Global Labeling Process Excellence Lead

Company: Takeda Pharmaceutical
Location: Brockton
Posted on: August 7, 2022

Job Description:

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Job Description

OBJECTIVES/ PURPOSE

• The Global Labeling Process Excellence Lead is responsible for operational oversight and leadership of Takeda s End to End labeling processes and systems , to ensure connectivity with the End to End labeling vision at Takeda.
• To lead Global labeling in adoption of new processes, tools and practices that bring cross-functional teams together to understand, document and simplify processes across teams.
• Is a leader both internally and externally, contributing to cross-functional initiatives and influencing the field as applicable.
  A CCOUNTABILITIES
  • Accountable for the d evelop ment , implement ation and management of "best-in-class" Global Labeling by defining Global Labeling processes, standards and governance, tools, and methodology.
  • Drives iterative changes to the Global Labeling processes and tools as appropriate in support of continuous improvement strategies to optimize the Global Labeling End to End Processes
  • W ill provide decisions required and oversight to p rocess l eads ( across labeling ), who are accountable to drive initial process optimization and responsible to sustain and drive continuous improvement post-implementation as well as defining and implementing process metrics.
    
    Process Optimization
    • Accountable for the development and implementation of appropriate Labeling systems, processes and standards across Takeda as appropriate .
    • Measure, analyze, and evaluate existing processes to identify gaps , perform cost benefit analysis, and identify improvement opportunities and develop metrics with KPIs to measure critical success factors.
    • Monitors emerging technologies and contributes to working teams as appropriate to determine potential impact and opportunities for Global Labeling.
    • Develop and design documents including training manuals , process outlines, flowcharts, checklists, templates, and implementation procedures.
    • Facilitate process improvement meetings and workshops, including business process reengineering sessions, brainstorming sessions and various process improvement events.
    • Identify, plan and implement multiple projects, studying ways to make improvements to one or many steps to increase productivity, reduce costs, time management and recommend solutions that align with business priorities.
      
      Training
      • Partner with Global Regulatory Affairs Training to drive the delivery of training solutions for labeling .
      • Drive delivery of training solutions for selected labeling process aiming to achieve process excellence.
      • Responsible for the development and maintenance of training materials for Takeda s global and local labeling processes as well as delivering training (in person , virtual and e-learning) , including on the job training and onboarding program . Responsible for analy z ing / updating existing non- GxP training materials to facilitate achievement of business objectives .
      • Assist in collecting and addressing feedback from the global and local user community, and helps ensure that this feedback is incorporated into the non- training and / or global processes , as appropriate.
      • Coordinate with Global Regulatory Policy and Innovation colleagues on improving and accelerating regulatory intelligence systems, processes, and alerts improvements .
      • Lead and support for development and execution on process policy strategy regarding labeling and electronic labeling within the US, EU, Japan, China, and emerging ma rkets.
      • Support and lead GRA and R&D participation in US regional committees to drive effective networking and representation to ensure a one voice policy.
      • Partner with Government/Public Affairs to understand and monitor evolving trends for Access requirements regionally, work with internal stakeholders to identify opportunities/threats and advocate Takeda s positions externally.
      • Maintain consistent oversight of deliverables. Keep GRA management and all internal customers, partners and stakeholders abreast of progress and provide interim updates on ongoing activities and current initiatives. Ensure issues are escalated when needed and encourage resolution at the appropriate level.
      • Lead routine and ad hoc meetings within function and cross-functionally. Presents to senior management as relevant.
      • Responsible for demonstrating Takeda Leadership Behaviors.
        DIMENSIONS AND ASPECTS
        
        Technical/Functional (Line) Expertise
        • Comprehensive understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc) , with a focu s on regulations and laws pertaining to drug labeling and packaging.
        • Strong understanding of US and EU drug regulations, EMA / FDA structure and processes, and active/emerging issues regarding regulatory labelin g .
        • Comprehensive understanding of the processes for creation, maintenance, and archiving of the Company Core Data Sheets, USPI, EU PI, and other country labeling for submission
          
          Leadership
          • Demonstrated ability to work across functions, regions and cultures
          • Enterprise level leadership with the ability to inspire, motivate and drive results
          • Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
          • Proven skills as an effective team player who can engender credibility and confidence within and outside the company
          • Ability to disti l complex issues and ideas down to simple comprehensible terms
          • Executive leadership presence and confidence
          • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organizaiton
            
            Decis ion-making and Autonomy
            • Broad decision making responsibilities:
              • Ability to make highly complex decisions that impact the enterprise
              • Accountable for decision making for designated function
              • Ability to seek diverse input from multiple constit uents and stakeholders to drive innovative solutions
              • Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution
                • Accountable for designing and implementing vision and strategy for designated scope
                  
                  Interaction
                  • Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
                  • Ability to effective ly implement R&D s partnership strategy
                  • Effectively represent Takeda in High-level negotiation s with the ability to resolve conflict in a constructive manner
                    
                    Innovation
                    • Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation
                    • Comfortable challenging the status quo and bringing forward innovative solutions
                    • Ability to take risks implementing innovative solutions, accelerating time to market
                      
                      Complexity
                      • Ability to work in a global ecosystem (internal and external) with a high degree of c om p l exity
                      • Breadth of knowledge required across therapeutic areas, indications, and/or modalities
                        EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
                        • BS /MS - PhD, JD, MD, or equivalent strongly preferred. Proven track record working with a major regulatory agency, specific experience in government affairs or policy is also desired.
                        • Director : A minimum of 10 years of pharmaceutical industry or related experience. This is inclusive of 5 years project management, process design experience or a combination of 10 years regulatory and/or related experience in both development and post-marketing phases.
                        • Associate Director : A minimum of 8 years o f pharmaceutical industry experience . This is inclusive of 5 years regulatory experience or a combination of 5 years regulatory and/or related experience in both development and post-marketing phases.
                        • Excellent collaboration/relationship building, strong influencing and negotiation skills, integrity and adaptability. Outstanding written and oral communication skills as well as managing and adhering to timelines. Proven success at stakeholder engagement across organizational levels and boundaries.
                        • E xperience deploying implementing and maintaining c ontinuous i mprovement programs. Strong analytical and problem-solving skills required . Experience in training, transformation, Lean, Lean Six Sigma Black Belt/Master Black Belt encouraged .
                        • Must be strong communicator, and ability to explain complex issues, trends, and strategies to a wide range of stakeholders
                        • Must be strong leader that creates vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way.
                          Base Salary Range: $156,800- $224,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation..... click apply for full job details

Keywords: Takeda Pharmaceutical, Brockton , Global Labeling Process Excellence Lead, Other , Brockton, Massachusetts