Global Labeling Process Excellence Lead
Company: Takeda Pharmaceutical
Posted on: August 7, 2022
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- The Global Labeling Process Excellence Lead is responsible for
operational oversight and leadership of Takeda s End to End
labeling processes and systems , to ensure connectivity with the
End to End labeling vision at Takeda.
- To lead Global labeling in adoption of new processes, tools and
practices that bring cross-functional teams together to understand,
document and simplify processes across teams.
- Is a leader both internally and externally, contributing to
cross-functional initiatives and influencing the field as
- Accountable for the d evelop ment , implement ation and
management of "best-in-class" Global Labeling by defining Global
Labeling processes, standards and governance, tools, and
- Drives iterative changes to the Global Labeling processes and
tools as appropriate in support of continuous improvement
strategies to optimize the Global Labeling End to End
- W ill provide decisions required and oversight to p rocess l
eads ( across labeling ), who are accountable to drive initial
process optimization and responsible to sustain and drive
continuous improvement post-implementation as well as defining and
implementing process metrics.
- Accountable for the development and implementation of
appropriate Labeling systems, processes and standards across Takeda
as appropriate .
- Measure, analyze, and evaluate existing processes to identify
gaps , perform cost benefit analysis, and identify improvement
opportunities and develop metrics with KPIs to measure critical
- Monitors emerging technologies and contributes to working teams
as appropriate to determine potential impact and opportunities for
- Develop and design documents including training manuals ,
process outlines, flowcharts, checklists, templates, and
- Facilitate process improvement meetings and workshops,
including business process reengineering sessions, brainstorming
sessions and various process improvement events.
- Identify, plan and implement multiple projects, studying ways
to make improvements to one or many steps to increase productivity,
reduce costs, time management and recommend solutions that align
with business priorities.
- Partner with Global Regulatory Affairs Training to drive the
delivery of training solutions for labeling .
- Drive delivery of training solutions for selected labeling
process aiming to achieve process excellence.
- Responsible for the development and maintenance of training
materials for Takeda s global and local labeling processes as well
as delivering training (in person , virtual and e-learning) ,
including on the job training and onboarding program . Responsible
for analy z ing / updating existing non- GxP training materials to
facilitate achievement of business objectives .
- Assist in collecting and addressing feedback from the global
and local user community, and helps ensure that this feedback is
incorporated into the non- training and / or global processes , as
- Coordinate with Global Regulatory Policy and Innovation
colleagues on improving and accelerating regulatory intelligence
systems, processes, and alerts improvements .
- Lead and support for development and execution on process
policy strategy regarding labeling and electronic labeling within
the US, EU, Japan, China, and emerging ma rkets.
- Support and lead GRA and R&D participation in US regional
committees to drive effective networking and representation to
ensure a one voice policy.
- Partner with Government/Public Affairs to understand and
monitor evolving trends for Access requirements regionally, work
with internal stakeholders to identify opportunities/threats and
advocate Takeda s positions externally.
- Maintain consistent oversight of deliverables. Keep GRA
management and all internal customers, partners and stakeholders
abreast of progress and provide interim updates on ongoing
activities and current initiatives. Ensure issues are escalated
when needed and encourage resolution at the appropriate level.
- Lead routine and ad hoc meetings within function and
cross-functionally. Presents to senior management as relevant.
- Responsible for demonstrating Takeda Leadership Behaviors.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Comprehensive understanding of the pharmaceutical industry
(e.g., clinical development, the prescription drug distribution
process, etc) , with a focu s on regulations and laws pertaining to
drug labeling and packaging.
- Strong understanding of US and EU drug regulations, EMA / FDA
structure and processes, and active/emerging issues regarding
regulatory labelin g .
- Comprehensive understanding of the processes for creation,
maintenance, and archiving of the Company Core Data Sheets, USPI,
EU PI, and other country labeling for submission
- Demonstrated ability to work across functions, regions and
- Enterprise 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 disti l complex issues and ideas down to simple
- Executive leadership presence and confidence
- Embraces and demonstrates a diversity and inclusion mindset and
role models these behaviors for the organizaiton
Decis ion-making and Autonomy
- Broad decision making responsibilities:
- Ability to make highly complex decisions that impact the
- Accountable for decision making for designated function
- Ability to seek diverse input from multiple constit uents and
stakeholders to drive innovative solutions
- Ability to incorporate feedback and ensure decisions are made
swiftly to yield flawless execution
- Accountable for designing and implementing vision and strategy
for designated scope
- Effectively navigates the changing external and internal
environment and leads others through change by creating and
inspiring and engaging workplace
- Ability to effective ly implement R&D s partnership
- Effectively represent Takeda in High-level negotiation s with
the ability to resolve conflict in a constructive manner
- Visionary and forward thinking with the ability to influence
and effectively drive organizational change and continuous
- Comfortable challenging the status quo and bringing forward
- Ability to take risks implementing innovative solutions,
accelerating time to market
- Ability to work in a global ecosystem (internal and external)
with a high degree of c om p l exity
- Breadth of knowledge required across therapeutic areas,
indications, and/or modalities
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS /MS - PhD, JD, MD, or equivalent strongly preferred. Proven
track record working with a major regulatory agency, specific
experience in government affairs or policy is also desired.
- Director : A minimum of 10 years of pharmaceutical industry or
related experience. This is inclusive of 5 years project
management, process design experience or a combination of 10 years
regulatory and/or related experience in both development and
- Associate Director : A minimum of 8 years o f pharmaceutical
industry experience . This is inclusive of 5 years regulatory
experience or a combination of 5 years regulatory and/or related
experience in both development and post-marketing phases.
- Excellent collaboration/relationship building, strong
influencing and negotiation skills, integrity and adaptability.
Outstanding written and oral communication skills as well as
managing and adhering to timelines. Proven success at stakeholder
engagement across organizational levels and boundaries.
- E xperience deploying implementing and maintaining c ontinuous
i mprovement programs. Strong analytical and problem-solving skills
required . Experience in training, transformation, Lean, Lean Six
Sigma Black Belt/Master Black Belt encouraged .
- Must be strong communicator, and ability to explain complex
issues, trends, and strategies to a wide range of stakeholders
- Must be strong leader that creates vision for group. Inspires
and motivates group. Takes stand on important issues in productive,
Base Salary Range: $156,800- $224,000, 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..... click apply for full job details
Keywords: Takeda Pharmaceutical, Brockton , Global Labeling Process Excellence Lead, Other , Brockton, Massachusetts
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