Director, Global Regulatory Project Management, GI -
Company: Takeda Pharmaceutical
Location: New York
Posted on: April 26, 2024
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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 Privacy Notice and Terms of Use . I further attest
that all information I submit in my employment application is true
to the best of my knowledge. 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 -
Virtual U.S. Base Salary Range: $169,400.00 - $266,200.00 The
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
e mployee s may be eligible for s hort - t erm and/ or l ong- t erm
incentive s . 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
- Virtual Worker Type Employee Worker Sub-Type Regular Time Type
Full time #LI-Remote
Keywords: Takeda Pharmaceutical, Hoboken , Director, Global Regulatory Project Management, GI -, Executive , New York, New Jersey
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