Director, Global Regulatory Project Management & Strategic Planning - Remote

Company: Takeda Pharmaceutical
Location: Jersey City
Posted on: June 18, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionACCOUNTABILITIES:

• Partner with the Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and cross-functional major submission team meetings of high complexity, to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy.
• Ensure Global Product Team (GPT) goals are cascaded and that Global Regulatory Strategy Plan is operationalized and executed upon. Ensure seamless alignment of operational plans with Global Project Management (GPM) team and Therapeutic Area Units (TAUs)/Business Units (BUs) asset strategies.
• Proactively drive project teams, establish appropriate level of urgency, and maintain focus on deliverables. Lead teams to identify and recommend solutions to problems and pathways to overcome barriers for strategy development and execution. Actively contribute to the development, implementation and continuous improvement of PM tools and processes for Global Regulatory Project Management (GRPM) and R&D.
• Maintain lessons learned log across project portfolios; detect, raise awareness and develop plan to address systemic concerns/issues.
• Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risk, mitigation management (and proposed solutions to support decision-making) across individual programs, and TAUs & BUs portfolios. Collaborate with the GRL in presenting strategies and plan statuses to key stakeholders (e.g. GPT members, Regulatory Leadership. TAUs & BUs) as appropriate, through both scheduled and ad-hoc updates.
• Elevate high impact business critical issues and potential critical issues together with proposed plan of action, as appropriate, in a timely manner to management.
• Consult, support, advise and contribute to Takeda's body of Project Management Knowledge and Project Management processes.
• Provide leadership and manage multifaceted business critical projects and/or programs of very high complexity for departmental initiatives and workstreams as assigned.
• Mentor staff including when applicable, direct reports, and provide leadership and training to support their professional development.
• Coach, train, and guide staff to excel in fulfilling all GRPM responsibilities.
• Oversee both specific program as well as portfolio and TAU RPM&SP deliverables. May create, lead and deliver reports and efficient processes for portfolio assessments, reviews and planning across the Therapeutic Area programs.
• Drive decision making processes and escalate issues, as needed, ensuring proactive planning is taking place to enable delivery of all regulatory milestones across the TAUs portfolio of projects. Identify and resolve potential systemic bottlenecks and constraints across the portfolio. .
• As necessary, drive continuous improvement across TAU GRTs by planning and implementing changes through proactive engagements with Regulatory management and Regulatory TAU heads.
• Liaise and interface with third party stakeholders to ensure smooth and effective work flows.
• Responsible for demonstration of Takeda Leadership behaviors.
• Represents Takeda at industry forums regarding project and portfolio management is viewed internally/externally as an expert in the field."This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy."EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsCambridge, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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