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US-NJ-Jersey City
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.   Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.   The Senior Director, Project Management is responsible for leading the Project Management Office (PMO) at MTDA which manages the resources, staff, integrated timelines and budgets for all drug development projects and also leads the implementation of Drug Development Management (DDM) Guidelines at MTDA and the other MTPG companies to ensure clear and efficient management of global drug development. The Senior Director, Project Management is also responsible for leading the Project/Product Approval Committee (PAC) Office. The PAC Office is the administrative office for the US PAC and is the interface body between Project Teams and the US PAC. The Senior Director, Project Management will ensure the development of global project plans in line with the product development objectives and corporate strategy, proactively identify and facilitate resolution of any potential deviation from the plan(s), identify and resolve resource issues, and identify risks to achieving key milestones as well as opportunities for acceleration. The Senior Director, Project Management works cross-functionally and collaboratively to support product development and life cycle management activities. Incumbent will provide guidance to project managers to ensure consistent and effective project management leadership of global drug development project teams, including providing technical and strategic guidance and expertise during reviews of project strategies and deliverables. The incumbent will contribute to the long-term strategy and development of the department and to the consistent execution of strategy to advance the MTDA portfolio.
ID
2018-1088
US-NJ-Jersey City
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.   Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.   The Staff Accountant, Expense Reimbursements supports all Mitsubishi Tanabe Pharma group companies in North America from an accounting standpoint with an emphasis on travel and other expense processing.
ID
2018-1084
US-NJ-Jersey City
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.   Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.   The Medical Writer will provide regulatory, nonclinical and clinical documents support to the clinical development programs.  The writer will ensure successful preparation of high quality, submission-ready documents and effective implementation of the convention-based medical writing process. Incumbent will provide expertise in the medical writing for multiple compounds and/or projects within the therapeutic area(s). Typical duties would include writing non-clinical and clinical CTD modules, study reports, protocols, executive summaries and briefing books.  Assisting the clinical development or regulatory team leads with generation of key preclinical and clinical reports and summaries.
ID
2018-1083
US-NJ-Jersey City
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America, we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.   Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.   The Talent Acquisition Manager will provide strategic leadership for Talent Acquisition, from the initial sourcing efforts for pharmaceutical professionals and throughout the full lifecycle process to point of hire and beyond. The incumbent will ensure the timely hiring of new recruits who are highly qualified, well-vetted and a good match to the company culture
ID
2018-1082
US-NJ-Jersey City
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.   Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.   The PV Audit Manager (P/T Consultant) will assist the Senior Director of QA, MTDA in the ongoing delivery of an integrated, coordinated and robust PV QA program.  Duties will touch upon all aspects related to the development and maintenance of an MTDA Quality system, including: SOPs, audits, inspection preparation, QA metrics, regulatory intelligence, process mapping, computer validation, etc. The consultant will also work collaboratively with the Manager of QA, MTDA to provide day-to-day assurance of: - Protection of Subjects - Veracity of Data - Legal Protection of Company This fixed-term 12-month consulting assignment offers a flexible 4-day per month schedule.
ID
2018-1080
US-NJ-Jersey City
The Senior Compliance Officer will support MTPC’s pharmaceutical businesses in the USA by providing providing compliance services and support primarily to MT-US. This is a dynamic role giving advice on compliance issues as they arise from the sales, market access, medical, operations, clinical, safety, regulatory, medical, sourcing, business development, research collaboration, and executive teams of MT-US. The incumbent will be involved in the creation and implementation of all aspects of the compliance programs for each entity and operate as part of cross-functional teams focused on ensuring compliance with all applicable laws, regulations, rules, and policies and procedures. The Senior Compliance Officer will be responsible for evaluating strategic and tactical compliance program plans and advising clients on a broad array of issues relating to company policies and procedures, FDA pharmaceutical regulations, GxP requirements, anti-kickback, off-label promotion, competitor, regulatory, medical, industry and group company issues. The position will also be responsible for overseeing the compliance programs at each of the entities, including annual risk assessments, annual work plans, compliance committees, company-wide policies and procedures, compliance communications, company-wide training and education, investigations, enforcement, and corrective actions, acting as the Compliance Officer for each entity.
ID
2018-1079
US-NJ-Jersey City
The Corporate Counsel, Clinical Development will provide legal services and support, primarily to Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), Mitsubishi Tanabe Pharma Holdings America, Inc. (MTHA) and their affiliated companies. This is a dynamic role giving advice on legal and compliance issues as they arise from the clinical, safety, regulatory, medical, sourcing and executive teams of MTDA, and the business development, and research collaboration teams of MTHA. Incumbent will be involved in all aspects of the development business and operate as part of cross-functional teams focused on developing pipeline products in the U.S. and acquiring or licensing products in the U.S. The attorney will be responsible for evaluating strategic and tactical research and development and business development plans, and advising clients on a broad array of issues relating to FDA pharmaceutical regulations, GxP requirements, product development, product labeling, non-promotional review, media materials, anti-trust, anti-kickback, competitor issues, compliance issues, regulatory policy, medical, industry and group company issues. The Corporate Counsel, Clinical Development will also be responsible for overseeing all contracts for MTDA and MTHA, including CRO agreements, clinical trial agreements, informed consent forms, consulting agreements, service agreements, supply agreements, and confidentiality agreements for MTDA, and development and license agreements, research collaboration agreements, terms sheets, consulting agreements, service agreements, and confidentiality agreements for MTHA.
ID
2018-1078
US-NJ-Jersey City
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.   Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.   Member of the Accounting department and supports all Mitsubishi Tanabe Pharma group companies in the North America from an accounting standpoint.
ID
2017-1074
US-NJ-Jersey City
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.   Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.   The Receptionist (Temporary Hire) manages the flow of calls, visitors, mail and deliveries at the company’s US Headquarters office, handling all interactions in a manner that upholds and promotes the company’s positive professional reputation. The incumbent also provides a range of administrative support and assists in developing and maintaining detailed administrative and procedural processes that reduce redundancy, improve accuracy and efficiency, and achieve organizational objectives.
ID
2017-1070
US-NJ-Jersey City
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.   Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.
ID
2017-1067
US-NJ-Jersey City
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.   Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy. The Clinical Finance Manager (Contractor) will manage all financial aspects of the Clinical Development Department, including project and trial costing, forecasting, reporting and analysis; budget creation/maintenance; and invoice management. This individual will work closely with Clinical Operations Team Leaders for various programs on a daily basis. This 6-month 40-hour per week contract role, which can be extended up to 18 months, is located at our Jersey City, NJ Headquarters.
ID
2017-1066
US-NJ-Jersey City
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America, we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.   Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.   The Mgr, Regulatory Affairs (Submissions) contributes to the strategic planning and preparation of regulatory submissions and supports the formatting, organization, and structuring of major regulatory submissions for his/her assigned products and/or therapeutic area(s) in collaboration with other departmental representatives.   Reporting to the Manager of Regulatory Operations, the Mgr, RA (Submissions) is responsible for the scheduling, timelines, follow-up, and preparation of all IND/NDA Annual Reports, Amendments, Briefing Documents and other periodic submissions in support of regulatory filings to regulatory agencies. Working closely with intra-departmental and cross-functional teams, he/she serves as an internal project manager for the submissions process to ensure that submissions are prepared in a compliant, high-quality fashion and within assigned timelines. The incumbent also oversees the document acquisition process and storage/filing of draft and final documents.  
ID
2017-1065
US-NJ-Jersey City
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.   Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.   Project Manager is an integral member of the Product Development Teams at Mitsubishi Tanabe Pharma Development America (MTDA). The Project Manager in collaboration with Project Leader and Team generates a comprehensive New Drug Integrated Development Strategy. The Project Manager is responsible for monitoring the execution of the Drug Development Project Goals on timeline, budget, scope, and quality goals. As a key member of the Development Teams, the Project Manager will seamlessly interact with Team members, functional area, and Project Approval Committee (PAC) for information sharing, issue escalation, and resolution. Project Manager will schedule and facilitate standing and ad hoc Team Meetings to facilitate discussion, decision and achieve project goals. Project manager is also responsible for updating the DDMS system on current status of project with regards timeline, resources, and budget. Additionally, the Project Manager will support the Head of the Department in a number of initiatives designed to enhance Project Management, PMO Office, and PAC Office at MTDA. Project Manager will assist in the generation of metrics, analytics, and reports to gain operational excellence in drug development across MTDA.
ID
2017-1060
US-NJ-Jersey City
Administrative Assistant (FT)   Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Holdings America, we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.   Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own Mitsubishi Tanabe Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.   Reporting to the President, the Administrative Assistant will provide a broad range of administrative support to ensure the smooth functioning of the department.
ID
2017-1059
US-NJ-Jersey City
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.   Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy. The Clinical Trial Manager (Contractor) will manage all operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring GCPs and relevant SOPs are met. The incumbent will manage study-related service providers and serve as the primary point of contact for contracted CROs, study staff and contract labs as appropriate; identifying potential risks and resolving issues with CROs; and ensuring study feasibility is performed as appropriate. The incumbant may also be called upon to help mentor or guide less-senior staff.
ID
2017-1056
US-NJ-Jersey City
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.   Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.   The Senior Drug Safety Specialist is responsible for completing all aspects of individual case safety report (ICSR) processing and reporting for assigned investigational and marketed products, while also assisting management in implementing departmental strategy. The Senior Drug Safety Specialist supports and participates in drug safety assessment and management. The Senior Drug Safety Specialist serves as a liaison to external service providers (i.e. clinical research organizations), investigational sites, and company personnel for safety-related issues, working in close collaboration with colleagues from Clinical Research, Data Science, Regulatory and Quality Assurance.
ID
2017-1054
US-NJ-Jersey City
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America, we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.   Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.   The Senior Director, Regulatory Affairs provides strategic regulatory guidance to cross-functional project teams responsible for product development and post marketing commitments.  He/she defines and implements global regulatory strategies, translating regulatory requirements into practical, workable plans in order to facilitate timely drug development and registration. The Senior Director, Regulatory Affairs works with cross-functional project teams to execute the agreed-upon strategies; interacts with regulatory agencies to negotiate agreements; coordinates the planning and conduct of regulatory agency meetings; and supports departmental activities with regards to clinical trial conduct and regulatory submissions.  
ID
2017-1028
US-NJ-Jersey City
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America, we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.   Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.   As a key member of our Clinical Development Team, the Medical Writer will provide regulatory documents support to the clinical teams, ensuring successful preparation of high quality, submission-ready documents and effective implementation of the clinical writing process. Incumbent will provide expertise in the medical writing for multiple compounds and/or projects within the therapeutic area(s). Typical duties would include substantive editing and review, researching and obtaining published reports on studies in a variety of different indications, writing executive summaries, and coordinating the publication of key preclinical and clinical scientific data through peer-reviewed journals and forums.
ID
2017-1020