Medical Affairs PM

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Job details

Company overview

We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people's health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.

Responsibilities

1) In research projects led by companies, manage research projects and contribute to the creation of evidence according to the plan.

• In the research project, as a member of the study team, in the process of planning, budget management, execution, and publication of results, internal related departments (R & D headquarters, legal / compliance department, purchasing department, finance department, etc.), the US headquarters, and outside the company Collaborate with partners.
• In the research planning phase, develop a research timeline and budget plan, and lead the research feasibility assessment.
• In the start preparation phase, we will be in charge of a wide range of tasks such as vendor selection, facility selection, various contract creation, and internal regulation assessment, and promote the project so that the research start can be achieved on timeline. In the execution phase, manage the project to proceed as planned through vendor management, cost management, and schedule management. We will also strive to ensure the quality of research.
• Work to comply with compliance by conducting research based on ethical guidelines and various laws and regulations and guidelines while coordinating with related departments within the company.
• For US headquarters-led research, work with headquarters personnel to promote the project.

2) In collaboration with researchers and their research institutes, the US headquarters, and related departments within the company (Medical Affairs, R & D Headquarters, Legal and Compliance Department, etc.), while maintaining the independence of researchers and the neutrality of research. Manage and execute researcher-led research (IIS) support operations and support the creation of innovative evidence by Japanese researchers.

• Responsible for researchers / research institutes and US headquarters in collaboration with related departments throughout the entire process of supporting IIS applications, contracting adopted projects, providing research funds and research drugs / compounds, preparing for research start, conducting research, and reporting results. Coordinate / negotiate with other parties and manage / execute IIS support operations.
• In the field of cancer where research on new treatment methods is advancing, doctor-initiated clinical trials are also covered by the IIS support system, and if adopted by the examination, research funds and investigational drugs will be provided to provide future new cancer treatments. Support the development of law.
• Collaborate / collaborate with related departments within the company to creatively find solutions when introducing an unprecedented new research support system.
• Post the latest information on the IIS support system developed by the US headquarters worldwide on an external website, and provide detailed information on the system and procedures to researchers considering application in collaboration with related departments within the company. ..
• When making a research contract with a research institution to which a researcher belongs, prepare a draft contract, negotiate a contract, and conclude a contract.
• After starting the research, we will confirm the progress of the research (including the status of publication) based on the contract, arrange the provision of research drugs / compounds, and pay the research expenses according to the milestone.

Requirements

Salary

8 - 14 million yen

Location

Tokyo