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Are 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 globally
Be 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 goals
Manage, 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 IT
Measure 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 leadership
Leadership, 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 services
DIMENSIONS 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 plus
Leadership
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 same
Decision-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 standards
Interaction
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 stakeholders
Innovation
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 business
Complexity
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 budgets
EDUCATION, 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 reimbursement
More 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” in accordance with Takeda’s Hybrid and Remote Work policy
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EEO Statement
Takeda 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.
Boston, MA
Employee
Regular
Full time
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