Director, Operational & Systems Excellence
Company: Takeda Pharmaceutical
Location: Bronx
Posted on: May 12, 2022
Job Description:
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that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionAbout the role:At
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 Director, Operational & Systems
Excellence where you will lead a team that works across Global
Medical Affairs (GMA) Therapeutic Areas (TA) and functions ensuring
high-quality deliverables. You will also ensure a consistent
process and quality for evidence generation operations is
implemented across all therapeutic areas (TA). Oversee
administration and proper use of GMA-related research IT
system/digital applications, such as iEenvision, CTMS, Nexus, FMV
tools, and ensures compliance by collaborating with the appropriate
internal partners. Partner with Business Solutions & Analytics to
provide information to the business such as metrics and KPIs. You
will partner with the regions for training and disseminating
evidence generation operational excellence, which includes best
practice sharing. Support the development of evidence generation
policies and SOP trainings. As part of Global Medical Evidence, you
will report to Head, Global Medical Evidence and work with the
Global Medical Evidence team.How you will contribute:
- Oversees the development, implementation, administration and
proper use of processes, systems and tools to enable efficient and
compliant delivery, tracking, reporting and communication of Takeda
Medical Affairs evidence generation.
- Facilitates alignment with other business functions within the
organization, particularly the GPTs, Regions/BUs and R&D to
ensure consistency in understanding and implementing of asset level
research and data standards.
- Oversees processes, systems and activities related to data
curation and generation from a variety of internal and external
sources to ensure data are centrally maintained, managed and
available for stakeholders to access in real-time.
- Supports evidence generation planning and excellence by
development and implementation of tools, innovative approaches and
collaborations with other business functions.
- Support strategies and activities to ensure best practices are
maintained across evidence generation and integration activities
across TAs and Global, Regional and LOC Medical Affairs Units.
- Participate as a research functional expert on cross-functional
leadership teams.
- Ensure support is provided to audits and inspections as
applicable to medical evidence generation related IT
systems/digital application and processes.
- Deep understanding of regulations for real-world data in USA,
Europe and RoW
- Comprehensive understanding of the pharmaceutical industry and
Medical Affairs
- Global regulatory expertise with demonstrated ability for
collaboration and team leadership; experience leading and working
with cross-cultural teams.What you bring to Takeda:
- An advanced degree in a health sciences related field is
required, with PharmD, PhD or MD, or geographic equivalent,
preferred.
- 8 or more years in Medical Affairs, Clinical Research within a
biopharmaceutical industry setting.
- Experience leading teams in Medical Evidence Generation
Operations
- An understanding of research methodology and its application to
medical research planning.
- Experience with the key regulations worldwide governing
research in humans
- Superior communication, strategic, interpersonal and
negotiating skills
- Proactively predict issues and solve problems
- Drive decision-making within a multi-disciplinary,
multi-regional, matrix teams
- Diplomacy and positive influencing abilities
- Ability to drive or fly to various internal and external
meetings.
- Required travel approximately (10 - 20%), including
international trips, overnight stays, and some weekend
commitments.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.This position is
currently classified as "hybrid" in accordance with Takeda's Hybrid
and Remote Work policyIn accordance with the CO Equal Pay Act,
Colorado Applicants Are Not Permitted to Apply.
#LI-RMEEO 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, New Rochelle , Director, Operational & Systems Excellence, Executive , Bronx, New York
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