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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; Be responsible for the development of promotional and educational materials to support the field account managers, and other field personnel is a key deliverable for this function. Creating personal and non-personal tactics, managing the related budgets. The Assoc Director may also responsible for developing and executing expansion projects. The purpose will be to undercover insights that result in expansion, experiments and pilots that could expand business opportunities in these channels.The Sr. Manager in this role would preferably have payer marketing experience developing winning pull-through strategies that drive performance in payer markets. This includes an in-depth-knowledge of payer customer environment, and an understanding of the evolving reimbursement landscape. They must have demonstrated strategic thinking, driving results and customer orientation.5 years in the pharmaceutical industry with the majority of time in managed markets and marketing.Additional Responsibilities: • Understand and educate the organization on market access landscape, channels, and strategieso Develop Channel and Brand specific marketing & execution strategies and associated tactics to support brand objectives and execution requirements thru all resourced Market Access Field teams.o Develop pull through strategies aligned to market access and brand objectiveso Support Brand specific Market Access Market research activities.o Support Market expansion opportunity projects• collaborate 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 market access messaging platform for Brand.o Direct and create the necessary promotional tools that support the Sales Force efforts with key opportunities and pull through of payer opportunities in the field with customerso Manages key Agencies of Record to deliver tools and tactics• Manage budget planning process for Market Access Brand budget resources.• Engages and informs commercial partners.
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The Head of Medical and Real World Data (RWD) Analytics in the Data & Analytics (D&A) is accountable to the scientific and strategic delivery of Otsuka’s Medical Affairs and Value & Real World Evidence (RWE) portfolio goals in partnership with their leaders. This role will drive the goals for Medical Affairs and RWD with responsibilities of generating clinically meaningful, value-based evidence for the R&D and the Commercial organizations. This is inclusive of supporting label enhancing research as well as optimizing trial operations with RWD and enable data-driven investments in clinical studies to gain approval for new indications and/or product approvals. To do such, the function will provide the R&D and Commercial organizations data and analytics supporting registrational (e.g. synthetic control arms, epidemiological studies, etc.) and post-approval domains (e.g. Market Access, and Value Based Contracting). This role oversees a cross-functional team of biostatisticians, data scientists and programmers and will lead these essential capabilities in an integrated manner and partners closely with the Clinical Analytics team. Reporting to the Chief Data & Analytics Officer (CDAO), and a member of the D&A Leadership Team, this leader will become a driving force of change and delivery across the Data & Analytics organization.- Provide leadership, oversight and technical/scientific direction to the Medical & RWD Analytics organization. A high functioning Medical & RWD organization would be expected to deliver on both, strong scientific engagement and operational excellence. Specific areas of focus would be inclusive but not limited to the following: efficient and effective design of RWE generating studies, analysis planning, publication support, propagating RWD use across the development and commercial life-cycle as well as the identification and leveraging of existing industry RWD.- In support of the Medical Affairs and Value & RWE strategies, this role will provide scientific and strategic review of materials, inclusive of but not limited to RWE generating protocols, analysis plans, publication materials, etc.- Operational excellence would be demonstrated through the effective and efficient delivery of the Medical & RWD portfolio and ensuring portfolio prioritization is consistent with the enterprise imperatives. This includes but is not limited to the resourcing, prioritization, timeline management, functional outsourcing, etc.- Participates in Medical Affairs and Value & RWE portfolio governance and provides insights and strategic direction based on scientific principles, industry practices/precedence and competitive considerations.- Contributes to D&A departmental governance reviews of portfolio and prioritization discussions. Regular monitoring and reporting on the operational health of Medical & RWD Analytics, through the use of scorecard and metrics reflecting the functional performance of financials, quality and cycle-time.- Develop and lead the digital strategy for RWD that is generated through traditional data capture mechanisms as well as through digital mechanisms (e.g. mHealth).- Function as a knowledge base and resource to project teams. Serves as a point of escalation and resolution for the Medical & RWD Analytics organization and portfolio.- Models and coaches scientific engagement best practices that enable thought partnership and engender a collaborative environment with healthy debate.- Fosters a culture that focuses on the achievement of goals and personal accountability, through the setting of objectives and expectations, monitoring to plan, the redirection as needed and the celebration of achievements.- Fosters a culture that embraces the strategic use of data into decision making through the demonstration of the value data can provide with essential direction enabling greater business outcomes.- Builds a learning culture within and external to Medical & RWD Analytics, where individuals are provided growth and development opportunities. Drive broad knowledge sharing activities through the use of external expert lectures and trainings as well as internal sharing activities.- Accountable for ensuring collaborations and communications with key stakeholders of Medical & RWD Analytics.- Attract, retain, develop and promote talent to build a team with an optimal balance of experience and diverse perspectives.- As a member of the D&A Leadership Team, models the balance of innovation and intellectual curiosity with discipline and structure. Is a champion of value-add change and evolution and is able to inspire and motivate others.
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Associate Director Clinical Quality Assurance is responsible for internal and external Clinical QA & QM Activities to support Clinical quality assurance program and quality systems. This includes QA review of clinical trial documents, data integrity assurance, GCP compliance at clinical sites and internally, clinical vendor (CRO) audit, CRO qualification and management, internal and external GCP quality audits, Inspection readiness and supporting clinical CAPA resolutions and effectiveness. This position is critical to clinical quality assurance activities internally at Otsuka and ensure documentation is appropriate, and critical service providers such as CROs, test labs and clinical sites are compliant to GCP. Primary function of this position is to provide the daily hands on support to the Clinical Quality team and Clinical organization with respect to Otsuka clinical QA and external facing Quality assurance, clinical compliance, clinical quality assurance and clinical vendor management and control. Key responsibilities of this function include management and control of activities at key vendors like the CROs, biometrics and data management vendor, Safety database vendor, labeling and distribution etc. These subsystems need substantial sponsor oversight during the formative stages. This function will also support phase II requirements such as PAI inspection preparation, readiness and quality representation. This position will participate on clinical process improvement projects and initiatives, supporting departmental and corporate quality goals and priorities, while ensuring products, processes and systems effectively meet expectations of Otsuka Global Clinical Quality Assurance and Overall Business from a clinical development GCP compliance perspective from concept through commercialization. The successful candidate will be a seasoned professional with experience in clinical quality assurance, clinical research management, data management and clinical quality assurance function in a clinical stage pharmaceutical or combination product organization. Advisory: GCP QA will provide advice on the interpretation and application of the regulatory requirements. Provide Clinical researchers advice in resolving non-compliance issues in a professional and pragmatic way. This individual will be responsible for both auditing and providing guidance on GCP. The individual also acts as a GCP quality adviser to the functions involved in the drug development process and providing ‘trouble-shooting’ advice and interpretation of regulations and guidelines. Addressing Clinical Quality events and Driving robust Clinical Functional Area partnership and engagement for High Quality Culture Support internal and external organizations: The GCP QA professional will identify areas for improvement and update procedures and policies related to GCP practices. Interact with different groups within the organization and outside including clinical research, outsourcing/contracts, IT, data management and biostatistics, clinical trial supplies, pharmacovigilance, regulatory affairs, SOP management groups and training functions. Externally, GCP QA professional will interact with a diverse range of groups such as third-party service providers, CRAs, Investigators, Study Nurses and other study site personnel, and in the event of inspections the regulatory inspectors. Auditing and Report Writing: The type of audits that may be conducted includes: Third party service providers; Clinical trial sites; Quality Systems audits; Documentation audits; Computerized systems; Inspection preparation. This position provides the essential, hands-on day-to-day support to the organization, specifically to the Otsuka Global Quality management in CRO management, internal GCP compliance and preparation of key activities leading to PAI inspections, Sponsor and Clinical Site Inspection Hosting and training , Inspection Readiness preparations oversight and control to ensure PAI Inspection readiness, vendor oversight management, vendor investigation, deviations and CAPA. - Perform diagnostic and descriptive analytics to identify performance trends, root cause assessments and identify areas of continuous improvement- Participates on clinical project teams and influence and encourage clinical teams towards a state of inspection readiness at all times.- Consultant support for compliance and regulation questions including quality review of clinical study documents- Participates on clinical process improvement projects and initiatives, supporting departmental, divisional, and corporate quality goals and priorities.- Facilitate Inspection Readiness program to include inspection readiness training and facilitate/coordinate Mock BIMO inspections.- Manage/coordinate BIMO sponsor inspection, and other regulatory agency sponsor inspections of offices.- Preparation of investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings.- Communicate with global clinical teams and Strategic Sourcing regarding new clinical vendor requests, current clinical vendor needs, and future needs.- Clinical Quality System: Support to the Clinical organization in meeting- Quality system requirements: Support Clinical and QS team during External Regulatory/Notified Body audits.- CAPA program; assessing internal noncompliance working cooperatively with CAPA owners providing quality input.- Independent Auditing: Plans, schedules, and conducts external quality audits to assure that clinical investigations comply with all applicable regulatory requirements and BSC policies and procedures.- Plans, schedules, and conducts internal quality assurance audits of the systems, procedures, and controls employed in the design, conduct, and analysis of clinical trials.- Plans schedules and conducts clinical vendor assessments, qualification and periodic. Review, revise, update and maintain Clinical AVL- Communicates observations to clinical investigators, clinical program managers, directors, and management.- Contributes to the development of audit procedures and processes.- Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes.
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Director, Global Clinical Quality (GCQ) Quality reports to the Senior Director of Global Quality Management and will be responsible for ensuring compliance with Good Clinical Practice (GCP) / Good Manufacturing Practices (GMP) and established guidelines for regulatory standards for clinical studies, as well as company policies/procedures. This position is the key contact for internal business partners as well as CRO and clicinal sites for the developent, execution, and inspection readiness of global clinical studies.
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The Associate Director, CNS Consumer Marketing will be responsible for developing the Consumer marketing efforts for a flagship CNS product. This person will be responsible for the day-to-day development and delivery of all key brand deliverables and materials (TV, Print, Digital, Field) to appropriately market the product to consumers. Core responsibility is leading existing and future marketing tactical development for a multi-channel DTC campaign with cross-functional teams to ensure successful execution of strategies and tactics leading to brand growth and strong ROI. This individual will develop a customized Consumer strategy and manage multiple agencies to drive completion of projects and associated communications on-time and on-budget. This individual will be instrumental in partnering with creative and media agencies, metrics partners, market research, finance, IT, and regulatory teams, and will bring a high degree of ownership to the implementation of the consumer campaign and strategies.This individual will bring market expertise by generating additional ideas and strategies to reach consumers in innovative ways, including digital marketing. Problem-solving skills, an innovative mindset and a desire to look deeply for patient insights are essential for success in this role. Position reports to the Brand Lead, CNS Marketing. The Associate Director, Consumer Marketing has responsibilities including, but not limited to: - Development of Consumer Marketing strategy and tactics for the BP-I and SZ indications:- Development of a customized Consumer Marketing Plan - DTC strategy development (across different media channels)- Creative/Message evolution- o Patient education and in-office/in-clinic programs o Copay card messaging and design developmento Partners with Customer Insight and Business Analysis groups in refining market research planso Evaluate and fine tune standardized, aligned performance metrics
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Within Otsuka Pharmaceutical Co. exists Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) a U.S.A. subsidiary exists the Global Clinical Development (GCD) department. OPDC-GCD are a group of physicians and scientists who lead clinical development activities for Otsuka’s global health-care products. Our team is collaborative, innovative with a mantra of “acting as though the company was our own.” Our responsibilities range from due-diligence evaluations, where we stress-test others’ development plans, to development and implementation of our own global development & commercialization plans (GDCP). The GDCP translates basic research and preclinical pharmacology & toxicology into a streamlined plan for first in man, proof of mechanism, registrational and post-approval trials. Its goal is to efficiently evaluate the product’s potential and probability of success, support an effective commercial launch and plan for meaningful innovations to improve or expand the value of the initial product for our global customers (patients, prescribers and payors).Detailed Description of Duties:Otsuka is seeking an Associate Director/Director, Global Clinical Development based in 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 practices (GCP). The incumbent will be responsible for the evaluation and clinical development of CNS and Digital Medicine products at different stages of development for a global health-care market.The specific duties assigned to the Associate Director/Director, Global Clinical Development include the following:- Consults with patients or their representatives, clinical, regulatory and scientific leaders and thoughtfully applies their recommendations toward optimizing trial objectives, designs and protocols.- Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other research project team members, and to external regulatory agencies.- Authors program strategies (i.e., GDCP) and oversees trials essential for determining the clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates.- Interprets and communicates results of Phase I-IV investigations in preparation for a new drug.- Acts as the signatory on NDA submissions and clinical study and safety documents.- Involved in product life cycle management from the earliest stages of development, constantly seeking innovations to add value strategically.- Provides strategic oversight in our vendor and CRO relationships, and provides clinical input into their governance committees.- Will help lead and support regulatory filing activities and documents. Providing strategic direction and editing to provide concise, clear and convincing argumentation in all such written and verbal communications.
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DELIVER A MARKETING EXPERIENCE THAT IS MEASURABLE, CREATIVE & CLEAR Otsuka-people create new products for better health worldwide. We are seeking an experienced Strategic Corporate Marketing professional who wants to make a difference in the world. Join Otsuka’s mission to help raise awareness around mental health, serve as a catalyst for healthcare innovation and immerse yourself in an engaging culture. We will count on you to strengthen Otsuka’s brand equity and customer engagement, create memorable campaigns and develop long-term goals that will help increase our community reach. Develop high impact messages internally and externally. Work with lots of incredibly talented peers. Don’t just think outside the box, live there. Bring your best and brightest ideas to help shape industry conversations and create a movement in healthcare worldwide. Are you a creative and unconventional thinker, with a strong ability to work independently in a fast-paced environment who is passionate about brand story-telling and willing to challenge the status quo? Otsuka is seeking a savvy Marketing expert who can deliver positive outcomes on corporate and brand initiatives. Our Corporate Marketing lead will work collaboratively with executives, business stakeholders, alliances, and key influencers to increase Otsuka’s brand awareness, differentiate our company and products in the industry, and position Otsuka as a thought leader. Key Job Responsibilities:- Lead corporate-level brand platform and strategic marketing efforts- Develop long-term growth strategies and national corporate brand campaigns with internal and external stakeholders and agencies- Build, manage and execute effective and strategic marketing plans in a fast-paced environment- Generate effective communications and alignment in a heavy consensus style environment- Bring the Otsuka story to life- Develop and maintain strong and strategic executive and client relationships- Advise clients on campaign strategies and message development - Guide thought leadership efforts and positioning for internal and external events- Scale corporate marketing solutions across both paid and owned media- Drive strategy and messaging framework for marketing materials, website, blog and other social platforms- Manage complex projects and identify interdependencies across the organization- Develop segmented messages and supporting materials i.e. FAQs, infographics, videos, etc., with the extended Corp Communications team- Develop robust plans that integrate PR, digital and social media. - Leverage corporate market insights and drive maximum growth based on research, analysis and pilot programs- Monitor, analyze and communicate corporate marketing initiatives and respective team results on a quarterly basis - Demonstrate an increase in public awareness of the organization and/or products. Maintain a keen understanding of industry trends affecting the pharmaceutical and digital industry and make appropriate recommendations- Manage the digital and social media teams and serve as a coach to assist in career development and growth- Learn to lead the Otsuka Way- Build relationships with thought leaders, advocacy groups and local/national organizations as needed to grow industry awareness- Liaise with agencies including managing relationship, work efficiency, budget, and project management
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Otsuka is looking for an energetic, motivated, talented individual to join the Bioanalytical team with experimental design experience in either drug development or molecular biology. In addition to regulated bioanalysis, innovative measurement projects, that focus on clinical trial outcomes and process improvement, such as biomarker analysis, microsampling for PK sample collection, and genetic variant correlation with clinical endpoints are just a part of what we invest our energy in. If you are looking for an opportunity to pioneer the field of biological measurement, look no further.The Bioanalytical team is responsible for managing the outsourced measurement in biological fluids to support clinical drug development, with focus on drug concentrations and their metabolites and pharmacogenomics in support of PK assessments. In addition, responsibilities include research design for exploratory genomics and other -omics technologies, as well as emerging technology for the assessment of mechanism of action and biomarker identification. The Associate Director, Bioanalytical and Biomarkers will have proficient knowledge in global bioanalytical guidance regulations and understanding of how bioanalytical data flows from the laboratory to regulatory submissions. Strong analytical experience, particularly HPLC-MS/MS and genomics platforms, cell-based technologies, such as flow cytometry, as well as experience with vendor management is strongly preferred. The individual will be responsible for managing vendors who generate bioanalytical data and ensuring data is auditable, submission-ready and of high quality. He/she will contribute to method development problem solving and support data-driven projects, such as biospecimen management. In addition, he/she will be responsible for surveying the clinical trial measurement landscape and make recommendations on process and technological improvements. The individual should maintain awareness of evolving trends in analytical techniques to support clinical trials and defend innovation projects to the project teams. He/She must have excellent verbal and written communication skills, strong organizational skills, and be able to manage multiple projects in different stages of development under strict deadlines and fluctuating priorities.Limited travel is required.
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This position is responsible for the identification and acquisition of data assets in support of business objectives. This includes supporting data valuation and assessment of new and existing third-party data sources, with strong emphasis on ensuring data quality, completeness, integrity, compliance and availability in accordance with business information needs, and industry best practices for the efficient and cost-effective management of data assets and data vendors.Reporting to the Information Stewardship function are under the CDO, the scope of responsibility for this role spans all Otsuka third-party data source assets with a focus on the Commercial data assets and opportunity to expand to other third-party data assets. Beyond data stewardship, responsibilities also include data vendor negotiation, contracting, and managing to expectations through performance indicators. Acting as an SME for third-party data, this role will contribute to business initiatives with a comprehensive understanding of commercial data sources and their utilization internally and across industry. The role enables fact based, actionable decision making through acquisitions of critical data assets, and contributing to broader commercial data information governance & operations efforts.The position requires expertise in commercial ta identification, acquisition and management in the pharmaceutical industry This expertise would include strong business acumen and knowledge of pharmaceutical commercial data sources and practices, commercial data governance & operations, commercial business processes and data management tools and methodologies. In addition, the position also requires the ability to interact and collaborate with a variety of internal departments, brand marketing, sales and marketing operations, business analytics, market intelligence, trade affairs, digital medicine, information technology, legal & compliance, co-promotion partners, as well as data and data service providers across the matrix.• Establishes, builds, and strengthens relationships with key commercial stakeholders to ensure ongoing commercial data acquisition needs are met expediently and satisfactory. Identifies full-range of commercial data needed to perform decision support analysis and reporting across business areas. Maintains commercial data acquisition and utilization requirements on an ongoing basis.• Maintains relationship with data providers, data service vendors, commercial partners and informs leadership of emerging data sourcing needs and opportunities. Seeks opportunities to derive more business value from primary and secondary data sources and proactively scouts for new commercially available data assets, new data services and enhancements to data offerings from current data vendors to enrich existing capabilities. Stays abreast of current trends, start-ups, and novel data sources to inform future partnerships.• Works with Strategic Sourcing and Business Sponsors to develop and negotiate contracts with data vendors in support of the data strategy for specific brands or business functions. Ensures appropriate data clauses are implemented in contractual agreements to meet overall business objectives, mitigate risks (inclusive of privacy and security considerations), manage costs and achieve expected service levels. Conducts schedule data vendor reviews in cooperation with business sponsors, IT and Strategic Sourcing. Acts as liaison on matters of bids, pricing, TPAs, etc. Oversees and where possible, coordinates purchases of data across business functions, affiliates, co-promoters and partners.• Works closely with commercial stakeholders, Information Governance, IT, and data vendors (e.g. specialty pharmacies, GPOs, data aggregators, marketing and digital agencies, etc.) in defining and operationalizing source data QA/QC procedures, cadences and flows. Leads the definition of business rules to address incomplete or incorrect third-party source data to ensure appropriate data integrity and cleanliness. Defines, creates and delivers data quality metrics, statistics and status reports regarding the business content and integrity of sourced data.• Serves as a point of contact to Business and provides input and guidance on third-party source data strategy and policies related to commercial data sourcing, standardization, enhancement, and maintenance. Informs on data scouting and new data acquisition plans, initiatives, budgets and data vendor review metrics and results.• Plans, executes and evaluates source data related change management activities including communications and training. Allocates and manages change management resources, prepares training materials and data for source data related training, maintains source data documentation and user manuals. Authors’ communications for enhancements, changes, best practices and FAQ’s. Engages downstream channel owners to understand usage of source data and get buy-in on accurate and effective data utilization. Leads operational meetings for third-party data vendors according to predefined cadences and business needs.• Serves as a project leader for commercial data identification and acquisition initiatives to ensures data assets are onboarded and available within the required timelines, within budget and in accordance to predefined dependencies (e.g. business planning cycles, strategic initiatives, technology enablement project phases, etc.) Assist with the planning and implementation of data management solutions and systems.• Provides expertise and guidance in data management processes and data lifecycle management. Translate business needs into business requirements for IT to implement. Provides input on the structural quality and integrity of source data entities and elements using data architecture concepts and supports enterprise data architecture initiatives to ensure that entities and elements are designed according to Otsuka’s data standards.• Supports efforts and initiatives associated with the integration of sourced data into commercial data lakes/warehouses/marts. Supports the administration and maintenance of information libraries, data dictionaries and other data management tools.• Supports data management and IT organizations on periodic reviews and audits on the data infrastructure and data models for core commercial data repositories. Reviews requests initiated by Business Process Owners for new strategic data entities and elements to determine if an existing definition can be used. Provides guidance to business process and system owners on performing source data impact analysis and investigations.
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The Market Research Manager role supporting the Central Nervous System (CNS) businesses at Otsuka Pharmaceuticals supports the commercial insights needs for inline brands and early development assets. The MR Manager will be responsible for market research, competitive intelligence and other commercial research for Otsuka’s portfolio of brands and assets indicated to treat patients living with mental health conditions. The role will support one or more CNS brands and Life Cycle Management (LCM) opportunities. The role reports to the Market Research Director for CNS and will work day-to-day with business analytics and insights personnel. The Manager is expected to conduct insightful and actionable market research that will have a positive impact on brand performance and inform decision making for marketing and sales. Key stakeholders for the CNS MR Manager include the respective Brand Teams and Commercial Operations.The MR Manager is responsible for the design, execution, and management of market research projects. In addition, the MR Manager is expected to commission and partner with MR agencies for primary and secondary research in the US and international markets, as needed. The position requires proficiency in business analytics as well as leadership and collaboration with marketing and sales partners. The person in this position will be part of the Business Analytics & Insights organization and work directly with the CNS brand team. Knowledge and Skills Requirements:• Self-starter that will proactively take ownership of building internal relationships and learning the Otsuka culture• Comfortable working in a dynamic and fast-paced environment• Proven track record of applying market research insights to positively influence brand performance• Oversee and deliver qualitative and quantitative primary market research• Experience working with secondary market research data, including prescription data, patient-level data, sales data, and payer data• Proven experience and expertise integrating primary and secondary data into synthesized information and insights• Ability to develop and leverage new market research tools and process to drive deeper insights• Lead special projects as required by the needs of the business• Represent the function in various business meetings• Working knowledge of the clinical development process and product life-cycle from early stage through product launch, maturity and loss of exclusivity.• Strong, game-changing analytical abilities and insights generation skills• Strong interpersonal and communication skills• Ability to collaborate with marketing/sales partners and to influence decision making• Experience managing and developing vendor relations so that the agency can best contribute to Otsuka’s future success• Strong team player with good leadership skills
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The Director of Market Research role for Nephrology and Digital Medicine is a leadership position designed to support the customer & market information/insights needs of the Global and US Nephrology and Digital Medicine Brand Teams. The position is responsible for leading the market research, competitive intelligence, and select business analytics for Otsuka America Pharmaceuticals Incorporated (OAPI) and reports into the Senior Director of Business Analytics & Insights. The MR Director will lead the market research for Otsuka’s Nephrology & Digital Medicine inline brands, Jynarque and Abilify MyCite, and for other Nephrology & Digital Medicine assets in early development (e.g., Vadadustat, IGA Nephropathy assets, Lupus Nephritis assets, and other Digital Medicine products).The Director of Market Research is expected to function as a team leader and contribute to the design and implementation of actionable market research that influences business decisions that add value and that drive brand performance. There is currently one MR position reporting into the Director of Nephrology & Digital Medicine MR, with opportunity to grow the team as the portfolio increases and early development assets move closer to launch. The primary stakeholder for the Nephrology & Digital Medicine MR Director is the OAPI Nephrology and Digital Medicine Business Units.The Nephrology & Digital Medicine MR Director is expected to work with the MR team to lead the design, execution, and management of market research projects. Additionally, the MR Director is expected to select, manage, and communicate with MR agency partners for primary and secondary market research projects across US and International markets. The position also requires competency in business analytics and competitive intelligence, as well as leadership and collaboration with marketing and sales partners. The MR Director is part of the Business Analytics &Insights organization which is one of several functions in the Commercial Operations Department. The MR Director will interact with OAPI senior management and will serve as the primary MR point person for the Nephrology and Digital Medicine Business Units. Knowledge and Skills Required:• Autonomous and entrepreneurial approach to leading MR projects and teams• Demonstrated excellence in executing MR projects, managing agency partners and leading teams• Broad and deep knowledge of both qualitative and quantitative MR tools and techniques• Demonstrated competency in going beyond market research results and providing deep customer insights that drive business success• Proven track record of applying cutting-edge market research tools and techniques to positively influence business decision making and brand performance• Demonstrated experience and expertise integrating primary and secondary data into synthesized information and insights• Unwavering commitment to teamwork and collaboration within and across functions• Proactively takes ownership of building internal relationships with colleagues and mastering cultural standards• Exceptional interpersonal and communication skills, including active listening• Demonstrated ability to collaborate effectively with marketing/sales partners and to influence decision making• Experience and confidence working with, challenging and influencing senior management• Adept at working in a dynamic and fast-paced environment• Strong analytical skills and insights generation expertise• Knowledge of and experience working with secondary data, including prescription data, patient-level data, sales data, and payer data• Ability to think creatively and innovatively in solving complex business problems and to apply solutions to drive actionable results.• Represent the MR function and associated interests in various business meetings and forums• Proven knowledge of the clinical development process and product life-cycle from early stage through product launch, maturity and loss of exclusivity.• Affinity for scientific information as well as working knowledge of medical terminology• Knowledge of and experience managing international market research programs• Experience selecting, managing and developing MR agencies to become trusted business partners; to provide exceptional insights; and to communicate clear and cogent stories that drive business value
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The Financial Planning & Analytics (FP&A) Business Partner is a manager level position that understands Otsuka’s business strategy and provides financial planning and analytics solutions for Otsuka’s Research and Development (R&D) business. This role acts as a finance business partner for development projects and/or functions, including developing and managing budgets, reviewing and supporting forecasting, providing framework and analytics for investment privatizations, providing day-to-day support and strategic analysis for short and long term investment decisions to drive the growth and success of R&D.The successful FP&A Business Partner acts as a champion for the business, monitoring the effect of business decisions on Otsuka’s financials and advises senior management appropriately. This individual is not afraid to challenge the status quo. He/she will deliver innovative financial management strategies that yield strategic competitive advantage to Otsuka. Must be able to assesses and anticipate client needs and identify new opportunities for the R&D Finance function to enhance sustained value. The successful person is learning agile and able to deal with ambiguity, translating complex issues into clear and coherent solutions.- Coordinate, develop, and analyze all activities in the preparation and delivery of the annual budget and forecasts, with limited supervision. As part of a matrix organization, this involves working independently with clinical functional areas and clinical project teams, as well as building relationships with financial counterparts at CRO's.- Actively participate with therapeutic team members to provide financial guidance for all aspects of assigned protocols.- Ability to develop insightful and influential forward looking direction, to develop key scenarios, and to identify key risks/uncertainties and plans for potential mitigation.- Provides financial analyses tools to measure and prioritize investment decisions- Identifies areas of opportunity for spending efficiencies- Incorporates and shares Financial Stewardship principles across R&D- Manages accrual and accounting process across the business- Ensures data integrity and delivery of financial reporting, including summarizing all types of expenses and provides input and analysis on key expense trends and metrics. Focus on process enhancements and continuous improvement.
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The Associate Director of Medical Writing combines elements of both leadership and documentauthoring contributorship to further medical writing activities across OPDC. He/She willparticipate in the implementation of medical writing operational plans and development ofinnovative solutions for medical writing activities across OPDC. He/she will work withoutsourced medical writing teams to ensure delivery of high-quality regulatory writing services inaccordance with applicable regulatory regulations. He/she will ensure communications arecomplete, well organized and scientifically accurate, and that messaging is consistentthroughout all technical documentation. He/she will apply knowledge and makerecommendations of best practices to maximize the value of medical writing services.Additional responsibilities include developing and managing interpersonal relationships bothwithin and outside of OPDC. The Associate Director, Medical Writing will manage processesintended to increase project efficiency, quality and the timely achievement of deliverables andensure the needs of business are met, particularly in the preparation of accurate, timely, andmultidisciplinary documents submitted to regulatory agencies worldwide.Key Job Responsibilities- Authors and/or reviews clinical documents with consideration for regulatory, corporate,departmental, and quality standards (documents include but are not limited to protocols, clinicalstudy reports, Investigator’s Brochures [IBs], annual reports, HA briefing packages andresponse documents, and integrated data summary reports).- Contributes to process development/improvement with the OPDC MW management team(including SOPs, WIs and document working groups).- May manage and oversee medical writing activities, ensuring adherence to the medicalwriting strategy and alignment with business needs.- Contributes to therapeutic project teams as a medical writing expert for regulatory submissiondocuments. Acts as a cross-functional liaison both internally and externally to managedocument preparation processes.- Adheres to Medical Writing practices/systems/tools to support OPDC clinical studies in orderto meet company goals and objectives. Assures that standardized practices are implementedand maintained across all therapeutic areas.- Creates and implements project writing plans.- Supervises contract managers and writers, as needed.- Participates in creation and maintenance of model documents (templates) and the Otsukastyle guide.- Focuses on recognizing efficiencies and innovative new solutions identified through processImprovements.- Ensures medical writing activities meet OPDC quality standards and expectations and adhereto applicable Corporate SOPs, WPs, policies, guidelines and regulations.Assesses Industry regulations, guidance’s, and best practices and prepares recommendationsfor adoption by MW staff.
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The Director of Medical Writing is a leadership role that will be responsible for developing and implementing medical writing strategies, operational plans, and innovative solutions for all medical writing activities across OPDC. He/she will lead high performing in-house and outsourced medical writing teams in the delivery of high-quality regulatory writing services in accordance with applicable regulatory regulations. He/she will ensure communications are complete, well organized and scientifically accurate, and that messaging is consistent throughout all technical documentation. He/she will apply knowledge and make recommendations of best practices to maximize the value of medical writing services and establish and / or oversee key contractual and business relationships with outsourced vendors as needed. Additional responsibilities include developing and managing interpersonal relationships to influence decisions of leaders both within and outside of OPDC, directing the operational implementation of the medical writing department responsibilities. The Director, Medical Writing will identify ways to increase project efficiency, quality and the timely achievement of deliverables; monitor consistency across teams in multiple therapeutic areas, and ensure the needs of business are met, particularly in the preparation of accurate, timely, and multidisciplinary documents submitted to regulatory agencies worldwide. He/she will evaluate the need to develop and /or enhance SOPs, business guidances, and work processes. • Proactively manages and oversees medical writing activities across therapeutic areas as appropriate, ensuring adherence to the medical writing strategy and alignment with business needs.• Contributes to therapeutic project teams as the medical writing expert for all regulatory submission documents. Acts as a cross-functional liaison both internally and externally to manage document preparation processes.• Authors/edits regulatory submission documents, or reviews deliverables produced by team with consideration for regulatory, corporate, departmental, and quality standards (documents include but are not limited to clinical study reports, Investigator’s Brochures [IBs], annual reports, briefing packages, and integrated data summary reports).• Manages and provides mentorship of Medical Writing Staff.• Establishes and standardizes Medical Writing practices/systems/tools to support OPDC clinical studies in order to meet company goals and objectives. Assures that standardized practices are implemented and maintained across all therapeutic areas.• Leads medical writing strategy review and development.• Creates and implements project writing plans.• Supervises medical writers, managers, and contract writers as needed. Directs resource planning, budgeting, and restructuring to meet project and organizational needs and objectives.• Oversee creation and maintenance of templates for reports and patient narratives, and style guide.• Focuses on recognizing efficiencies identified through process improvements and implements them.• Engages with internal stakeholders to assess/understand business priorities and ensures medical writing continue deliver value to the business.• Ensures vendors of medical writing activities meet OPDC quality standards and expectations and adhere to applicable Corporate SOPs, WPs, policies, guidelines and regulations. Modify and update SOPs and WPs and supporting processes and documents as appropriate.• Benchmarks with industry peers and across other industries to establish and update best practices medical writing.• Ensure appropriate communication and involvement across functions and therapeutic areas to create clear accountability for high quality, multidisciplinary documents submitted to regulatory agencies worldwide. • Provides training and communications to internal stakeholders and providers regarding medical writing process, best practices and process improvements.• Reviews new ICH and FDA guidelines regarding medical writing, evaluates their impact on the organization and determines if any procedural changes are needed.
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Position SummaryThe Manager, Regulatory Affairs serves as regulatory representative to Project Teams for assigned projects or products and provides regulatory tactical support and strategy. Liaises with regulatory agencies in order to expedite approval of pending registration and answer questions. Ensures that clinical trials meet regulatory requirements as designed. Prepares and ensures rapid and timely submission of new drugs and maintain applications to sustain approved status of marketed drug. Recommends guidance to Project Teams on steps necessary to comply with newly enacted regulations and guidelines.- Recommends regulatory requirements for clinical and pre-clinical submissions to FDA for assigned investigational and marketed products.- Conducts regulatory research and intelligence to appropriately guide Project Teams.Responsible for the overall quality of regulatory submissions. Manages, Reviews and organizes documents intended for submission to FDA to assure compliance with regulatory standards. Provides appropriate regulatory guidance to Project Teams for the development of the above regulatory submissions.Interacts with Project Managers at FDA (pre and post submission). For assigned projects, provides effective oversight for regulatory submissions that are outsourced.
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Position Summary The Associate, Regulatory Affairs assists the regulatory representative to Project Teams for assigned projects or products and by providing regulatory tactical support and strategy under guidance from manager. Ensures that clinical trials meet regulatory requirements as designed. Prepares and ensures rapid and timely submission of new drugs and maintain applications to sustain approved status of marketed drug in conjunction with more senior members of the department. Job ResponsibilitiesAssists Managers, Directors, or Senior Directors of Regulatory Affairs in providing guidance to Project Teams on steps necessary to comply with newly enacted regulations and guidelines.- Under guidance from manager, recommends regulatory requirements for clinical and pre-clinical submissions to FDA for assigned investigational and marketed products.- Conducts regulatory research and intelligence to appropriately guide Project Teams.Assists in ensuring the overall quality of regulatory submissions.- Manages, Reviews and organizes documents intended for submission to FDA to assure compliance with regulatory standards under direction from manager.- Provides appropriate regulatory guidance to Project Teams for the development of the above regulatory submissions.Works on initiatives as a regulatory representative
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Position SummaryThe Senior Regulatory Assoicate assists the regulatory representative to project teams for assigned projects or products and by providing regulatory tactical support and strategy under guidance from manager. Ensures that clinical trials meet regulatory requirements as designed. Prepares and ensures rapid and timely submission of new drugs and maintain applications to sustain approved status of marketed drug in conjunction with more senior members of the department. Job ResponsibilitiesAssists Managers, Directors, or Senior Directors of Regulatory Affairs in providing guidance to Project Teams on steps necessary to comply with newly enacted regulations and guidelines.- Under guidance from manager, recommends regulatory requirements for clinical and pre-clinical submissions to FDA for assigned investigational and marketed products. - Conducts regulatory research and intelligence to appropriately guide Project Teams.Assists in ensuring the overall quality of regulatory submissions.- Manages, Reviews and organizes documents intended for submission to FDA to assure compliance with regulatory standards under direction from manager.- Provides appropriate regulatory guidance to Project Teams for the development of the above regulatory submissions.Works on initiatives as a regulatory representative
