Regulatory Chief of Staff, Head Regulatory Process Excellence
Company: Takeda Pharmaceutical
Location: Salem
Posted on: May 11, 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 and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionAt 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
Regulatory Chief of Staff, Head Regulatory Process Excellence where
you will Work within the organization to advance the objectives and
vision of the Head, Global Regulatory Operations. You will also
ensure project management support and facilitation of the
Regulatory Leadership Team with the coordination of the preparation
of the meetings and tracking of required actions until completion.
As part of the Global Regulatory Affairs team, you will report to
the Head, Global Regulatory Operations and work with Senior
Leadership to identify key opportunities for cross-functional
optimization.OBJECTIVES/PURPOSE
- Work within the organization to advance the objectives and
vision of the Head, Global Regulatory Operations
- Ensure project management support and facilitation of the
Regulatory Leadership Team with the coordination of the preparation
of the meetings and tracking of required actions until
completion
- Serve as a strategic thought partner to the Head, Global
Regulatory Operations with regard to problems, current and future
initiatives, strategies, project management and budgets
- Monitor progress toward Regulatory's KPIs, intervening as
necessary to ensure that Regulatory is on track to meet or exceed
its performance targets. - Provides insight in evaluating overall
Regulatory performance over time and for future planning
- Lead and successfully deliver multiple process optimization
projects, such that the business achieves a step change in
performance (productivity, efficiency, effectiveness). Works with
Sr Leadership to identify key opportunities for cross-functional
optimization. The role will require someone who is hands on and
able to contribute both as a leader and as an individual
contributor.
- Articulates the vision for Regulatory Process Excellence and
-strategies and establishes a multi-year strategy and roadmap and
translates these plans into tactical plans
- Successfully oversee, manage and deliver significant
operational optimization improvements via people, process and
technology using Project Management and process improvement methods
in collaboration with stakeholders. -
- Foster and instill a process excellence mindset through
educating, coaching and mentoring colleagues at all levels of the
business in process improvement techniquesACCOUNTABILITIES
- Work within the organization to advance the objectives and
vision of the Head, Global Regulatory Operations
- Ensure project management support and facilitation of the
Regulatory Leadership Team with the coordination of the preparation
of the meetings and tracking of required actions until
completion
- Serve as a strategic thought partner to the Head, Global
Regulatory Operations with regard to problems, current and future
initiatives, strategies, project management and budgets
- Monitor progress toward Regulatory's Key Performance Indicators
(KPIs), intervening as necessary to ensure that Regulatory is on
track to meet or exceed its performance targets. - Provides insight
in evaluating overall Regulatory performance over time and for
future planning
- Initiates, leads and successfully delivers multiple Regulatory
Process optimization projects, such that the business achieves a
step change in performance (productivity, efficiency,
effectiveness).
- Manages resourcing builds matrix teams and reports project
status to stakeholders and Sr. Management on a regular basis
- Develops and grows relationship with internal and external
partners to facilitate ideation of opportunities for optimization,
securing organizational sponsorship and to effectively
implementation solutions
- Expertly navigates uncharted territory where no process or
precedent exists, while maintaining compliance with internal
procedures and industry regulations (GxP)
- Accountable for ensuring measures for accessing success are
implemented and monitored.
- Engages in strategic discussions and provides recommendations
based on analysis with quantifiable opportunities to drive
optimizationCORE ELEMENTS RELATED TO THIS ROLE
- Requires significant subject matter expertise in both core
development function (Clinical Development, Regulatory Affairs,
Pharmacovigilance) & Project leadership experience given
criticality of aligning cross-functional teams and driving process
forwardDIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise
- Comprehensive understanding of the pharmaceutical industry and
12+ years experience in one or more of the following areas:
-clinical development operations, pharmacovigilance, regulatory
affairs, or pharmaceutical supplies
- Project-management expertise, demonstrated ability to lead
multiple, complex projects from inception to close-out
- Process Improvement expertise and experience (Six sigma, LEAN,
and/or PMP certification or equivalent desirable)Leadership
- Demonstrated ability to work across functions, regions and
cultures
- Functional level leadership with the ability to inspire,
motivate and drive results
- Outstanding 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 senior 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 impacts across
functional areas
- 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 inception of and implementing vision
and strategy for designated scopeInteraction
- Expertly 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; Advanced degree preferred
- 12+ years of - experience in the pharmaceutical/biotechnology
industry with direct leadership experience in at least one of the
following: clinical development, pharmacovigilance, regulatory
affairs or clinical supplies
- Senior management experience in R&D operations or related
field, leading and influencing senior-level management and key
stakeholders
- Proven track record of leading and driving business process
transformation and organizational culture change as well as
delivering on programs with complex business deliverables
- Six sigma, LEAN, and/or PMP certification or equivalent
desirable
- Direct experience in the pharmaceutical industry or related
field required
- Previous experience leading a medium to large organization and
influencing senior-level management and key stakeholders is a
plus
- Proven track record of leading and driving business process
transformation and organizational culture change as well as
delivering on programs with complex business deliverables
- Track record of successful leadership, management, and
development of large, multi-disciplinary globally dispersed teams.
Strong judge of talent with the ability to make tough talent
decisions.
- Health care business acumen with a comprehensive understanding
of the pharmaceutical industryWhat 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 reimbursementEmpowering Our People to ShineLearn more
at .No Phone Calls or Recruiters Please.#LI-LC1Location and Salary
Information:
- This job posting excludes CO applicants.Effective November 1,
2021, absent an approved religious or medical reason, all US
office-based and lab-based Takeda employees who work fully on-site
or in a hybrid model (as determined by Takeda) must be fully
vaccinated to work at a Takeda site or to engage with Takeda
colleagues or anyone else on behalf of Takeda. As of the same date,
absent an approved religious or medical reason, US field-based
employees, employees must be fully vaccinated in order to continue
in their current roles. - US employees who work at a Takeda
manufacturing facility, and those who work at a BioLife center or
BioLife lab, may be subject to different guidelines. Candidates are
encouraged to speak with their recruiter to seek further
information on the applicable guidelines for the Business
Unit/Function for which they have applied.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.LocationsBoston, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Salem , Regulatory Chief of Staff, Head Regulatory Process Excellence, Other , Salem, Massachusetts
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