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Job Locations US-NJ-Princeton
 The Sr. Associate Regulatory Affairs will support the regulatory affairs team for both product and non-project initiatives.  The candidate will support the Regulatory Affairs staff, ensuring that agreed upon work is executed and objectives are met within timelines and requirements.In order to work effectively, the successful Sr. Associate Regulatory Affairs candidate should have a general understanding of the pharmaceutical/biotechnology industry. Experience with regulatory, quality, clinical, non-clinical, process & development or manufacturing is desired.  Job Responsibilities: • Program management and meeting coordination for:o Senior Global Regulatory Affairs Teamo Lead Innovation efforts and other initiatives o Global and Local regulatory activities o Submissions Project Management Officeo Preparation of regulatory portfolio and management presentations o RegOps stakeholders meeting management (logistics and notes), o Operations Forum monthly presentation o SOP support for Doc Mgmt/Inspection readiness RA group -  Operational and document management of SOPs, o Develop and maintain key quality and performance indicatorso Support for other activities for Doc Mgmt/Inspection readiness RA groupo Budget and resource management preparation o Creating and managing complex, integrated projects plans and Ganttso Coordinating meetings, developing agendas, writing and issuing minutes and tracking action itemso Preparing and managing program documents and program status reports.o Developing and managing program MS SharePoint contento Provide creative and innovative ideas to move the Regulatory department forward to address current and future challenges
ID
2017-9690
Category
Global Regulatory Affairs
Job Locations US-Remote
This position will be responsible for representing OAPI with key VA and DoD institutions and national offices and all Non Retail Accounts.   This includes interacting with all required national personnel to attain and maintain optimal access for OAPI market brands. The position will report to the Regional Business Director of OAPI Market Access - West. - Represent OAPI within the VA and DoD and all Non-Retail Accounts- Serve as the key negotiator with assigned accounts- Work collaboratively with VA and DoD and other Non Retail contracting groups for submission of bids and management of contracts- Assist in assessing customer behavioral trends, market conditions, and changes in formulary/medical policy techniques- Execute the development of Account Plans- Ensure compliance with all VA, Non Retail, and OAPI policies and procedures- Execute all regional specific Annual Business Plans- Collaborate with Sales Regional Business Director/ District Business Manager peers and Sr. Account Executive peers to optimize business performance and/or manage complex business risks and issues.- Contribute to development of product and channel specific contract strategies in collaboration with Otsuka Pricing Committee- Execute Account Management CRM tool and processConduct all activities in compliance with all applicable local, state and federal laws and regulations and company policies. 
ID
2013-5196
Category
Market Access
Job Locations US-NJ-Princeton
 The Corporate Attorney provides Legal support for clinical development and commercial activities of the company. - Provides legal review of contracts, protocols, informed consents, and scientific communications. - Drafts, reviews and manages a variety of contracts and agreements.- Provides legal review of promotional materials and activities, grants and medical education activities.- Provides support for patent, licensing, trademark and copyright matters.- Offers guidance to project team activities to ensure compliance with company policies and legal/regulatory requirements.- Provides legal guidance for compliance activities.- Other duties and responsibilities as assigned. 
ID
2018-10160
Category
Legal
Job Locations US-MD-Rockville
 The Corporate Attorney provides Legal support for clinical development and commercial activities of the company.- Provides legal review of contracts, protocols, informed consents, and scientific communications. - Drafts, reviews and manages a variety of contracts and agreements.- Provides legal review of promotional materials and activities, grants and medical education activities.- Provides support for patent, licensing, trademark and copyright matters.- Offers guidance to project team activities to ensure compliance with company policies and legal/regulatory requirements.- Provides legal guidance for compliance activities.- Other duties and responsibilities as assigned. 
ID
2018-10159
Category
Legal
Job Locations US-MD-Rockville
The Corporate Attorney provides Legal support for clinical development and commercial activities of the company.-  Provides legal review of contracts, protocols, informed consents, and scientific communications. - Drafts, reviews and manages a variety of contracts and agreements.- Provides legal review of promotional materials and activities, grants and medical education activities.- Provides support for patent, licensing, trademark and copyright matters.- Offers guidance to project team activities to ensure compliance with company policies and legal/regulatory requirements.- Provides legal guidance for compliance activities.- Other duties and responsibilities as assigned.
ID
2018-10158
Category
Legal
Job Locations US-NJ-Princeton
This individual will report into the market access function, but work cross-functionally with sales, brand, trade, business analytics and commercial partners to drive strategic decisions and tactical programs that provide customer value for payers across therapeutic categories and over the lifecycle of products. The development of promotional and educational materials to support the field account executives, and other field personnel is a key deliverable for this function. This position will be responsible for building channel and brand payer strategies, collaborate on creating the value proposition and evidence generation strategy for US payers, segmenting payers, creating personal and non-personal tactics, managing the related budgets. Additionally, providing insight into pricing strategic plans will be a component of this position. The Assoc Director may also lead strategic market monitoring and 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 Assoc Director in this role must have hands-on payer marketing experience developing winning strategies that drive value and access in complex payer markets. This includes an in-depth-knowledge of payer customer environment, buy-and-bill systems, and an understanding of the evolving reimbursement landscape. They must have worked in a payer marketing role or had relevant experiences that demonstrate strategic thinking, driving results and customer orientation.7-10 years in the pharmaceutical industry with the majority of time in managed markets and marketing. • Understand and educate the organization on market access landscape, channels, and strategieso Develop Channel and Brand specific  marketing strategies and associated tactics to support corporate and brand objectives and execution requirements thru all resourced Market Access Field teams.o Develop pull through strategies aligned to market access and brand objectiveso Direct Brand specific Market Access Market research activities.o Lead Market expansion opportunity projects• Lead cross functional market access strategy team to deliver an integrated market access strategy for the corporation while aligning to  customer value with each engagemento Develop and maintain value message platform for Brand.o Direct and create the necessary promotional tools that support Account Executive efforts with key customers and pull through of payer opportunities in the field with customerso Manages key Agencies of Record to deliver tools and tactics• Lead budget planning process for Market Access and Manage Market Access Marketing Brand budget resources.• Engages and informs commercial partners.
ID
2018-10128
Category
Managed Markets
Job Locations US-NJ-Princeton
This position is a shared service for the commercial, development and OPCJ (Japan) areas of the pharmaceutical business referred to as OAPI, OPDC, and OPCJ respectively. Responsible for analytics for OAPI and as needed for OPDC and OPCJ as part of the Business Development Analysis. This role reports to the Director of Business Development and Analytics as part of the functional team. The Manager/Sr. Manager in this role will be expected to provide critical support to the Director in elevating capabilities of this team and place it among the leaders in business development and analytics. The main client in this role is the OAPI and OPCJ Business.The position requires oversight regarding the market assessment of various assets and pipeline portfolios to support business development opportunities, as well as portfolio management across a number of brands, forecast and valuation of business opportunities in US and other international markets. The position requires strengths in business analytics as well as broad understanding of pharmaceutical markets. The person in this position will be part of the OAPI core team and will be interacting directly with OAPI and OPCJ.This position requires a person who can work independently, work on own projects, direct vendors and create robust methodological approaches to business opportunity valuations. The successful leader must feel comfortable working across a complex matrix environment including interaction with third party vendors, various departments in OPDC and OPCJ, senior management and current and potential partner companies. Support & Advise OAPI Director– commercial strategy on business development analytics and forecast of business development opportunities- Support OAPI business teams on their business analytical needs in business development and potentially LCM activities • Organize projects and deliverables for the team as well as that of third party vendors • Leads the design, plan, execution and delivery of primary and secondary market research projects across different therapeutic areas in support of business development • Leads and/or directly performs ad-hoc business analysis across multiple therapeutic areas including but not limited to CNS, Oncology, Renal and Cardiovascular. Types of analysis may include situation analysis, sales forecasting, product assessment, and LCM assessments • Responsible for managing the budget of Business Development analytics.- Lead special projects as required by the needs of the business (e.g. business development initiatives) • Represent the function in different business meetings both domestically and globally • Work with other Otsuka analytics function in interactions with current and potential partners in different capacitiesOversee and deliver Quantitative analysis in BD • Comprehensive knowledge of and experience with pharmaceutical data sources is a must. This includes but not limited to strong knowledge and experience working with Secondary Market Research Data such as national Sales (IMS, Symphony), patient databases (Truven, Pharmetrics etc.), physician level sales and prescribing data (Xponent, Plantrak, etc), account level sales data, audit data sources (IMS MIDAS Audits, etc.), Redbook, syndicated data sources (DRG, Globaldata, Datamonitor, etc.)
ID
2018-10149
Category
Customer Insights & Business Analytics
Job Locations US-NJ-Princeton
With limited supervision, prepares, reviews, and updates content that is required for the development and maintenance of labeling and labeling components. Ensures that all labeling and components meet regulatory and company requirements. The ideal candidate will be results-oriented with concerns for quality and collaboration. They will show initiative and want to continue to develop and acquire new expertise. May be assigned additional responsibilities as deemed necessary. Responsibilities- Provides operational support including but not limited to quality checks, document submissions and inspection readiness.- Tracks global labeling implementation and provides operational support to fulfill and meet local heath authority requests and deadlines. - Analyses and interprets new regulations and guidances as well as monitors and determines the impact of the regulatory environment and applicable regulatory decisions affecting labeling.- Drafts labeling materials to ensure that the information conveyed is consistent with the applicable data for the product. - Provides input into the product development and regulatory strategies and translate into appropriate labeling language throughout the lifecycle of the product. - Follows and recommends improvements to labeling policies, processes, quality, and system tools.- Provides training to employees on regulations for labeling compliance and system tools.- Provides creative and innovative ideas to move the Global Labeling and Regulatory department to address current and future challenges. - Reports into Director, Global Labeling and preferably based in the Princeton, New Jersey office.
ID
2018-10147
Category
Global Regulatory Affairs
Job Locations US-NJ-Princeton
The Manager, Sales Operations Support position requires a commercial operations professional who possesses strong customer service focus, has a solid understanding of pharmaceutical field force help desk support processes and practices, pharmaceutical sales operations functions and processes, field force communications and training, as well as a working knowledge of commercial applications, systems and underlying data.As a member of the Sales Operations team, the Manager, Sales Operations Support represents the needs and interest of Otsuka’s therapeutic area field forces and serves as escalation point for help desk tickets, field inquiries, solution service request, remedial training requests and other issues/requests that require Home Office intervention or approval for their resolution.The Manager, Sales Operations Support assist the sales automation solutions business owners with the management, administration and training of the organizations Customer Relationship Management (CRM) solutions and other commercial applications, for the implementation of new automation capabilities, systematic enhancement of underlying business processes and the maintenance of the integrity and quality of enterprise data.The Manger, Sales Operations Support position requires the ability to interact with a variety of internal Sales Operations, Information Technology, Business Services and other home office departments, co-promotion partners and outside vendors across the matrix. Responsibilities also include the evaluation of new CRM tools with potential commercial applications, vendor management support and project/program management support.• Leads CRM Support Tier-2/Tier-3 triage activities and acts as a centralized coordination point to review and resolve field inquiries and other issues/questions escalated from the Tier-1/Tier-2 Help Desk through partnering with various internal & external stakeholders including Information Technology, Sales Operations, Data Management, Segmentation & Targeting, Legal & Compliance, Third Party Vendors and Business Partners. • Works with Business Service group on overseeing Tier-1/Tier-1.5 Help Desk vendor activities, and ensure user issues and questions are addressed in a timely manner with high quality. This includes training of help desk specialists and providing them assistance so that they can perform their job effectively, defining SOP’s and SLA’s, evaluating of help desk metrics, and proactively soliciting user feedback, etc. • Supports CRM solutions training lead, assists with the coordination of training department and training vendor activities, creates SFA training content and modules, prepares training data for CRM training courses, and conducts field force training for new systems, new hires and ongoing remedial training. Coordinates train-the-trainer sessions and maintains documentation of system updates and user manuals. Authors’ communications for enhancements, changes, best practices and FAQ’s.• Represents the needs and interest of Otsuka field forces and conducts frequent meetings with field force stakeholders, sales operations colleagues and Learning & Development to collect feedback on CRM processes and toolkit effectiveness, track toolkit utilization and provide field support level metrics.• Supports the administration and maintenance of Customer Relationship Management (CRM) solutions and partners with IT on the analysis, design and implementation of new CRM applications, enhancements, feature releases and special projects, including defining roadmaps and project plans, project status reports, issue logs, testing plans, training & transition plans, etc.• Assists with the Development and maintenance of rigorous quality control process and measures that ensure the accuracy of all information disseminated though CRM applications to the field force. Assists maintaining the integrity of enterprise data systems and supports enterprise information governance efforts.• Supports system integration testing (SIT) and coordinates user acceptance testing (UAT) for CRM projects including authoring testing plans and test scripts, tracking testing results, defining tollgates and testing closure.• Support PM/PMO efforts, manages tasks, dependencies, issues & risks across Sales Operations initiatives and formal projects, including the coordination with other commercial organizations, OIT, vendors, Co-promoters and other business partners to ensure completion on time and within budget. Assist with the long-range planning and implementation of customer relationship management (CRM) technology solution for the field force.• Supports business process management and optimization efforts and defines metrics and monitor Sales Operations department performance against productivity targets (e.g. quality of work products, cycle times, project & program execution, etc.). 
ID
2018-10114
Category
Sales Operations
Job Locations US-NJ-Princeton
Responsible for the design and oversight of clinical research programs and protocols for OPDC products. The incumbent will also be responsible for the clinical development of CNS compounds at different stages of development. Additional Responsibilities: - Develops relationships with key opinion leaders and applies their input to enhance study design and protocols.- Serves as a medical/scientific consultant to marketing, research project teams, and regulatory agencies.- Establishes the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of drug or medical device product candidates. Interprets 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.- Oversees the CRO relationship, and provides input into the governance committee.- Will help lead and support regulatory filing activities and documentsProvides input into ESP field monitor selection, as assigned. Reviews and approves CVs for ESP monitoring staff.Performs other duties as assigned.
ID
2018-10140
Category
Global Clinical Development
Job Locations US-MD-Rockville
The Project Manager/ Coordinator, Publications and Operations under the direction of the Director, Scientific Communications and the Assoc. Director Medical Affairs will facilitate a compliant publication process and assist with operational initiatives for medical affairs. Primary responsibilities will include but are not limited to assisting in scientific communications materials development, editorial review of documents, document tracking in Datavision (e.g., reporting and monitoring processes) and operational activities including, but not limited to, budget/forecast management, research management, and process improvement across the department. These activities will support the US and Global Brand initiatives and research goals across therapeutic areas including products in development, health outcomes and special project areas as needed to meet the business objectives.   Publication Support:- Drives the execution of compliant publication plans and supports publication team needs - Oversees agency deliverables and assists with editorial development of manuscripts, abstracts, posters, slides, and completes publication checklists for all material to assure compliance with all publication guidelines, Otsuka policies and SOPs- Maintains accurate and timely entries in the publication management system at all times and coordinates all necessary review and approval activities- Interacts with alliance partners and affiliated companies to ensure that compliant publication processes are followed, facilitates a transparent publication process, participates in publication discussions at team meetings, ensures compliant publication plans are developed and followed- Medical Affairs finance management, research management, and cross-functional support.
ID
2018-10134
Category
Medical Affairs
Job Locations US-NJ-Princeton
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. Invite your network of journalists, key influencers, and social and digital connections to collaborate with us as thought leaders. 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 strong ability to work independently in a fast-paced, big venture 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, strengthen media coverage and think strategically. Our Corporate Marketing lead will manage the PR, Digital and Social Media teams and work collaboratively with executives, business stakeholders, alliances, the media and key influencers to increase Otsuka brand awareness, differentiate our company and products in the industry, position our executives as thought leaders and protect our corporate image and reputation via traditional and online media and campaigns. Established relationships with media professionals and industry conference producers is preferred. Proven experience with national brand campaigns and social media activation also a plus.  Key Job Responsibilities:- Lead corporate-level brand platform and strategic marketing efforts. Build, manage and execute effective and strategic marketing plans in a fast-paced environment. Develop long-term growth strategies and national corporate brand campaigns with internal and external stakeholders and agencies. Bring the Otsuka story to life. - Develop and maintain strong and strategic executive and client relationships. Advise clients on campaign strategies and message development. Generate effective communications and alignment in a heavy consensus style environment. 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. Plan industry conferences, events and online experiences to help convey the narrative.- 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 Public Relations, Digital and Social Media teams and serve as a coach to assist in career development and growth. Supervise Public Relations, Digital and social media activities and execute across multiple commercial brands and R&D business through product life-cycles and/or corporate narrative. 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.
ID
2018-10136
Category
Corporate Communications
Job Locations US-NJ-Princeton
Post-doctoral scientist/Research Fellow will support translational research and/or technology development for drug discovery and clinical development, clinical trial operational efficiencies, digital assessments and health products, and other intelligent scientific/innovation information management tools. This is a short-term position for approximately 1 year and can be extended for an additional term upon satisfactory progress.Additional Responsibilities:- Support translational research in the CNS and oncology disease areas on the identification of prognostic and predictive digital/molecular/imaging biomarkers, characterization of disease and its progression, and identifying/development of new assays towards diagnostics/algorithms that enable personalized/precision medicine by guiding targeted, individualized use of therapies to the patients that will benefit the most.- Develop innovative AI/machine learning/NLP/Signal Processing/Logic/statistics and mathematical modeling methods to provide therapeutic insights by leveraging internal, external and real world data sources. Experienced in graphical modeling (Bayesian networks, Hidden Markov modeling) and/or deep learning.- Guide evidence based product development by extracting market intelligence from such real-world data sources through knowledge representation and pattern recognition.
ID
2018-10125
Category
Data Sciences
Job Locations US-NJ-Princeton
Responsibilities: The Director of Forecasting within the Business Analytics & Insights organization at Otsuka is responsible for leading the forecasting team to develop and manage rigorous commercial forecasts for all Otsuka assets.  Scope of responsibility includes forecasts for business development assets, early development assets, pre-launch assets, inline assets and life-cycle opportunities.  Moreover, forecasting oversight spans across all disease areas of company interest, including Central Nervous System (CNS) disorders, Renal disease, Oncology, and Digital Medicine. The Forecasting lead reports directly to the Senior Director of Business Analytics & Insights as part of the Commercial Operations organization. Key stakeholders that the Forecasting lead will work with include brand leads and cross-functional partners, as well as senior management.Knowledge and Skills Requirements:• Proactive leader that will take ownership of all forecasting initiatives and processes• Visionary that can drive development of a Forecasting Center of Excellence that can be a recognized leader in the industry• Excellent management skills that can be used to guide and coach a talented team of forecasting experts• Ability to hire, manage and develop forecasting personnel to ensure teamwork, camaraderie and exceptional performance• Strong strategic thinking skills and demonstrated ability to connect information and insights across multiple data sources.• Solid business knowledge to effectively pressure test and shape forecast assumptions• Knowledge of multiple data sources that can be used to inform forecast assumptions, including prescription data, claims data, patient level data, demand studies and other primary market research• Broad and deep knowledge of forecasting models, processes and best practices• Unwavering commitment to objective data, information and insights to inform forecast assumptions• Ability to understand and interpret clinical data to shape assumptions about product opportunity and limitations• Compelling record of forecasting excellence and experience• Represent the Forecasting Center of Excellence with clarity of purpose, direction and value to the organization• Comfortable working in a dynamic and fast-paced environment• Strong communication skills with a keen ability to explain forecast assumptions and rationale clearly and concisely• Proven ability to navigate a matrix organization, manage stakeholder relationships, and collaborate with cross-functional partners.• Ability to influence stakeholders and senior management with sound logic and compelling narrative• Experience managing and developing agencies to support forecasting needs
ID
2018-10117
Category
Customer Insights & Business Analytics
Job Locations US-Remote Sales
We are a company that believes in performance excellence, which is based on a framework of Performance, Leadership, and Continuous Improvement. We will accelerate our sales growth through the leadership and development of our people to outperform the competition. Position Summary:The Renal Account Manager contributes to OAPI’s overall sales objective by performing assigned sales related activities. Provides hospitals, physicians, pharmacists and healthcare providers with products, services, and information that will enable them to use and prescribe OAPI products safely and effectively.We are looking for individuals who are highly motivated, learning agile, and can grow in a Commercial organization.Otsuka-people who:- Think differently by challenging conventional thinking- Are intellectually curious and life-long learners- Are effective, ’get it done’ and have a sense of ownership- Are comfortable with ambiguity, autonomy and recognize that innovation is at its best when people connect- Are remarkable in their chosen fieldKey Job Expectations/Responsibilities:- Ensures full compliance with drug laws, regulations, and OAPI policies in all aspects of interactions with healthcare professionals- Achieves the assigned sales objective for the territoryEffectively manages the formulary process to ensure product acceptance to assigned hospital accounts by establishing credibility with key hospital stakeholders, performing timely formulary review for products, expediting formulary acceptance of product, implementing effective plans for product pull-through, and organizing in-services to communicate appropriate approved product information to appropriate hospital personnel on all shifts- Attains the designated goals for calls on appropriate accounts and healthcare professionals- Communicates balanced, accurate, and complete information on OAPI products- Executes calls on pharmacists in order to provide product information and to ensure the availability of OAPI products in assigned accounts within the territory- Collaborates with market access team for formularies and product availability- Demonstrates consistent completion of all administrative requirements in a timely manner, including call reporting, budget management, log-ins, etc.- Completes all required training courses and continually updates product knowledge- Assists district manager in training new Renal l account managersCompliance Management:- Ensures full and complete compliance of all selling activities within the area of responsibility to OAPI standards and to all state and federal regulations- Complies with the letter and spirit of all state and federal laws, regulations, and guidance as well as PhRMA Code on Interactions with Healthcare Professionals and OAPI standards and policies relating to all promotional activities
ID
2018-10113
Category
Field Sales
Job Locations US-MD-Rockville
This role provides analytical and technical support, manages activities at contract laboratories, including analytical method validation/qualification, ID testing, release testing, stability testing, investigational testing. There is responsibility to develop, manage and monitor stability programs for commercial products, clinical trial materials, and developmental projects. The candidate will also review test results/raw data to ensure that results meet specifications, test procedures were followed, and laboratory work is documented appropriately. - Effectively manages contract laboratories with regards to quantitative and qualitative analytical testing of developmental, clinical, and commercial pharmaceutical and related products (including raw materials, in-process materials, and finished products) and reporting of results.- Reviews, interprets, and evaluates analytical data, including raw data, of developmental, clinical, and commercial pharmaceutical and related products for accuracy and compliance within Otsuka and GxP requirements.- Monitors stability studies of developmental, clinical, and commercial pharmaceutical and related products tested by contract laboratories.- Reviews, enters, and maintains stability data for developmental, clinical, and commercial pharmaceutical and related products.- Transfers analytical methods between Otsuka Japan, contract laboratories in the US, and other international affiliates.- Prepares and maintains QC documentation, including protocols, reports, and test methods.- Audits external analytical laboratories as subject matter expert.- Procures reference materials for contract analytical laboratories.- Writes/reviews CMC section of PMA, NDA and IND assuring completeness and accuracy- Maintains and updates department documents required for regulatory compliance - Assures testing requirements adherence to latest regulatory standards - Serve as a scientific liaison on selected development projects for quality control matters.- Lead technical investigations- Lead the selection of external labs- Manage vendor contracts
ID
2018-10112
Category
Technical Operations
Job Locations US-NJ-Princeton
The content writer reports to the manager of content development from the Ethics and Compliance (E&C) department. As a content writer, you will be responsible for designing and editing company policies, procedures, training materials, and other communications on multiple platforms and formats. The content writer collaborates with subject matter experts to develop documents to support the business. The content writer supports the subject matter experts by providing support with templates and development tools.  • Develops digital web-based versions of policies, procedures, and other supporting documents (e.g. job aids, templates, forms)• Oversees the E&C communications plan in collaboration with Otsuka’s communications department• Review and edit E&C documents (e.g. training, policies, procedures, communications) to ensure proper grammar, style, and formatting• Collaborates with business key stakeholders to develop company policies and procedures• Provides guidance and instruction on the use of policy and procedural templates to subject-matter-experts• Develop content for both the E&C intranet and internet sites• Develop documents in support of E&C training courses and curricula (e.g. course storyboards, course or curricula descriptions)
ID
2018-10111
Category
Compliance
Job Locations US-NJ-Princeton
Otsuka America Pharmaceuticals, Inc. (OAPI) is currently seeking a Total Rewards Benefits Analyst. In collaboration with the Sr. Total Rewards Partner, the Total Rewards Benefits Analyst provides functional subject matter expertise in support of the design and delivery of the company’s Total Rewards strategy. This position will support the administration of the company’s full suite of benefits offerings, including its health and welfare plans, retirement plans, and wellness programs. Assist in the overall design, administration, delivery and support of the organization’s employee benefits programs and related procedures to ensure successful adoption and compliance with all applicable laws Serve as benefits subject matter expert and liaison to the company’s benefits brokers, carriers and vendors. Additionally, serve as an internal benefits consultant and educator to employees, People Team and Business Partners Interpret and explain policy and coverage information, plan documents and other benefits-related topics and materials in easy to understand terms appropriate to his/her audience Support the annual benefits renewal and open enrollment processes, including plan and vendor evaluation, cost and utilization analyses, and data audit and reconciliation Coordinate benefits-related data requests and provision to ensure the timely and accurate submission of data for compliance, audit and reporting purposes. Assist in the development of impactful benefits-related HR Analytics, including ongoing reporting of dashboards and ad-hoc reports Ensure benefits programs and processes are documented and compliant with People team strategies, policies and governmental regulations. Ensure benefits-related documentation, supporting materials and communications are thoroughly reviewed for accuracy, updated in a timely manner and compliant with respective plan or governmental regulations Proactively collaborate with People Team and Business Partners in program delivery and other projects as assigned. Maintain clear understanding of the integration with other People and Finance workstreams (e.g. payroll, accounting, etc.) and the downward impact of benefits-related decisions and process changes Effectively manage vendor and third-party administrator relationships Continually evaluate existing benefits programs and processes; make recommendations for enhancements or improvements in support of strategic initiatives or as triggered by changes to available environments, regulation, technology or business needs. Plans, implements, and evaluates wellness programs; coordinates with key partners on programs, projects, and initiatives. 
ID
2018-10110
Category
Human Resources
Job Locations US-MD-Rockville
Can work out of Princeton, NJ or Rockville, MD office. Actively participates and contributes to the study design and reporting of Clinical Pharmacology studies. Provides input into all phases of drug development including, but not limited to, dose finding, dose optimization, exposure-response and pediatric development. Closely interacts with nonclinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies. Author of Clinical Pharmacology submission documents and representative of the department at different product development team meetings. Works closely with Pharmacometrics and Simulation and Modeling team members to provide input on modeling and simulation activities. - Development and review of protocol outlines, protocols, pre-study, during study and post-study clinical activities- PK and PK/PD study design, analysis and reporting, of PK and PK/PD studies.- Work with pharmacometricians on Population PK/PD design, analysis and reporting- Conduct PK/PD modeling and simulation - Update PK/PD development plans and the Clinical Pharmacology sections of Global Development & Commercialization Plans- Development of relevant sections for regulatory filings including Annual updates, IB updates, Investigational New Drugs and New Drug Applications- Works with Bioanalytical team members on:- Assay development, sample management and bioanalytical activities- Pharmacogenomics and pharmacogenetics activities- Selection and analysis of biomarkers- Works with formulation development groups with regard to:- Formulation development, dissolution testing, in vivo-in vitro correlations for pre- and post-approval formulations.- Manage outsourcing of PK and PK/PD analyses and reports, including contract requisition, SOW and approval of invoices- Training and mentoring of junior staff.- Compliant with SOPs, policies, and procedures- Reviewing processes and procedures and recommending changes, where necessary- Liaises with external functions and affiliates.- Supports corporate and departmental goals.- Serves as Clinical Pharmacology team member on multiple project teams and as a team member on other key projects as needed.Travel 20% 
ID
2018-10109
Category
Clinical Pharmacology
Job Locations US-NJ-Princeton
Reporting to the Director/Associate Director of Device Development and Technology, the Manager – Device Development is 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
ID
2018-10108
Category
Technical Operations

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