Director, Global Regulatory Project Management, GI -
Company: Takeda Pharmaceutical
Location: Trenton
Posted on: April 17, 2024
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Job Description:
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Job Description
About 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 three
therapeutic areas and other targeted investments, we push the
boundaries of what is possible in order to bring life-changing
therapies to patients worldwide.
Are you looking for a patient-focused, innovation-driven company
that will inspire you and empower you to shine? Join us as a
Director, Global Regulatory Project Management, GI - within our
Global Regulatory Affairs organization, based remotely.
OBJECTIVES/PURPOSE
Partners with the Global Regulatory Lead (GRL) on Global Regulatory
Teams (GRTs) to ensure global regulatory project plans for programs
/ products of high complexity are established and maintained, and
plans & directs the seamless execution of the GRT goals. Oversees
and provides regulatory operational support for programs in the GI2
Therapeutic Area Unit (TAU)
Expertly leads cross functional project submission working groups
(SWG) to deliver successful submissions/filings and outcomes with
Health Authorities (HA) for highly complex, novel, and critical
programs by providing expert and effective Project Management
leadership, oversight, direction and planning.
Directly supports GI - TAU Regulatory Head by ensuring project
management and regulatory operational support for the therapeutic
areas product portfolio is effective, seamless and delivering to
expectations. Generates and delivers reports on portfolio metrics
and status updates with actionable insights.
How you will contribute:
POSITION ACCOUNTABILITIES:
Partner with the Global Regulatory Lead (GRL), co-lead and
facilitate product-specific Global Regulatory Team (GRT) meetings
and cross-functional submission working groups (SWG) meetings , to
oversee, plan and deliver GRT goals and regulatory submissions in
accordance with regulatory strategy for highly complex
programs.
Partner with the GRL to ensure Global Product Team (GPT) regulatory
goals are cascaded and that the Global Regulatory Strategy Plan is
operationalized and executed upon. Ensure seamless alignment of
operational plans with Global Project Management (GPM) team and
Therapeutic Area Units (TAUs)/Business Units (BUs) asset
strategies.
Proactively drive GRT and SWG project teams, establish appropriate
level of urgency, and maintain focus on deliverables. Lead teams to
identify and recommend solutions to problems and pathways to
overcome barriers for strategy execution. Develop and maintain
integrated regulatory project plans and integrated SWG plans.
Directly support TAU Regulatory head with portfolio analytics by
creating, leading and delivering actionable assessment reports and
updates, as well as efficient processes for portfolio status
reviews. Provide project management support for TAU GRA department
meetings and project management leadership for business critical
projects and/or programs of very high complexity for TAU GRA
specific initiatives and workstreams as required/requested.
Provide and oversee regulatory operational support activities for
programs supported by the TAU. Ensure out-sourced regulatory
operational deliverables by third parties and vendors meet all
program timelines and company standards. Liaise and proactively
engage with third party stakeholders to ensure smooth, effective
and timely work flows. Operational support may include, but not
limited to drafting and preparation of forms and cover letters,
providing logistical support for health authority meetings,
coordinating briefing book roundtables, drafting regulatory
notifications, coordinating and managing regulatory document
workflows, inputting information into regulatory information
management systems etc.)
Prepare and deliver reports and metrics on major regulatory
milestone status, potential critical issues, constraints,
bottlenecks, regulatory risks, mitigation management (and proposed
solutions to support decision-making) across individual programs,
and across the TAU portfolio, as required. Collaborate with the GRL
in presenting operational strategies and plan statuses to key
stakeholders (e.g. GPT members, Regulatory Leadership. TAUs & BUs)
as appropriate, through both scheduled and ad-hoc updates.
Drive decision making processes and escalate issues, as needed,
ensuring proactive planning is taking place to enable delivery of
all regulatory milestones across the TAUs portfolio of
projects.
Elevate high impact business critical issues and potential critical
issues together with proposed plan of action, as appropriate, in a
timely manner to management.
Drive continuous improvement across TAU GRTs by planning and
implementing changes through proactive engagements with GRA TAU
head. Identify and propose solutions for addressing potential
systemic bottlenecks and constraints across the portfolio.
Supervise, coach and mentor staff. Provide leadership and training
to support Regulatory Project Managers' abilities to deliver on all
expectations and their professional development
Actively contribute to the development, implementation and
continuous improvement of PM tools and processes for Global
Regulatory Project Management and Strategic Planning (RPM&SP).
Maintain lessons learned log across project portfolios; track
project variances and identify root causes; detect, raise awareness
and develop plan to address systemic concerns/issues.
Consult, support, advise and contribute to Takeda's body of
Regulatory Project Management Knowledge and Project Management
processes.
Responsible for demonstration of Takeda Leadership behaviors.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Comprehensive understanding of the pharmaceutical industry and drug
development project management and regulatory affairs (e.g.,
clinical development, the prescription drug distribution process,
etc.)
Leadership
Demonstrated ability to work across functions, regions and
cultures
Functional 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 distil complex issues and ideas down to simple
comprehensible terms
Demonstrates 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 level
Decision-making and Autonomy
Decision making responsibilities: Provide input to highly complex
decisions that impact the functional area
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 input to and implementing vision and
strategy for designated scope
Interaction
Effectively 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 functions
Innovation
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
innovation
Complexity
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
Minimum Requirements/Qualifications:
Bachelors degree required. Emphasis in Science preferred. Advanced
degree preferred
10 years pharma experience with 8 years regulatory or 10 years
related field preferred
PMP certification or equivalent strongly preferred
Additional certification a plus: Regulatory (e.g. RAC or
equivalent), Change Management
Demonstrated expert experience leading high performance teams,
managing staff and mentoring colleagues.
Significant experience in global drug development regulations,
regulatory submissions, lifecycle management, compliance, business
systems technology and process is required.
At least 2 major (original or supplement) and several minor
(amendment) filing experiences in one or more jurisdictions, along
with eCTD experience is required.
Understanding of scientific principles and regulatory
standards/requirements relevant to global drug development and
post-market support.
Proven ability to provide regulatory operational support and
guidance.
Able to deal with issues of critical importance, provides
regulatory operational advice and making reasoned decisions on
regulatory operational issues.
Demonstrates leadership, problem-solving ability, flexibility and
teamwork.
Exercises good judgement in elevating and communicating actual or
potential issues to line management.
Active participation in Industry groups/forums expected. Recognized
as an expert in the field.
Excellent verbal and written communication skills and ability to
prepare effective presentations with focused messaging
Excellent interpersonal and negotiation skills
Demonstrates strong ability to collaboratively lead without line
authority, interact and work effectively with other departments as
well as external organizations
Excellent organizational skills, ability to multitask and with
attention to detail; capable of managing multiple projects within
assigned timelines
Ability to apply scientific principles to assess issues, request
and collect relevant information, analyze data, establish facts and
draw valid conclusions
Analytical and problem-solving skills with the ability to identify
issues and opportunities and provide direction to teams to explore
alternatives.
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.
This position is currently classified as "r" in accordance with
Takeda's Hybrid and Remote Work policy.
LOCATION & TRAVEL
Remote within the US
Travel: The Director is expected to come to Quarterly GRA meetings
in Cambridge & ad hoc travel, possibly international to Columbia,
Poland & India.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider
the next step in your career. We are committed to equitable pay for
all employees, and we strive to be more transparent with our pay
practices.
For Location:
Massachusetts - VirtualU.S. Base Salary Range:
$169,400.00 - $266,200.00The estimated salary range reflects an
anticipated range for this position. The actual base salary offered
may depend on a variety of factors, including the qualifications of
the individual applicant for the position, years of relevant
experience, specific and unique skills, level of education
attained, certifications or other professional licenses held, and
the location in which the applicant lives and/or from which they
will be performing the job. The actual base salary offered will be
in accordance with state or local minimum wage requirements for the
job location.
U.S. based employees may be eligible for short-term and/or
long-termincentives. U.S.based employees may be eligible to
participate in medical, dental, vision insurance, a 401(k) plan and
company match, short-term and long-term disability coverage, basic
life insurance, a tuition reimbursement program, paid volunteer
time off, company holidays, and well-being benefits, among others.
U.S.based employees are also eligible to receive, per calendar
year, up to 80 hours of sick time, and new hires are eligible to
accrue up to 120 hours of paid vacation.
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.
Locations
Massachusetts - VirtualWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time #LI-Remote
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Keywords: Takeda Pharmaceutical, Levittown , Director, Global Regulatory Project Management, GI -, Executive , Trenton, Pennsylvania
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