Regulatory Chief of Staff, Head Regulatory Process Excellence

Company: Takeda Pharmaceutical
Location: Salem
Posted on: May 11, 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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as a Regulatory Chief of Staff, Head Regulatory Process Excellence where you will Work within the organization to advance the objectives and vision of the Head, Global Regulatory Operations. You will also ensure project management support and facilitation of the Regulatory Leadership Team with the coordination of the preparation of the meetings and tracking of required actions until completion. As part of the Global Regulatory Affairs team, you will report to the Head, Global Regulatory Operations and work with Senior Leadership to identify key opportunities for cross-functional optimization.OBJECTIVES/PURPOSE

• Work within the organization to advance the objectives and vision of the Head, Global Regulatory Operations
• Ensure project management support and facilitation of the Regulatory Leadership Team with the coordination of the preparation of the meetings and tracking of required actions until completion
• Serve as a strategic thought partner to the Head, Global Regulatory Operations with regard to problems, current and future initiatives, strategies, project management and budgets
• Monitor progress toward Regulatory's KPIs, intervening as necessary to ensure that Regulatory is on track to meet or exceed its performance targets. - Provides insight in evaluating overall Regulatory performance over time and for future planning
• Lead and successfully deliver multiple process optimization projects, such that the business achieves a step change in performance (productivity, efficiency, effectiveness). Works with Sr Leadership to identify key opportunities for cross-functional optimization. The role will require someone who is hands on and able to contribute both as a leader and as an individual contributor.
• Articulates the vision for Regulatory Process Excellence and -strategies and establishes a multi-year strategy and roadmap and translates these plans into tactical plans
• Successfully oversee, manage and deliver significant operational optimization improvements via people, process and technology using Project Management and process improvement methods in collaboration with stakeholders. -
• Foster and instill a process excellence mindset through educating, coaching and mentoring colleagues at all levels of the business in process improvement techniquesACCOUNTABILITIES
  • Work within the organization to advance the objectives and vision of the Head, Global Regulatory Operations
  • Ensure project management support and facilitation of the Regulatory Leadership Team with the coordination of the preparation of the meetings and tracking of required actions until completion
  • Serve as a strategic thought partner to the Head, Global Regulatory Operations with regard to problems, current and future initiatives, strategies, project management and budgets
  • Monitor progress toward Regulatory's Key Performance Indicators (KPIs), intervening as necessary to ensure that Regulatory is on track to meet or exceed its performance targets. - Provides insight in evaluating overall Regulatory performance over time and for future planning
  • Initiates, leads and successfully delivers multiple Regulatory Process optimization projects, such that the business achieves a step change in performance (productivity, efficiency, effectiveness).
  • Manages resourcing builds matrix teams and reports project status to stakeholders and Sr. Management on a regular basis
  • Develops and grows relationship with internal and external partners to facilitate ideation of opportunities for optimization, securing organizational sponsorship and to effectively implementation solutions
  • Expertly navigates uncharted territory where no process or precedent exists, while maintaining compliance with internal procedures and industry regulations (GxP)
  • Accountable for ensuring measures for accessing success are implemented and monitored.
  • Engages in strategic discussions and provides recommendations based on analysis with quantifiable opportunities to drive optimizationCORE ELEMENTS RELATED TO THIS ROLE
    • Requires significant subject matter expertise in both core development function (Clinical Development, Regulatory Affairs, Pharmacovigilance) & Project leadership experience given criticality of aligning cross-functional teams and driving process forwardDIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise
      • Comprehensive understanding of the pharmaceutical industry and 12+ years experience in one or more of the following areas: -clinical development operations, pharmacovigilance, regulatory affairs, or pharmaceutical supplies
      • Project-management expertise, demonstrated ability to lead multiple, complex projects from inception to close-out
        • Process Improvement expertise and experience (Six sigma, LEAN, and/or PMP certification or equivalent desirable)Leadership
          • Demonstrated ability to work across functions, regions and cultures
          • Functional level leadership with the ability to inspire, motivate and drive results
          • Outstanding 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 distil complex issues and ideas down to simple comprehensible terms
          • Demonstrates senior leadership presence and confidence
          • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
          • Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives.
          • Invests time in helping others to enhance their skills and perform at a higher levelDecision-making and Autonomy
            • Decision making responsibilities:
              • Provide input to highly complex decisions that impacts across functional areas
              • Accountable for decision making for designated function
              • Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
              • Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution -
              • Accountable for providing inception of and implementing vision and strategy for designated scopeInteraction
                • Expertly navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
                • Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
                • Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner
                • Ability to build strong relationships and collaborate effectively with other interfacing Takeda functionsInnovation
                  • Forward thinking with the ability to recommend, influence and implement 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
                  • Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
                  • Role models respect and inclusion, creating a culture that fosters innovationComplexity
                    • Ability to work in a global ecosystem (internal and external) with a high degree of complexity
                    • Deep expertise required
                    • Ability to see and understand broader, enterprise level perspective -EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: -
                      • Bachelor's degree or related experience is required. Scientific or closely -related field preferred; Advanced degree preferred
                      • 12+ years of - experience in the pharmaceutical/biotechnology industry with direct leadership experience in at least one of the following: clinical development, pharmacovigilance, regulatory affairs or clinical supplies
                      • Senior management experience in R&D operations or related field, leading and influencing senior-level management and key stakeholders
                      • Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
                      • Six sigma, LEAN, and/or PMP certification or equivalent desirable
                      • Direct experience in the pharmaceutical industry or related field required
                      • Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus
                      • Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
                      • Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.
                      • Health care business acumen with a comprehensive understanding of the pharmaceutical industryWhat Takeda can offer you:
                        • Comprehensive Healthcare: Medical, Dental, and Vision
                        • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
                        • Health & Wellness programs including onsite flu shots and health screenings
                        • Generous time off for vacation and the option to purchase additional vacation days
                        • Community Outreach Programs and company match of charitable contributions
                        • Family Planning Support
                        • Flexible Work Paths
                        • Tuition reimbursementEmpowering Our People to ShineLearn more at .No Phone Calls or Recruiters Please.#LI-LC1Location and Salary Information:
                          • This job posting excludes CO applicants.Effective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. - US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Salem , Regulatory Chief of Staff, Head Regulatory Process Excellence, Other , Salem, Massachusetts