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Utilize business, strategic, and analytical skills to perform tasks such as: financial modeling and analysis; operations and service strategy development, revenue growth; operational process and technology optimization; store labor planning and analysis; organizational design and assortment/inventory performance analysis.
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With a primary reporting relationship to the Chair of Medicine and a secondary reporting relationship to the Associate Dean/Chief Financial Officer for the School of Medicine, the Vice Chair and Director of Finance and Administration (VC and DFA) position serves as the key business leader for the Department of Medicine and senior advisor to the Chair and faculty leadership.
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The Associate Director-Operations is responsible for overseeing day-to-day manufacturing operations, strategic planning, performance metrics monitoring and KPI’s, budget and developing talent.
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Demonstrated experience with pharmaceutical drug development and the use of data analysis for strategy development, business process improvement, product launch planning, and integrated evidence generation required.
$183,000 - $280,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Drive continuous improvement by recommending, planning and implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management and Strategic Planning (RPM&SP) head.
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Join Takeda as an Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience where you will partner with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for program / product of medium complexity are established and maintained, and plans & directs the seamless execution of the GRT goals.
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As Associate Director, Global Regulatory Project Management and Strategic Planning, you will partner with the program Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and cross-functional submission working groups (SWG) meetings, to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy for moderately complex programs and submissions.
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Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required. You will report to Director, GRO Regulatory Project Management and be a part of the Global Regulatory Affairs Team.
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Drive decision-making processes and escalate issues, as needed, ensuring proactive planning is taking place to enable delivery of all regulatory milestones for assigned programs. You will also lead cross-functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for early to late-phase programs by providing effective Project Management leadership, oversight, direction and planning.
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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.
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U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. Advanced education or credentialing in regulatory affairs and project management preferred.
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This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy. Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support.
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The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risks, mitigation management (and proposed solutions to support decision-making) for assigned programs.
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Proactively lead teams to identify and recommend solutions to problems and pathways to overcome timeline concerns and barriers for strategy execution. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
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Ensure seamless alignment of operational plans with Global Project Management (GPM) team and Therapeutic Area Units (TAUs)/Business Units (BUs) asset strategies. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
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