<職務内容>
The purpose of Pharmaceutical Project Management (PPM)role is to have overall responsibilities
for working with the leadership of the Global counterparts and the corresponding Affiliate Business
Unit functions to assure development and implementation of appropriate pharmaceutical
development strategies and plans from early-phase to end of the lifecycle of the molecule,as well
as to ensure that marketing and medical needs for the medical affairs activities are captured into a
single integrated local medical plan (LMP),on time and on budget in the relevant therapeutic
area.The key deliverables are full portfolio coverage,simultaneous development and launches,and
creating value across the entire product life stage.The role will be assigned to one or multiple
Therapeutic Areas (Immunology,Osteo-Neuroscience,Diabetes,or Oncology).
PRIMARY RESPONSIBILITIES:
●Align the Portfolio,Development and Medical Affairs Strategies to BU Strategies
・Engage Medical,Clinical,Regulatory,CMC/Manufacturing,Marketing,Safety Functions and
other functions to deliver the portfolio and align drug development /medical affairs
strategies with BU strategies.
・Provide leadership for development of Product Lifecycle Plan and Local Medical Plan (LMP)
in alignment with the Therapeutic Area development and commercial strategies.
・Deliver necessary information and data about the new/ongoing projects for the portfolio and
business plan management.
●Lead Value Maximization Through Product Lifecycle
・Lead to develop robust Japan Project Plan that fortifies linkages to Asset Profile,Value
proposition,MMFA (Manufactured Marketed Forms Agreement)and scope,assures quality
and consistency of content,and translates into operational objectives.
・Translate Japan marketing,medical and regulatory needs for the molecule/new
indication/line extension (including new formulation /delivery solution)into the global
integrated plan.
・Lead overall launch readiness and co-lead the affiliate overall launch readiness in
collaboration with respective commercial leader.
・Ensure post-marketing activities including issue management are managed well by
providing leadership to cross-functional collaboration.
Lead Development of Local Medical Plan (LMP)
・Be accountable for the overall planning and execution of the LMP,focusing on timeline,
resources,and other project management areas including feasibility of the solutions.
・Ensure alignment with Global Medical Plan for the overall strategy and timeline.
・Ensure that LMP is developed in alignment with other related business processes.
●Deliver Results
・Lead the team to meet or exceed overall project goals (completion of clinical studies,CMC
deliverables and NDA/device preparation,submission and approval timing,medical affairs
tactics,etc.)
・Deliver project milestones on time,on budget,within scope,and to high quality standards by
holding functions accountable for achievement of key project deliverables in alignment with
the agreed to project plan and in compliance with Japan quality standards.
・Identify areas for where process improvement will enable better results and work with
discipline leaders to impact change.
●Apply Project Management Knowledge and Processes
・Work with Japan governance to authorize project scope and plans.Scope and plans should
be based on broad scenario planning,robust risk management planning,and reliable execution (timeline,FTE,and budget)planning which ensures all functional requirements are
appropriately reflected.
・Develop and implement stakeholder,global,and team communication plan to ensure
alignment with medical affairs strategy and product development strategy.Lead external
communication strategy related to development (e.g.data read outs,regulatory
outcomes).Provide rapid and quality responses to external customers.
・Monitor and control performance of the overall project that utilizes appropriate tools and
techniques (project systems,budget:plan vs.actual,FTE:plan vs.actual,etc.),and ensure
change management process is in place to manage scope and plan.
●Build Winning Culture Through Effective People Management
・Coach team members by providing timely constructive feedback and recognition to good
results and behaviors.
・Create an environment that encourages intelligent risk taking and fosters wining culture
within the team.
・Support the growth of project management expertise in this company through participation in
shared learning forums,staff meetings and training programs.
●People Management
・PPM Manager may have direct reports (less than five)with line management responsibility
as below.
・Manage,develop,coach and mentor subordinates to maximize the performance and
growth.
・Build appropriate development plans and career plans.
・Create an environment that encourages intelligent risk taking and fosters winning culture.
・Support the growth of project management expertise in this company through participation in
shared learning forums,staff meetings and training.
・Accountable for that all staff adhere to current policies and procedures and are qualified
and trained to perform their responsibilities
<Knowledge and Skills>
・Strong leadership skills.
・Excellent interpersonal and communications skills both in Japanese (native,fluent,or
proficient)and in English (native,fluent,or proficient),communicate clearly with diverse
interpersonal styles and able to develop credibility cross functionally.
・Ability to influence others positively,negotiate effectively,and manage conflicts effectively.
・Ability to lead and deliver in the volatile,uncertain,complex,and ambiguous environment.
・Project Management Expertise
・Strong strategic and logical thinking skills.
・Strong conceptual skills.
・Understanding of Project Management concepts,tools,and skills.
・Business acumen.
<Education and Work Experience Desirable to Perform Role>
・A degree in healthcare,science or business discipline (BS/MS/PhD,MD,MBA).
・Experience in R&D function(s).
・English language proficiency required,or substantial experience as an active member or a
leader of a global team.
<Additional Preferences>
・Working experience in pharmaceutical industry.
・Drug development and medical affairs knowledge and expertise.
・Qualification in project management professional (PMP).
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