Tokyo,14.0M ～ 18.0M

You will be responsible for:

Development and implementation of medical strategy and tactics in alignment with cross-functional partners and global counterpart

Responsible in the launch preparation of on-going late stage project in collaboration with global medical affairs.

Strong leadership and contribution in the cross-functional launch team in independent manner is strongly expected

In collaboration with MSL manager, develop and maintain medical KOL lists and communication plan, which aligned with medical and cross-functional brand plan

Planning and implementation of MA events such as advisory board, medical educations,i.e.Stand-alone medical symposium, webinars, congress medical events and presentation, video and other medical activities

Planning and promotion of Company Sponsored Research (CSR) and Externally Sponsored Research (ESR), particularly Externally Sponsored Collaboration (ESC) to address unmet needs and barrier in standard of care in collaboration with Evidence Generation lead and HEOR. Utilizing PMS and other data source creatively to maximize evidence generation is highly expected.

In collaboration with Publication lead, drive high quality publications of aforementioned evidence generations, encore presentations, case reports.

Planning and implementing Patient Support Program (PSP) and Patient Medical Programs in collaboration with Patient Program, Patient Advocacy and other functions. Seek future opportunities to develop data from such PSP.

Working with MSL managers to collect unmet medical needs and potential needs through interviews with health professionals, preparing reports, and sharing them with related departments to further improve medical plan.

Providing education and lecture slide review with the aim of carrying out appropriate company activities and message

Develop publication plan in collaboration with Publication lead, Evidence Generation Lead, HEOR, R&D,PMS and drive execution.

Support Medical Communication (Medical Information) to develop FAQ and answers to unsolicited medical requests

Tokyo,12.0M ～ 15.0M

Key accountabilities

Project strategy and coordination
-Provides operational input into the clinical project strategy by providing expertise to develop the best operational and scientific strategy for the successful conduct of the project. Knowledgeable about and understands overall project and franchise strategy.
-Ensures the Clinical Development Plans are communicated throughout the Extended Clinical Team and the R&D Project Team and to ensure alignment with R&D global project strategy.
-Accountable for Clinical project performance to ensure it meets expectation with respect to timelines, quality and budget.
-Contributes to ensure harmonization of activities (operational strategy) in between studies within a program and transversally and across clinical projects/programs, as well as alignment between local and global.
-Manages the planning and feasibility of execution of the clinical study/project/program performed as part of the Clinical Development Plan.
-Develops the planning and drives execution of the clinical sections of the required regulatory submissions and communicates status updates (i.e. CTD, eBLA, PAI, and others as appropriate).
-Monitors projects’ progress and performance against strategic objectives and key performance indicators.
-Ensures proactive, timely reporting on progress of program management components of clinical trials, openly escalate issues that require input from and discussion with members of Clinical Management.


Communication/Interfaces
-Consolidates strategic communication at project/program level and maintains cross functional communication.
-Acts as an interface between the Extended Clinical and Clinical Teams and other enabling functions such as GRA, PSPV, CMQO, GMA, EPI, PPFP and GI, especially in the context of issues resolution.
-Ensures oversight of the CRO involved in the monitoring of the study.
-Ensures effective cross-regional communication to allow clinical teams to function efficiently to achieve global plans. Ensures top down/bottom-up communication.
-In collaboration with the GCDSE arranges scientific advisory boards, adjudication committees and experts committees, set up, follow-up, communication and manages partnership/alliance with experts.

Leadership
-Is a member of R&D project (including local), extended clinical, and clinical teams member for assigned projects.
-Actively engages in decision-making process with other stakeholders in GCD, providing input as needed to Head, GCD and Global Heads of clinical platforms.
-Provides guidance on best practices and lessons learned for operational execution of clinical trials. Facilitates operational issue resolution. Leads risk management initiatives for the clinical project to minimize negative impacts to team deliverables.
-Coordinates crisis management within clinical project/program and interface with Clinical platforms and beyond to define and implement action plan.
-In collaboration with team member’s manager, mentors team members to develop enhanced leadership skills such as consensus-building and conflict resolution. Encourages and supports team member empowerment. Is a trusted liaison for Clinical and other stakeholders across platforms and functions.

Budget
-Ensures appropriate project level capacity/resource planning and management in conjunction with other functions within GCD.
-Consolidates and review budget and resources allocation for clinical project/study activities through transversal reviews and interact with BO, FP and R&D Finance to ensure the Clinical budget and planning is accurate.
-Is accountable for tracking and monitoring the project/program budget with support of BO.

Learning/continuous improvement
-Supports innovation and entrepreneurial mindset such as clinical trial designs, digital methodologies and tools as well as organization within the clinical project/program.
-Establishes culture of continuous learning and improvement in the clinical project. Identifies process issues requiring resolution at the project level and proposes solutions.
-Identify opportunities for improving organizational processes to continue to drive organizational excellence
-Ensures that ‘lessons learned’ approach is built into the review and adoption of new approaches and methods.
-Stays abreast of advances in his/her area of expertise.

Tokyo,14.0M ～ 16.0M

Position Overview
?May serve as a Core member of the cross-functional PDM Project Team (region specific).
?Regional Regulatory Lead on Regulatory Project Teams.
?Regional Lead and may lead cross-functional /cross- regional Regulatory Submission Teams.
?Participates on other Sub teams, as applicable.
?Serves as contact with local Regulatory Authorities.
?Some positions at this grade level may partially or wholly include oversight of computerized systems.

Job Responsibilities
?Responsible for preparing and/or overseeing the preparation of technically complex regulatory CMC submissions which require extensive interaction with departments outside of Regulatory Affairs CMC for investigational and commercial products, in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include supplements and license renewals to clinical trial applications and marketing authorizations, and CTNs for assigned territories.
?Provides strategic regulatory CMC advice as appropriate.
?Oversees preparation and maintenance of country specific labeling and product packaging (region specific).
?Coordinate and facilitate development of regional Regulatory CMC strategy with affiliates for local meetings and interactions.
?Ensures up-to-date knowledge of regulatory CMC requirements and communicates relevant changes in regulatory information to project teams and senior management in a timely manner.
?Initiates local process improvements and contributes to local and / or global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or other departments.
?Plans, schedules and arranges own activities and those of direct reports (if applicable).