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Director, GRA Governance - Hybrid / Remote

Company: Takeda Pharmaceutical
Location: High Bridge
Posted on: November 21, 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 DescriptionThe Regulatory Governance Director is responsible for providing leadership, strategic thinking and expert execution of the Governance of global regulatory data, and associated information repositories serving Global Regulatory Affairs organization. Incumbent will partner with business stakeholders as well as liase with Takeda Regulatory Information Management and Regulatory Digital Innovation teams to ensure activities are implemented to plans with Information integrity and according to defined requirements and timelines.ACCOUNTABILITIES

  • Serves as the lead business owner of Regulatory Governance and associated processes and systems. Ensures information and data standards are aligned with Takeda's strategic business requirements (e.g. MDM, Regulatory strategy, Industry standards, HA expectations)
  • Leads a global team of leaders and regulatory solution professionals.
  • Global SME/Business owner on Data Governance.
  • Enforce and operationalize data governance standards
  • Understands strengths and weaknesses of different data governance model.
  • Connects with the right people to assess the current situation and propose the right strategy.
  • Assess the current data project portfolio, and advises on sequences of operations
  • Works as a team with counterparts in Data Sciences and R&D
  • Ensures there is oversight and governance of information and content up and downstream as well as across the governed regulatory systems portfolio.
  • Identify and lead governance related continuous improvement efforts within the regulatory solutions organization.
  • Demonstrates high level of leadership and expert understanding by applying interpersonal skills and expert RA knowledge to address and overcome challenges that arise.
  • Successfully communicates and negotiates with international Health Authorities as necessary, directly or indirectly
  • Ensures compliance and inspection readiness of regulatory solutions.
  • Ensures that the company's regulatory data are managed in accordance with external regulations and internal processes, are protected and controlled over the long term and that relevant information is available for critical business needs and is retained in accordance with established retention schedules.
  • Collaborates with other IM leaders to deliver value-add business facing services to improve system user experience, information accuracy and timeliness
  • Engage and lead with external regulatory forums and consortia on innovation related to solutions and information for the needs of Global Regulatory Affairs
  • Ensures Takeda portfolio support with appropriate SLAs and customer focus
  • Lead and define the development and execution of strategic and change management initiatives.
  • Oversees external vendor executing any regulatory governance activities including the development and oversight of robust KPIs.
  • Oversees and mentor direct reports, providing leadership and training to support professional development.
  • Responsible for demonstration of Takeda Leadership behaviors.Technical/Functional (Line) Expertise
    • Comprehensive understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc)Leadership
      • Demonstrated ability to work across functions, regions and cultures
      • Functional 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 distil complex issues and ideas down to simple comprehensible terms
      • Demonstrates 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 impact the functional area
          • 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 input to and implementing vision and strategy for designated scopeInteraction
            • Effectively 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.
                  • 10+ years of experience in Pharmaceutical industry, with 10 years in Regulatory Affairs, research and development, quality assurance/compliance.
                  • Demonstrated experience leading teams, managing and mentoring colleagues.
                  • Significant experience in global drug development regulations, regulatory submissions, lifecycle manage-ment, compliance, business systems technology and process is required.
                  • Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and industry forums, international experience preferred.
                  • Expert understanding of scientific principles and regulatory information standards/requirements relevant to global drug development and post-market support.
                  • Understanding in regulatory publishing and Information management tools is required.
                  • Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.
                  • Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
                  • Demonstrates high level of leadership, problem-solving ability, flexibility and teamwork.
                  • Exercises good judgement in elevating and communicating actual or potential issues to line management.
                  • Excellent written and oral communication skills required.
                  • Active participation in Agency/Industry groups/forums expected. Recognized as an expert in the field.What 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 reimbursementMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. 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.Base Salary Range: $160,300 - $229,000, 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, Tuition Reimbursement Program and Paid Volunteer Time Off. This position is currently classified as "hybrid" or "remote" in accordance with Takeda's Hybrid and Remote Work policy.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.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.LocationsUSA - MA - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time #LI-Remote

Keywords: Takeda Pharmaceutical, Bethlehem , Director, GRA Governance - Hybrid / Remote, Executive , High Bridge, Pennsylvania

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