At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
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).
1. 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.
2. 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.
4. 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.
5. 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.
6. 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 Lilly Japan through participation in shared learning forums, staff meetings and training programs.
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 Lilly Japan 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
Business Title:Associate/Sr Associate/Manager-Project Mgmt(IM)
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.
Education and Work Experience Desirable to Perform Role:
A degree in healthcare, science or business discipline (BS/MS/PhD, MD, MBA).
Minimum 3 years of experience in R&D function(s).
English language proficiency required, or substantial experience as an active member or a leader of a global team.
Working experience in pharmaceutical industry.
Drug development and medical affairs knowledge and expertise.
Qualification in project management professional (PMP).
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