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IT Business Partner, Global Regulatory Affairs (GRA)

Company: Takeda Pharmaceutical
Location: Newark
Posted on: November 23, 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 DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a IT Business Partner, Global Regulatory Affairs (GRA) in our Cambridge, MA office.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Here, you will be a vital contributor to our inspiring, bold mission.OBJECTIVES/PURPOSE:

  • RD Business Partnering: Lead, manage and collaborate and act as a single point of contact between Global Regulatory Affairs business BU's R&D functions and Development Technology Leadership. Drive harmonization and alignment within RD Technology.
  • RD Technology Strategy: Provide leadership and influence the business strategy of the Global Regulatory Affairs business and lead the Technology translation and operationalization by (applying existing, emerging and new IT & Digital standards).
  • Capability Development and Co-Creation - Drive business value across key development capabilities including Regulatory Operations, Regulatory CMC, Advertising & Promotion, Regulatory Policy & innovation, Global Labelling. Act as a trusted advisor to the business, with the ability to influence stakeholders at all levels to guide and co-create new capabilities that are directly relevant to BU's development growth strategy.
  • Operational responsibility - Drive and manage day-to-day RD GRA Technology operations and performance while also delivering committed portfolio of Commercial projects.ACCOUNTABILITIES:
    • Owns IT relationship with Global Regulatory Affairs function and is accountable for business outcomes enabled by technology & digital. Act as an advisor and leader in identifying and delivering relevant solutions that add business value.
    • Provide strategic technology leadership and will help shape and drive growth, innovation and differentiation across BU, while maintaining global alignment, through existing standards and emerging technology.
    • Collaborate and harmonize/align strategic approaches and the operationalization with other IT business partners within RD Technology to shape Technology vision and direction.Manage business demand
      • Coordinate with the relevant RD Business Process Experts to enable BU's core capabilities as well as other Global IT functions
      • Lead and maintain IT roadmaps in alignment with BU's strategic plans, ensuring those roadmaps are aligned in the region and globallyBe the best business partner and continue to build your business acumen
        • Understand the Takeda business, its geographies, its franchises, the disease states and the products and services provided
        • Influence and drive RD's strategy and roadmap definition, ensuring technology & digital are key enablers in the discussion. Be a technology evangelist
        • Manage the launch of new products and the established brand teams, proactively suggesting ways in which technology can maximize the value for society, our patients and Takeda
        • Align and lead the collaboration with the business leaders in your area. Understand and influence the business strategy. Understand specific business initiatives and goalsManage, influence and improve the solutions for business partners, customers and patients in order to optimize the best possible experience with Takeda
          • Expert and manage the IT solutions deployed in RD- both the development IT solutions and all IT technology that supports the user base
          • Manage to improve the end user experience by working relevant IT teams (for example, help improve onboarding/offboarding processes)Pro-active align with the IT organization (Key when acting as a single point of contact) so that the appropriate teams can be engaged correctly to deliver the best solutions
            • Network with and get to know the key team members across all IT functions (CTUX, UAMS, Enterprise Digital, Commercial, Corporate IT, Global Manufacturing and Supply, etc.) so that demand and solutions can be best coordinated, especially those areas not directly in the scope of commercial ITMeasure progress and stay within agreed budget
              • Lead the use relevant scorecards to monitor and manage progress across operations (end user experience), projects and budget
              • Take appropriate action to keep on track IT's commitments
              • Communicate progress within the business and IT
              • Present Development IT metrics to leadershipLeadership, Organizational and Team development
                • Manage what roles, responsibilities and sizing are needed to provide support to the business environment you support
                • Create a culture of agility, performance, and value in technology servicesDIMENSIONS AND ASPECTS:Technical/Functional (Line) Expertise
                  • Exceptional knowledge of existing and emerging digital technologies. - Understanding of online communities and key success factors for driving exceptional results
                  • An ability to develop, document and present simple Business documentation including Business Cases, Business Requirements, Technology Architecture and Project Plans
                  • Experience using and delivering Development technologies
                  • Up to date knowledge of emerging technologies
                  • Experience in digital design and digital coding a plusLeadership
                    • Ability to partner with stakeholders at all levels of the organization
                    • Proven ability to lead in a heavily matrix global organization
                    • A strategic mindset, able to capture business priorities and articulate those into Development solutions
                    • Able to clearly communicate and foster alignment
                    • Able to create a technology roadmap and to lead a matrix team towards this technology roadmap
                    • Acts like an owner by delivering results, creating value for our stakeholders (internals and externals)
                    • Inspire others to deliver Takeda's mission, demonstrate passion for the business and give people a reason to enjoy their work
                    • Develop self and support others' development to achieve their full potential
                    • Demonstrates Curiosity. Welcomes failure as a learning opportunity
                    • Has no issue speaking up and encourages the team to do the sameDecision-making and Autonomy
                      • Makes bold decisions/recommendations
                      • Feels comfortable operating alone, within the boundaries set by RD Technology's management
                      • Ability to develop solutions with a wide cross-functional team of colleagues and collaborate effectively
                      • Able to influence stakeholders in a matrix organization, with ability to ensure delivery and maintenance of Development solutions at all levels of the organization
                      • Brings solutions instead of problems. Challenges the status quo. Has the courage to take an unpopular stance and defend it
                      • Removes barriers to move faster. Experiments and adapts. Thrives under pressure and fast pace
                      • Has high performance standardsInteraction
                        • Able to clearly communicate and foster alignment across all levels of the organization
                        • Is required to build strong working partnerships with IT Business partners, Business Process Experts & Analytics & Insights Development IT Team
                        • Build strong cross-functional relationships with team members in: System Integrators, IT Business Partner, Enterprise Architects.
                        • Able to strongly influence around the utilization of commercial solutions with business partners and cross functional teams
                        • Strong ability to build external collaborations with industry partners and suppliers
                        • Develop and leverage relationships with stakeholders to appropriately stretch and impact Development IT's stakeholdersInnovation
                          • Tracks and shares external trends, best practices, or ideas and then brings them proactively to his/her business stakeholders
                          • Generates breakthrough solutions, and enables others to do the same
                          • Draws on unexpected or seemingly unrelated ways of thinking
                          • Generate new or unique solutions and embrace new ideas that help sustain our businessComplexity
                            • Day-to-day decisions regarding design, development and implementation of Development solutions
                            • Able to present issues and recommended solutions in a succinct manner to Global, Senior and Executive Management on a frequent basis
                            • Manage relationships with key external 3rd party suppliers
                            • Recommend and monitor spend for project budgetsEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
                              • Bachelor's degree in Business, Marketing, Computer Science or Engineering
                              • 7+ years of working experience managing development, regulatory affairs IT initiatives including large external service provider partnerships within Pharmaceutical and/or Biotech environment
                              • Minimum 7 years of information management and/or related work experience in Biotech/Pharmaceutical industry
                              • Understand and provide clarity and transparency of local Development needs
                              • Strong collaborating skills and experience in people management and skills development
                              • Strong development business acumen with knowledge of interdependencies that impact the organization
                              • Excellent communication skills (written and verbal) with ability to listen and influence stakeholders at all levels
                              • Demonstrated experience overseeing regulatory affairs solutions
                              • Proven track record of driving change in processes and organizations, while maintaining working relationships with key business customers.
                              • Passion for optimizing the customer / end-user experience.
                              • Strong knowledge of information management, data quality, data constraints and Governance Frameworks
                              • Versed in Risk management possessing ability to identify, analyze, track, manage and resolve risks issues that impact project
                              • Apply global solutions where possible and local solutions only when necessary
                              • Understands and coordinates all aspects of IT including end user experience (infrastructure and applications) in RD and is able to coordinate cross IT activities
                              • Experience with full software development life cycle in regulated environment (FDA, GxP, HIPAA, SOX, GDPR and other data privacy, computer system validation, a plus)
                              • Project management qualification or equivalent experience preferable
                              • Experience on large IT projects from start to end
                              • Expertise in budget planning and financial management.ADDITIONAL INFORMATION:
                                • Travel of up to 5% may be required from this position.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 posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seq.This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy#LI-KD1EEO 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, Newark , IT Business Partner, Global Regulatory Affairs (GRA), Other , Newark, New Jersey

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