provides mentoring, on-the-job training, and supervision of new contractors.
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This individual will report into the market access function, but work cross-functionally with sales, brand, trade, business analytics and commercial partners to drive strategic decisions and tactical programs that provide customer value for payers across therapeutic categories and over the lifecycle of products. The development of promotional and educational materials to support the field account executives, and other field personnel is a key deliverable for this function. This position will be responsible for building channel and brand payer strategies, collaborate on creating the value proposition and evidence generation strategy for US payers, segmenting payers, creating personal and non-personal tactics, and managing the related budgets. Additionally, providing insight into strategic pricing plans will be a component of this position. The Assoc Director may also lead strategic market monitoring and expansion projects. The Associate Director in this role must have hands-on payer marketing experience developing winning strategies that drive value and access in complex payer markets. This includes an in-depth-knowledge of payer customer environment, buy-and-bill systems, and an understanding of the evolving reimbursement landscape. They must have worked in a payer marketing role or had relevant experiences that demonstrate strategic thinking, driving results and customer orientation.7-10 years in the pharmaceutical industry with the majority of time in managed markets and marketing.• Understand and educate the organization on market access landscape, channels, and strategieso Develop channel and brand specific marketing strategies and associated tactics to support corporate and brand objectives and execution requirements through all resourced Market Access Field teams.o Develop pull through strategies aligned to market access and brand objectiveso Direct brand specific Market Access market research activitieso Lead market expansion opportunity projects• Lead cross functional market access strategy team to deliver an integrated market access strategy for the corporation while aligning to customer value with each engagemento Develop and maintain value message platform for brando Direct and create the necessary promotional tools that support Account Executive efforts with key customers and pull through of payer opportunities in the field with customerso Manages key Agencies of Record to deliver tools and tactics• Lead budget planning process for Market Access and Manage Market Access Marketing Brand budget resources• Engage and inform commercial partners
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The Senior Product Manager will be responsible for contributing to the strategic development and overseeing tactical implementation of marketing programs designed to drive brand awareness, increase adoption and contribute to the achievement of business objectives for an assigned product in the CNS arena.This position will report to the US HCP Marketing lead. The position requires a highly motivated individual that can work efficiently with cross function partners to ensure strategic alignment and accomplish complex deliverables (i.e. lead brand planning, sample optimization, POA development, brand communications, etc.)• Plan, identify, create and produce HCP promotional materials, programs, and activities needed to support brand strategies to meet business objectives. • Collaborate with alliance and agency partners in the execution of HCP strategic and tactical plans o Agency management – Work with the AOR to develop and deliver all of the tactical elements of the promotional mix • Serve as brand to the field sales teams to drive effective communication of brand priorities and seek feedback to improve marketing tactics• Work with cross-functional team to develop, coordinate, and execute Field Sales Plan of Action (POA) meetings. • Work with market research and analytics to identify and implement metrics to gain market insights and measure performance on brand initiatives and programs.• Effectively drive tactics through the Medical, Legal, and Regulatory approval process.• Monitor products, marketplace, and competitor trends and issues to anticipate/identify threats and opportunities. Make recommendations and develops tactics to respond to threats and opportunities.
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The Submission Specialist, under minimal supervision, will assume the responsibility of reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies, business partners, affiliates and other destinations. Submission specialist will perform the reconciliation of submission dates and assist with site audit requests. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting.As a member of the Drug Safety and Pharmacovigilance department, the Global PV Workflow Sr. Associate is responsible for participating in the collection, safety review, processing and reporting of adverse event data in compliance with applicable FDA and global regulations. The Global PV Workflow Sr. Associate will ensure the uniform and timely processing and reporting of adverse events to regulatory authorities and business partners in collaboration with Drug Safety Operations team members. Global PV Workflow Sr. Associate will participate in the set-up and development of monitoring tools and maintenance of adverse event workflows within Avisso to meet global regulatory reporting requirements. In addition, the Global PV Workflow Sr. Associate will assist with the case readiness for internal and external reports (PSURs, PADERs, etc.). The Global PV Workflow Sr. Associate, will coordinate and monitor the department’s workflow, and assist in special projects as assigned. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting. - Coordinate Safety Operations workflow to ensure timely processing and reporting of adverse events to regulatory authorities and business partners- Generate and use established reports to monitor daily case workload and reports due, working with team members to identify potential bottle necks or resource gaps and coordinate work plans accordingly- Generate and use established reports to monitor action items, reports worklist and additional worklist as needed.- Participate in the set-up and maintenance of adverse event workflow processes, department policies, and standard operating procedures- Assist in the ensuring ICSR readiness for inclusion in individual and aggregate reports (PSURs, PADERs, etc.) - Process adverse event information received by the Drug Safety and Pharmacovigilance department and assist in the preparation of internal and external reports- Review adverse event information received for completeness and consistency, initiate case follow-up activities/AE query management, and independently generate narratives in accordance with department processes- May perform quality control activities to ensure complete and accurate case information has been entered into the drug safety database- Follow company processes and guidelines for case management and closure activities, and adhere to company templates and guidelines for documentation and communications- Ensure compliance with corporate and departmental standard operating procedures Contributes to development of standardized practices, procedures, metrics and measures productivity and performance within PV Operations.- May assist in the preparation of ICSR health authority responses - May manage department staff- May distribute completed regulatory reports - May provide support and back-up to the submission function- Perform other activities as directed by Drug Safety and Pharmacovigilance management- - Drafts safety summaries for inclusion in medical information write-ups, including analysis of similar events in alert reports- Supports the generation of Aggregated Safety Reports (e.g. EU Annual Safety Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks- Provides training on the technical and operational aspects of programs to GPV team members (and other OPDC staff as appropriate).- Communicates product safety issues to team members in a timely manner.- Utilizes regulatory and GCP knowledge to assist team members in the assessment of adverse event reports- Represents GPV at interdepartmental team meetings- Represents GPV at meetings conducted with licensing partners, agents, CROs, and clinical site investigators- Interacts on a regular basis with contract drug safety vendor (data management, case processing, call center, etc) to resolve safety-related issues- Reviews and provides input on protocols, case report forms, investigator brochures, package inserts, and NDA/PLA documentsContributes to presentations, discussions, and data summaries on safety issues at meetings with external groups such as licensing partners, agents, contract research organizations, independent safety monitoring committees, and clinical site investigators
