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The Manager, Compensation administers existing compensation programs for US and Canada employees. Provides analytical and technical support for Compensation and Benefits activities throughout the organization including annual process, pay structure creation, salary survey analysis, and related duties. - Conduct analysis on internal and external salary statistics. Based on the information collected, recommend, develop and assist in implementation of an appropriate employee compensation structure.- Identify, participate in and analyze the results of relevant salary surveys- Assists in the analysis, design, and administration of employer compensation programs, including base pay, incentive pay, and performance management programs.- Develop and deliver data, analysis and recommendations to management to support new hire, promotion, and equity recommendations.- Build spreadsheets, analyze market data and perform analysis to support creation of new pay structure and job code system. - Evaluates jobs, determines pay grades, participates in compensation surveys, and performs associated analysis.- Partner with the rest of the human resources team to ensure compensation and bonus programs can compete with other businesses.- Ensure requests for pay adjustments comply with current compensation policy.- Administer annual pay increase and bonus processes- Administer Workday Human Resources Information Systems
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This position will be responsible for leading a Market Access field account management team. This includes overseeing customer facing account management functions for all required payer channels for OAPI brands. This position will have a key role in execution of Market Access strategy as well as ensuring profitable access and contract negotiations. This position will also lead the assessment, development of recommendations and plans and execution against the US Payer market in close collaboration with Field Sales. This applies specifically to National and Regional Payers, Integrated Delivery Networks, VADOD channel and State Medicaid entities. This position will also include strategic participation in preparation for all upcoming launches. The position will report to the Vice President Market Access and will manage a team of Account Executives. The position is field based and requires extensive travel. Key Job ResponsibilitiesDirect and oversee an account management teamServe as the key communication conduit for the account team on home office initiatives and as the key conduit for informing and advising management of key real-time issues and trends from the market access field Serve as the key negotiation strategist for business to business transactions between OAPI and Customer targetsAssist Headquarters team in assessing customer behavioral trends, market conditions, and changes in formulary/medical policy techniques that have immediate and longer-term implications for the businessOversee the development of Account Plans across all payer channelsRecommend the design of Incentive Compensation programs for the Account Management Function in collaboration with Sales Operations Incentive Compensation teamEnsure compliance with all OAPI policies and proceduresCollaborate with the Sales Regional Directors to optimize business performance and/or manage complex business risks and issuesRepresent OAPI to key Payer AssociationsParticipate in development of product and channel specific strategies including contracting and execution. Direct Account Management CRM tool and process in collaboration with Sales Operations staffConduct all activities in compliance with all applicable local, state and federal laws and regulations and company policiesStrategic role in looking at and leading a corporate approach to the emerging entities of Integrated delivery networks and IDNsWithin the new environment provide strategic planning and execution of the direction of the AE teamWork in collaboration with Market Access Marketing in the development of customer facing tools and deliverables
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- Develop and implement the Flexible Contract Workforce strategic roadmap for Otsuka for the next 3-5 years. Partner with Financial Planning, Strategic Sourcing, Vendor Management Organization, Legal Affairs and other areas of the organization to establish a robust Flexible Contract Worker ecosystem.- Engage with Executive and Senior Leadership to advise on and optimize Otsuka’s resource planning relating to Flexible Contract Workers.- Continuously improve Otsuka’s internal Flexible Contract Worker processes. A major emphasis will be on implementing sustainable systems and processes. - Develop and implement best in class contract worker strategies in conjunction with Vendor Management Office, Legal Affairs, Ethics & Compliance, and relevant stakeholders. - Establish a Flexible Contract Workforce Program Management Office (PMO) ensuring that the daily operations are running effectively.- Identify opportunities and implement process/productivity improvement and automation in collaboration with Otsuka’s business and vendors.- Working with Information Technology, recommend opportunities to implement automation efforts via best-in-class technology.
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50%- Coordinates outsourcing activities across assigned clinical development programs.- Meets with project teams to gain an understanding of the scope of work and priorities of the various projects.- Works with study teams to determine overall outsourcing strategy.- Guides project teams through the outsourcing process and gives appropriate suggestions and advice on the best approach / best practices.- Implements defined outsourcing process to develop necessary documents; e.g., SOW template, transfer of obligations chart, payment schedule, kickoff meeting agendas, etc.- Formulates and harmonizes project scopes, plans, strategies, and budgets for assigned studies/programs.- Keeps up to date on outsourcing trends in the pharmaceutical industry in order to better establish financial and performance agreements.- Aids in the evaluation of potential outsourcing vendors (through effective bidding process and capabilities presentations).30% Vendor/Alliance management:- Participates in scheduling, organizing, and facilitating kickoff meetings with vendors.- Participates and/or facilitates team meetings with vendors.- Supports the project teams to assure the quality and timeliness of deliverables through outsourcing.- Monitors and manages relationships with contracted vendors; facilitates the resolution of issues and conflicts.- Supports organizational governance activities with vendors.- Works with Project Teams to ensure outsourced clinical trial activities meet quality standards and expectations and adheres to applicable Corporate SOPs, WPs, policies, guidelines, and regulations.- Modifies and updates SOPs and WPs in supporting processes and documents as requested.- Ensures smooth and effective communication between the vendors and the company.- Facilitates the closure of each study/contract with the vendor, including a mutual assessment of performance.- Conducts business operational assessment of vendors. 20% Vendor selection and contract negotiation:- Guides and participates in the evaluation, selection, and negotiation of contracts for assigned studies/programs.- Manage outsourcing process to engage new and innovative suppliers, structure outsourcing model to adapt new clinical trial model.- Works with Project Managers and Project Teams to develop RFPs.- Works with Project Managers and Project Teams for all operational, scheduling, project budget and cost-saving considerations for assigned studies/programs.- Liaises with project teams to develop the Statement of Work (SOW) for each contract.
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Maintain a project-level perspective on data management issues, activities and deliverables. Oversee the ContractResearch Organization (CRO) and third-party vendor processes involved in developing data collection systems, data cleaning and providing data deliverables conforming to global Otsuka CDISC standards. Provide strategic input into protocol design from a data management perspective. Represent the Data Management Department on project teams and manages flow of data from collection to submission. Work with representatives from all functional areas to develop and maintain consistency, accuracy and quality of data across therapeutic areas.- Works collaboratively with CROs and third-party vendors to design database, define quality specs, and resolve data management-related issues.- Assists in developing and maintaining DM standards and processes for both in-house and CRO studies in accordance with applicable standard operating procedures (SOPs) and GCPs.- Provides consultation, leadership, and expertise to CRO DM and project teams on Data Management functions.- Acts as the Data Management lead for all assigned protocols, including contributing to the development and implementation of project plan.- Ensure standard processes are followed by all CROs for data management activities. Train CRO personnel on current processes.- Uses software applications to monitor and evaluate CRO performance (e.g. query status, data trends, detecting outliers and study progress).- Acts as a resource to the contract staff to identify problems and propose solutions to maintain projects within designated timelines.- Proactively identifies and implements opportunities for process improvements.- Provides expert review and help in the development of CRF/eCRF/eSource design specifications, validation specifications and report design, etc. Works with external service providers to help troubleshoot and resolve problems. - Ensures the consistency of CRF design and coding across studies and programs. - Contributes to protocols, clinical study reports, Investigator Brochures, Statistical Analysis Plans, INDs and other regulatory documents.- Prepares submission ready Electronic Case Report Forms (eCRFs) to support electronic submissions.- Reviews SOW, provides input and ensures consistency across programs for Data Management activities to be outsourced to CROs.- Manages third party vendors’ (e.g., CROs, EDC/eSource, and ancillary) processes, and local/central laboratories on defined data standards, content specifications, and timelines for deliverables.- Communicates and interacts with CRO vendors to ensure that project timelines are met with quality.- Provides status reports on the progress of projects/programs to internal team.- Ensures data management related presentations for Investigator’s meetings adhere to Otsuka requirements.- Provides input in the development of departmental and global SOPs.- Serves as project team member and works closely with biostatistician and programmer to provide quality deliverables.- Other tasks assigned by Associate Director, Director or Sr. Director of Data ManagementTravel (approximately 10-20%)
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The Account Manager is considered to be skilled or advanced in their demonstration of account management capabilities and sales proficiencies. This individual contributor is self-sufficient and able to apply skills successfully in all situations. Specifically the Account Manager will demonstrate ability in the following areas: Local Market Expertise - Ability to collaborate with internal and external partners to gather and validate key trends and dynamics in the market, map account linkages including stakeholders that exhibit direct and indirect influence on customer behavior. Utilize market knowledge to uncover and prioritize unique opportunities that will allow for mutual value between Otsuka and our customers Reimbursement - Consistently demonstrates the ability to stay informed on reimbursement dynamics, anticipate and communicate impact on product portfolio to key internal and external partners and problem solve payer access issues (Medicare, Medicaid, Commercial) through the use of Otsuka resources Business Planning and Execution - Ability to prioritize opportunities, develop strategy & tactics,, allocate resources, monitor progress and adjust direction in an effort to maximize sales performance and measure progress against plan Critical Thinking - Ability to understand a situation, issue, or problem by breaking it into smaller components. Ability to collect information, derive inferences, find solutions and make informed decisions and recommendations using data and tools where appropriate Pharmaceutical Environment - Ability to apply knowledge of pharmaceutical and regulatory environment, including Otsuka policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply knowledge of overall healthcare economy and industry practices Therapeutic Area Knowledge - Ability to apply therapeutic area knowledge to the sale of Otsuka’s products and/or to increase effectiveness in role Customer Development - Build and maintain productive internal and external relationships (e.g. customers, account contacts, stakeholders and influencers e, etc) based on customer needs and organizational goals Selling - Understand the core selling process, adapt style, and effectively negotiate to bring value to the customer and close the sale Key Job Responsibilities: Drive for Results -Can be counted on to exceed goals successfully, is constantly and consistently able to develop top performing teams, very bottom-line oriented, steadfastly pushes self and others for results. Peer Relationships - Can quickly find common ground and solve problems for the good of all, can represent his/her own interests and yet be fair to others, can solve problems with peers, direct reports and matrix team members with a minimum of noise, is seen as a team player and is cooperative, easily gains trust and support of colleagues, encourages collaboration. Critical Thinking Establish standards for collecting and organizing data to assess business trends, opportunities Summarizes complex situations or data sets into easily understood information Makes critical decisions using information gathered and develops others in their ability to organize their thoughts, identify patterns in data, and facilitate decisions making Leads broad problem solving efforts and guides others in identifying and analyzing problems and determining solutions Business Plan Development and Execution In collaboration with key internal and external partners can effectively (consistently and accurately) lead all components of a business plan (milestones, tactics, budgets, resources)Continually analyzes performance against plan and is proactive in planning sales activities to maximize customer calls and impactAble to write an integrated plan, which can be used during execution of multiple projects Manages multiple constituents at various levels of the organization to drive towards meeting timelines and milestones Evaluates the results of timelines and resource plans and recommends changes Evaluates regional performance vs. external benchmarks and works with Regional Directors to coordinate internal resources to improve performance benchmarks External Partnerships Coordinate with alliance partner sales management team within region geography Customer Management Manage key account coordination along with the District Managers to develop relationships leading to increased profitability and better patient outcomes Compliance Management Ensure full and complete compliance of all selling activities within the area of responsibility to OAPI standards and to all state and federal regulations Comply 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 Identify risks and issues associated with non-compliance and implications of regulatory infractions Qualifications
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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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This position is responsible for building and expanding upon the existing Vendor Management Program. This program currently covers key vendors in the Finance Operations Shared Services organization. Due to the growth of the program, Otsuka is looking to create a center of excellence for the governance of our vendors across the enterprise (OAPI, OPDC, ODH, OCPI). The vendor management group will work closely with Requestors of Services (ROS) who manage the vendor relationships. This position is a centralized governance role to help to stand up and administer the new vendor management program. Key activities include: - Managed the group performance and staff.- Creating a centralized governance model- Develop and mature the program by researching and bringing in best practices- Develop standards and templates to be used across Otsuka- Influence various business units to ensure consistency in the approach - Strategic oversight, guidance, sourcing, monitoring, governance and controls over external vendors and internal affiliate- Ensure vendor adherence to all heightened Operational, Information Security, IT, Compliance and Regulatory standards- Create and execute centralized reporting to monitor vendor performance against critical and contractual service level agreements. Development of performance scorecards covering all key client experience milestones - Staying abreast of current industry practices and bringing innovative ideas proactively into Otsuka
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- Proactive partner with the business on complex organizational challenges and manage people-related solutions- Understand every aspect of the business and contribute as a thought-leader regarding People and Organizational topics- Think big, use analytics to guide your work, be comfortable challenging convention, and in some cases, reinvent how work is done- Partner with a cross-functional group of subject-matter experts to design and execute strategy for how we staff, onboard, develop, motivate, retain and organize work- Partner with Business Leadership and HR team to ensure consistency of approach, message, and execution using proven tools in line with competency model- Support the implementation of major changes on people and the organization- Collaborate with HRBP team to ensure the cross-functional impacts are recognized and addressed- Reinforce a performance management strategy that provides clarity of direction, reliable measurement and clear feedback, drives accountability, focuses on coaching/development, and is underpinned by Otsuka core values and competencies- Contribute to the development of talent acquisition and pipeline strategies as well as employee development strategies – including temporary staffing to executive placement. - Work closely with management and employees to improve work relationships, build morale, increase productivity and retention- Partners with HR Operations (Total Rewards, HRIS, and Payroll) and Talent (Talent Management, Talent Acquisition, and Performance Management) to ensure life cycle transactions are managed in an organized and consistent manner using proven tools and assessments- Manage the delivery of cyclical programs to business clients ensuring consistency across HRBPs- Partner with client groups to support all yearend initiatives including compensation recommendations- Provide guidance and input on organization design, restructuring and resource optimization initiatives- Highly skilled in managing employee relations issues including participation in internal investigations and providing recommendations for resolution- Demonstrated ability to manage multi-business employee relations needs- Provides proactive and reactive advice and counsel to managers and supervisors regarding people practices, policy and employment laws. - Experience with University relations and internship programs. - Ensures compliance with all state and federal discrimination and employment regulations.
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This position will be responsible for interfacing with state and local mental health and renal disease patient advocacy groups, professional associations, government officials, and coalitions to align healthcare policy, advocacy and legislative priorities at the state level. The manager will develop strategies and coordinate initiatives with alliances that promote access to therapies, preserve patient/provider choice, and eliminate barriers to treatment. The position will be help shape and influence healthcare policies and provide feedback to OAPI regarding emerging regulatory/legislative issues that impact OAPI business. •Interact with state policy decision makers and influencers, advocacy leaders, governor's office policy staff, relevant state legislative committee chairs, members and support staff and Medicaid policy officials regarding issues impacting access to the continuum of care within the health care delivery system, in accordance with OAPI strategic objectives.•Develop working partnerships to support OAPI goals (i.e. consumer advocacy groups, professional associations, provider/medical organizations, government agencies, government officials, community leaders)•Identify key influencer stakeholders and work within a team environment to develop strategies to effectively support OAPI policy positions.•Conduct all activities in compliance with all applicable local, state and federal laws and regulations and company policies.•Position OAPI policy platform and corporate commitment; liaising between State Mental Health Authority, Medicaid Directors and Patient Advocacy organizations.•Monitor federal, state, and local payer systems and regulatory/legislative trends that potentially impact access to treatment and OAPI initiatives.•Gain insight regarding risks, issues, and opportunities through alliance development, translating into value added propositions.Represent OAPI in state PhRMA task force activities within assigned states.•Manage relationships and activities with local lobbying counsel in support of OAPI’s crisis issues and/or opportunities.•Communicate potential access risks to internal OAPI team with a sense of urgency, embracing a “no surprises” philosophy.Collaborate cross-functionally across OAPI departments to ensure favorable access/non-disadvantaged positioning.•Develop and implement state/regional advocacy plans on an annual basis.•Participate in Matrix Team meetings.•Execute appropriate marketing/policy initiatives with stakeholders through discussions, formal presentations, workshops, and programs as directed.•Implement patient and caregiver education and outreach programs via advocacy and professional organizations as directed.Represent OAPI at state/local conferences, symposia, and events, with the goal of becoming a recognized partner within the stakeholder community.
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Provides statistical input in the clinical development plan and protocols and conducts statistical analyses and summary of clinical studies and integrated database to help advance the drug development process. This is a strategic and critical role in effectively and efficiently developing the process for approval of drug products.Protocol development- Provides statistical analysis plan, including study design, sample size, primary and secondary endpoints, and statistical analysis method.- Reviews protocol outlines and protocols.- Produces randomization codes.- Reviews CRF.- Reviews and approves database structure and edit-check specifications.- Reviews and approves other clinical documents, such as clinical operation manual, investigator brochure (I), etc.- Develops final tables and listings (and figures) for clinical study report (CSR).- Develops Table of Contents (TOC) and Tables & Listings templates.- Develops a detailed Statistical Analysis Plan (SAP) to document technical considerations.- Provides specs to SAS programmers for generating analysis datasets.- Programs efficacy analysis and produces final efficacy tables and figures.- Reviews final tables, listings, and figures.- Develops tables and listings (and figures) for other regulatory submissions.- Performs statistical analyses for PK/PD parameters.- Provides safety tables and listings for IND annual reports and PSUR.- Provides tables and listings for FDA meeting briefing packages.- Performs exploratory analyses.- Performs statistical analyses for marketing and Phase IV studies.- Performs statistical analyses for abstracts, posters and publications.- Develops final study report (FSR).- Provides Statistical Methods section.- Summarizes Efficacy Results.- Reviews FSR.- Handles FDA or other regulatory agencies’ contracts and regulatory meetings.- Drafts response to questions from regulatory agencies.- Participates in preparing FDA briefing packages.- Attends meetings with Regulatory Agencies.- Interfaces with FDA statistical reviewers and serves on the rapid response team to address inquiries during the NDA review.- NDA submissions- Provides Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety ISS) tables.- Reviews ISS and ISE reports.- Prepares briefing packages for FDA Advisory Meetings.- Participates in responding to Advisory Committee questions in NDA defense.- Provides statistical inputs on Clinical Development Plan regarding primary efficacy end point, go/no-go decision criteria, size of studies, and statistical methodologies.- Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development.- Reviews clinical, statistical, and regulatory literature for current clinical trial results, regulatory trends and new statistical methods to be applied on his/her assigned therapeutic area.- Represents clients (internal OPDC, OPJ-C, and external partners) at FDA meetings, FDA advisory boards, or other scientific meetings.- Evaluates new statistical methodologies and software and their potential applications in our study design and analysis.- Takes full responsibility in managing biostatistical tasks (as listed below) for one therapeutic area and provides strategic technical support to other clinical projects.- Provides technical direction to supporting statisticians working on projects on a day-to-day basis.
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The 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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Provides statistical input in the clinical development plan and protocols and conducts statistical analyses and summary of clinical studies and integrated database to help advance the drug development process. This is a strategic and critical role in effectively and efficiently developing the process for approval of drug products.ResponsibilitiesProtocol development- Provides statistical analysis plan, including study design, sample size, primary and secondary endpoints, and statistical analysis method.- Reviews protocol outlines and protocols.- Produces randomization codes.- Reviews CRF.- Reviews and approves database structure and edit-check specifications.- Reviews and approves other clinical documents, such as clinical operation manual, investigator brochure (I), etc.- Develops final tables and listings (and figures) for clinical study report (CSR).- Develops Table of Contents (TOC) and Tables & Listings templates.- Develops a detailed Statistical Analysis Plan (SAP) to document technical considerations.- Provides specs to SAS programmers for generating analysis datasets.- Programs efficacy analysis and produces final efficacy tables and figures.- Reviews final tables, listings, and figures.- Develops tables and listings (and figures) for other regulatory submissions.- Performs statistical analyses for PK/PD parameters.- Provides safety tables and listings for IND annual reports and PSUR.- Provides tables and listings for FDA meeting briefing packages.- Performs exploratory analyses.- Performs statistical analyses for marketing and Phase IV studies.- Performs statistical analyses for abstracts, posters and publications.- Develops final study report (FSR).- Provides Statistical Methods section.- Summarizes Efficacy Results.- Reviews FSR.- Handles FDA or other regulatory agencies’ contracts and regulatory meetings.- Drafts response to questions from regulatory agencies.- Participates in preparing FDA briefing packages.- Attends meetings with Regulatory Agencies.- Interfaces with FDA statistical reviewers and serves on the rapid response team to address inquiries during the NDA review.- NDA, sNDA, MAA, NDS, sNDS, PMDA global regulatory fillings- Provides Integrated Summary of Efficacy (ISE/SCE) and Integrated Summary of Safety (ISS/SCS) tables.- Reviews ISS/SCS and ISE/SCE reports.- Prepares briefing packages for FDA Advisory Meetings.- Participates in responding to Advisory Committee questions in NDA defense.- Provides statistical inputs on Clinical Development Plan regarding primary efficacy end point, go/no-go decision criteria, size of studies, and statistical methodologies.- Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development.- Reviews clinical, statistical, and regulatory literature for current clinical trial results, regulatory trends and new statistical methods to be applied on his/her assigned therapeutic area.- Represents clients (internal OPDC, OPJ-C, and external partners) at FDA meetings, FDA advisory boards, or other scientific meetings.- Evaluates new statistical methodologies and software and their potential applications in our study design and analysis.- Takes full responsibility in managing biostatistical tasks (as listed below) for one therapeutic area and provides strategic technical support to other clinical projects.- Provides technical direction to supporting statisticians working on projects on a day-to-day basis.
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TheSenior Scientist Clinical Pharmacology will help develop and implement clinical pharmacology programs that support product development, registration, differentiation and personalization. The Senior Scientist will interact with team members to identify and define mechanisms of action, biomarkers and new drug targets. The Senior Scientist is expected to help design clinical pharmacology trials and select pharmacokinetic (PK)/pharmacodynamic (PD) /biomarker assessments in all phases of development, work on development of physiologically-based pharmacokinetic (PB-PK) models extrapolating animal to human and within human for prediction of changes in PK with new formulations, disease state, pediatric, etc., conduct PK/PD analysis and reporting, contribute relevant sections to regulatory filings, work with pharmacometricians to develop PK/PD models and contribute to commercial strategies.- Help develop and execute Clinical Pharmacology strategy for given programs- Collaborate with clinical development to design and implement innovative early clinical development strategies from first-in-man through pharmacological/biomarker proof of concept (Phase Ib/Phase 2a)- Identify new drug targets and biomarkers through analysis of drug mechanism of action and patient characteristics (e.g., phenotype, genotype, etc.)- Provide input to project teams on biopharmaceutics, pharmacogenomics and biomarkers.- Work on development of physiologically-based pharmacokinetic models extrapolating animal to human and within human for prediction of changes in PK with new formulations, disease state, pediatric, etc.- Help design clinical pharmacology trials and is responsible for the generation of protocol outlines- Coordinates with bioanalytical scientists on types of analytes, limits of quantitation, and response range required of the bioanalytical methods used to support clinical trials.- Analyzes PK and PD data using non-compartmental and compartmental methods and prepares PK and PD sections of study reports and regulatory submissions documents.- Works with pharmacometricians to develop PK/PD/efficacy models.- Prepares and may present PK/PD information to internal clinical development and commercialization teams, regulatory agencies, and scientific boards and at investigator meetings.- Provides input to Department Head on departmental practices, templates and workflows.- Minimum of 5% travel based on business needs
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Maintain a project-level perspective on data management issues, activities and deliverables. Oversee the ContractResearch Organization (CRO) and third-party vendor processes involved in developing data collection systems, data cleaning and providing data deliverables conforming to global Otsuka CDISC standards. Provide strategic input into protocol design from a data management perspective. Represent the Data Management Department on project teams and manages flow of data from collection to submission. Work with representatives from all functional areas to develop and maintain consistency, accuracy and quality of data across therapeutic areas. - Works collaboratively with CROs and third-party vendors to design database, define quality specs, and resolve data management-related issues.- Assists in developing and maintaining DM standards and processes for both in-house and CRO studies in accordance with applicable standard operating procedures (SOPs) and GCPs.- Provides consultation, leadership, and expertise to CRO DM and project teams on Data Management functions.- Acts as the Data Management lead for all assigned protocols, including contributing to the development and implementation of project plan.- Ensure standard processes are followed by all CROs for data management activities. Train CRO personnel on current processes.- Uses software applications to monitor and evaluate CRO performance (e.g. query status, data trends, detecting outliers and study progress).- Acts as a resource to the contract staff to identify problems and propose solutions to maintain projects within designated timelines.- Proactively identifies and implements opportunities for process improvements.- Provides expert review and help in the development of CRF/eCRF/eSource design specifications, validation specifications and report design, etc. Works with external service providers to help troubleshoot and resolve problems. - Ensures the consistency of CRF design and coding across studies and programs. - Contributes to protocols, clinical study reports, Investigator Brochures, Statistical Analysis Plans, INDs and other regulatory documents.- Prepares submission ready Electronic Case Report Forms (eCRFs) to support electronic submissions.- Reviews SOW, provides input and ensures consistency across programs for Data Management activities to be outsourced to CROs.- Manages third party vendors’ (e.g., CROs, EDC/eSource, and ancillary) processes, and local/central laboratories on defined data standards, content specifications, and timelines for deliverables.- Communicates and interacts with CRO vendors to ensure that project timelines are met with quality.- Provides status reports on the progress of projects/programs to internal team.- Ensures data management related presentations for Investigator’s meetings adhere to Otsuka requirements.- Provides input in the development of departmental and global SOPs.- Serves as project team member and works closely with biostatistician and programmer to provide quality deliverables.- Other tasks assigned by Associate Director, Director or Sr. Director of Data ManagementTravel (approximately 10-20%)
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This role is responsible for management of the day-to-day activities within the General Accounting and Financial Reporting Functions, including the preparation, analysis and review of general ledger activity, financial statements and associated monthly, quarterly and annual reporting requirements. It requires knowledge of Finance and Accounting principles, proficiency with Microsoft Excel, and ability to understand and utilize financial systems. Primary responsibilities include: - Managing the day-to-day operations of the accounting department, including journal entry reviews and approvals and timely completion of tasks in accordance with close deadlines.- Supervising accounting department personnel, including providing work direction and guidance, monitoring and balancing workloads to ensure timely and accurate work production, reviewing assignments and providing leadership, coaching and feedback.- Managing the preparation and review of the monthly financial statements and reporting packages, ensuring conformity with IFRS.- Identifying and implementing process improvements.- Ensuring timely reconciliation of balance sheet accounts and routine P&L analysis.- Performing accounting research and documenting the company’s accounting treatment and position on unique and complex matters.- Assisting with implementing, socializing and operationalizing accounting policies, procedures and new accounting pronouncements.- Supporting all internal and external audit requirements.The professional development benefits of this role include the opportunity to influence colleagues, business partners and key stakeholders on accounting and reporting best practices and the opportunity to effect positive change and drive value through process simplification and improvement, with continuous exposure to senior management. In this role you will:- Assist in planning, organizing and coordinating the close process;- Establish policies and procedures in compliance with IFRS standards;- Establish robust documentation of the company’s accounting positions;- Enhance reporting and analytics through process improvements and business partnering;- Support both internal and external auditors;- Work closely with internal controls to ensure J-SOX compliance;- Interact with Senior Leadership to provide accurate financial information;- Provide mentoring and coaching to the accounting team and others as needed.
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The Manager, Commercial IT engages and partners with cross functional business teams to gather business requirements, perform gap analysis, develop functional requirements, define solution recommendations, partner with internal and external development teams to execute the projects, lead UAT and provide operational support to current production systems.The Business Analyst will primarily drive Veeva CRM changes and should be familiar with pharma sales operations processes. The candidate should be an expert in Veeva CRM/Salesforce.com functionality and will collaborate closely with Commercial Operations, Sales, IT Operations and Marketing. The position will report to the Associate Director, Commercial IT.Core Responsibilities- Act as the primary operational IT contact for Veeva-related business processes - Understand business processes and problems and create solutions to meet desired business outcomes.- Lead requirements gathering efforts (Business Process/Functional and Technical Specifications) for the CRM application suite across Sales teams.- Establish agile release definitions in partnership with business owner for concurrent initiatives. This includes identifying scope, deliverables, timelines, and leading status meetings.- Translate and document non-technical requirements into technical requirements and design.- Educate development teams on the proposed solution to ensure effective development cycles.- Test developed solutions as needed and facilitate UAT with business partners.- Continually assess business needs and implement measures that will ensure customer expectations are met or exceeded by enhancing system capability and performance.- Document and track change requests and facilitate prioritization discussions with IT and business owners.- Generate meeting minutes, documentation, presentations and reports as needed.- Create training materials for solutions and deliver training to end-users.- Coordinate activities with offshore vendor resources.
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The Senior Manager - R&D IT Product Management at Otsuka will engage with different roles and function to provide architectural overview of proposed solutions outlining components, relationships and dependencies that will serve as the primary basis of timely decision making. Collaborate and partner across lines of business and the IT groups in order to understand strategic drivers and tactical needs to ensure implementation teams can provide technically innovative solutions that meet the business needs with the necessary usability, technical stability and scalability. Other responsibilities include: - Plan and develop the Architectural Runway in support of new business Features and Capabilities.- Produce information flows, architecture, technology roadmaps and technical implementation blueprints in close alignment with business capability roadmaps.- Ensure solutions being developed, takes global needs into accounts, architecturally flexible to extend to related business areas and affiliates ensuring maintainability and supportability of systems and are enterprise grade. Support projects and operational activities in the Global Quality solutions portfolio.- Develops, assigns and implements systems, procedures and policies to assure compliance with cGMP's and FDA regulations and company policies and procedures. Assess all plant systems, operations, products, processes, procedures, and documentation for adequacy and effectiveness to ensure Quality and Regulatory Compliance related to CAPA.- Experience in establishing QMS life cycle process models aligning with GxP/21 CFR Part 11/ GAMP 5 requirements.- Ensuring GxP computerized systems operate within the framework of regulations or standards (GxP, 21 CFR Part 11 and GAMP 5) applicable company Quality Modules and requirements defined in Global and local procedures.- Have complete domain knowledge of Pharmaceutical, Biotechnology and Life Sciences.- Experience in providing trainings on Domain Knowledge, GxP Compliance, Testing & Deviation Management, Validation Process and Methodologies.- Actively seeks and drives opportunities for continuous improvement of applications, during team’s project work and for internal processes.- Create and own the Solution Architecture documentation and works closely with the technical team (Technical Project Manager, Lead Developer, developers/software engineers, testers) to monitor technical development of solutions; configures the system when necessary.- Actively participates in Architecture Community of Practice internally and/or externally (industry forums, vendors etc.)- Ensure that Solutions are technically/ architecturally consistent, fit for purpose, meet customer requirements and comply with all relevant IT and business standards such as reuse of technologies and solutions, and simplicity and usability.- Actively seeks and drives opportunities for continuous improvement of applications, during team’s project work and for internal processes.- Ensure support of key business processes and appropriate levels of integration / automation.- Help bridge the gaps and hand-offs issues between requirements / functional resources, development teams, and project leadership / sponsorship.- Provide leadership to ensure that capabilities delivered align with original business objectives, application service levels, IT strategies, and design intent.- Synthesize and communicate complex technical and business information easily to senior management and business stakeholders.- Develop strategy and execution plans for implementation of cutting-edge technologies and processes while managing the ongoing needs of application development and support. Work within IT and with other cross-functional groups and with vendors, to successfully identify, prioritize, and resolve issues and work on enhancements, developments, and operational improvements.- Create and manage project plans and timelines, define project deliverables, assign project team roles and resources, identify and track issues and their resolution, and manage project scope and requirements.- Lead requirements workshops, design, prototype, configure and document content management/QMS data solutions.
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The SR Manager Device Development & Technology is an Individual Contributer role, reporting to the Director/Associate Director of Device Development and Technology. This individual will be responsible for Program Management of Device Development. They will also be the technical expert in the field of combination products & drug delivery devices who can effectively navigate and balance complex engineering, regulatory, quality and commercial needs while developing the best product for the user and patient. Primary expertise should be demonstrated in engineering, device regulatory, device quality systems (CFR 820, ISO 13485), human factors engineering principals, risk management for medical devices (ISO 14971), etc. The successful candidate should demonstrate strong technical writing and presentation skills and be able to translate technical information to non-technical audiences. This position requires 7 - 10 years of applicable experience in the pharmaceutical, biotechnology or medical device industries. The candidate will be responsible for the creation and management of design history files and technical dossiers for combination and device projects for new and existing products. Additional responsibilities include facilitation of risk assessments, coordination of human factors usability studies, creation and management of product and component specifications, design control documents, engineering protocols and reports and frequent presentations to project teams and management. This position will frequently require management of outside resources as well as assigned and/or unassigned leadership of project teams in a matrix organization. Technical Writing experience required. The position may involve frequent domestic and international travel up to 10% or as required by the project. Will manage indirect reports. Support the vision for the Device Development function- Support and implement a vision with appropriate strategies that supports the OPDC objectives and aligns with the business and OPCJ/OPDC/MDD development programs- Work with members of Device Development and Technology, and other functions including Packaging, Supply Chain, Clinical Supplies Operations, Quality Control, Regulatory and Quality Management to support strategies for product and process improvements - Support the development of flexible and compliant product development process.Develop and support the strategic activities of the department:- Support and implement appropriate filing strategies working with OPCJ, OPDC, MDD and OAPI departments to support registration of all new products and life-cycle management products.- Initiate and manage the development and implementation of policies, procedures, and standards for the Device Technology department. - Evaluate and recommend strategic directions for new and innovative delivery device technologies to support new and life-cycle management projects.Develop and perform the tactical activities:- Ensure efficient transfer of products and on-going product support all products to CMO’s from device perspective.- Develop and maintain departmental knowledge, experience, and expertise in state-of-the-art devices for pharmaceutical products.- Assure adherence to latest worldwide regulatory rules and guidance concerning devices and work to develop device risk mitigation.- Create, maintain and update device related documents required for regulatory filings and compliance - Facilitate studies as required.Program management of Device projects:- Develop project plans and corresponding project managements tools to support the execution of all projects- Manage cross functional teams (including 3rd party resources)- Execute Human Factors Engineering & Usability activities- Write protocols, reports, specifications, procedures, change control requests, technical assessments, etc
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The Account Manager is considered to be skilled or advanced in their demonstration of account management capabilities and sales proficiencies. This individual contributor is self-sufficient and able to apply skills successfully in all situations. Specifically the Account Manager will demonstrate ability in the following areas: Local Market Expertise - Ability to collaborate with internal and external partners to gather and validate key trends and dynamics in the market, map account linkages including stakeholders that exhibit direct and indirect influence on customer behavior. Utilize market knowledge to uncover and prioritize unique opportunities that will allow for mutual value between Otsuka and our customers Reimbursement - Consistently demonstrates the ability to stay informed on reimbursement dynamics, anticipate and communicate impact on product portfolio to key internal and external partners and problem solve payer access issues (Medicare, Medicaid, Commercial) through the use of Otsuka resources Business Planning and Execution - Ability to prioritize opportunities, develop strategy & tactics,, allocate resources, monitor progress and adjust direction in an effort to maximize sales performance and measure progress against plan Critical Thinking - Ability to understand a situation, issue, or problem by breaking it into smaller components. Ability to collect information, derive inferences, find solutions and make informed decisions and recommendations using data and tools where appropriate Pharmaceutical Environment - Ability to apply knowledge of pharmaceutical and regulatory environment, including Otsuka policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply knowledge of overall healthcare economy and industry practices Therapeutic Area Knowledge - Ability to apply therapeutic area knowledge to the sale of Otsuka’s products and/or to increase effectiveness in role Customer Development - Build and maintain productive internal and external relationships (e.g. customers, account contacts, stakeholders and influencers e, etc) based on customer needs and organizational goals Selling - Understand the core selling process, adapt style, and effectively negotiate to bring value to the customer and close the sale Key Job Responsibilities: Drive for Results -Can be counted on to exceed goals successfully, is constantly and consistently able to develop top performing teams, very bottom-line oriented, steadfastly pushes self and others for results. Peer Relationships - Can quickly find common ground and solve problems for the good of all, can represent his/her own interests and yet be fair to others, can solve problems with peers, direct reports and matrix team members with a minimum of noise, is seen as a team player and is cooperative, easily gains trust and support of colleagues, encourages collaboration. Critical Thinking Establish standards for collecting and organizing data to assess business trends, opportunities Summarizes complex situations or data sets into easily understood information Makes critical decisions using information gathered and develops others in their ability to organize their thoughts, identify patterns in data, and facilitate decisions making Leads broad problem solving efforts and guides others in identifying and analyzing problems and determining solutions Business Plan Development and Execution In collaboration with key internal and external partners can effectively (consistently and accurately) lead all components of a business plan (milestones, tactics, budgets, resources)Continually analyzes performance against plan and is proactive in planning sales activities to maximize customer calls and impactAble to write an integrated plan, which can be used during execution of multiple projects Manages multiple constituents at various levels of the organization to drive towards meeting timelines and milestones Evaluates the results of timelines and resource plans and recommends changes Evaluates regional performance vs. external benchmarks and works with Regional Directors to coordinate internal resources to improve performance benchmarks External Partnerships Coordinate with alliance partner sales management team within region geography Customer Management Manage key account coordination along with the District Managers to develop relationships leading to increased profitability and better patient outcomes Compliance Management Ensure full and complete compliance of all selling activities within the area of responsibility to OAPI standards and to all state and federal regulations Comply 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 Identify risks and issues associated with non-compliance and implications of regulatory infractions Qualifications
