Director, Global Regulatory Project Management & Strategic Planning - Remote
Company: Takeda Pharmaceutical
Location: Jersey City
Posted on: June 18, 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 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 DescriptionACCOUNTABILITIES:
- Partner with the Global Regulatory Lead (GRL), co-lead and
facilitate product-specific Global Regulatory Team (GRT) meetings
and cross-functional major submission team meetings of high
complexity, to oversee, plan and deliver GRT goals and regulatory
submissions in accordance with regulatory strategy.
- Ensure Global Product Team (GPT) goals are cascaded and that
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 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 development and execution. Actively
contribute to the development, implementation and continuous
improvement of PM tools and processes for Global Regulatory Project
Management (GRPM) and R&D.
- Maintain lessons learned log across project portfolios; detect,
raise awareness and develop plan to address systemic
concerns/issues.
- Prepare and deliver reports and metrics on major regulatory
milestone status, potential critical issues, constraints,
bottlenecks, regulatory risk, mitigation management (and proposed
solutions to support decision-making) across individual programs,
and TAUs & BUs portfolios. Collaborate with the GRL in presenting
strategies and plan statuses to key stakeholders (e.g. GPT members,
Regulatory Leadership. TAUs & BUs) as appropriate, through both
scheduled and ad-hoc updates.
- Elevate high impact business critical issues and potential
critical issues together with proposed plan of action, as
appropriate, in a timely manner to management.
- Consult, support, advise and contribute to Takeda's body of
Project Management Knowledge and Project Management processes.
- Provide leadership and manage multifaceted business critical
projects and/or programs of very high complexity for departmental
initiatives and workstreams as assigned.
- Mentor staff including when applicable, direct reports, and
provide leadership and training to support their professional
development.
- Coach, train, and guide staff to excel in fulfilling all GRPM
responsibilities.
- Oversee both specific program as well as portfolio and TAU
RPM&SP deliverables. May create, lead and deliver reports and
efficient processes for portfolio assessments, reviews and planning
across the Therapeutic Area programs.
- 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.
Identify and resolve potential systemic bottlenecks and constraints
across the portfolio. .
- As necessary, drive continuous improvement across TAU GRTs by
planning and implementing changes through proactive engagements
with Regulatory management and Regulatory TAU heads.
- Liaise and interface with third party stakeholders to ensure
smooth and effective work flows.
- Responsible for demonstration of Takeda Leadership
behaviors.
- Represents Takeda at industry forums regarding project and
portfolio management is viewed internally/externally as an expert
in the field."This position is currently classified as "remote" in
accordance with Takeda's Hybrid and Remote Work policy."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.LocationsCambridge, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Jersey City , Director, Global Regulatory Project Management & Strategic Planning - Remote, Executive , Jersey City, New Jersey
Didn't find what you're looking for? Search again!
Loading more jobs...