Associate Director, Global Labeling
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 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 an Associate Director, Global Labeling Lead where
you will be responsible for the development, maintenance, and
implementation of Company Core Data Sheets (CCDS) in line with
international standards and guidelines. You will provide strategic
and tactical labeling expertise to teams while ensuring compliance
with applicable regulatory requirements.
You will serve as the regulatory expert for labeling on the Global
Regulatory Affairs subteam to ensure that regulatory labeling
requirements are met for assigned products.
How you will contribute:
Lead cross functional teams to develop and update CCDS and other
key global labeling documents (i.e. CCDS Working Team)
In coordination with Global Labeling Oversight Committee (GLOC)
Chair, manages review and approval of CCDS/resolution of labeling
issues with the relevant GLOC
Evaluate risks associated with CCDS content and implementation
strategies, develop mitigation plans, and appropriately escalate
issues to Global Labeling management and the Global Regulatory
Lead
Recommend strategies and labeling language for inclusion in key
product labels (US PI, EU SmPC, JPI, others as appropriate),
consistent with the overall product strategy and information in the
CCDS, when available.
Provide information to Global Labeling Compliance, as required, to
support internal and external (i.e. Regulatory Authority)
requirements and support audits/inspections as a labeling subject
matter expert
Liaise with US Labeling Operations and EU Labeling Operations to
ensure labeling objectives and timelines are met
Analyze relevant competitor labeling to ensure Takeda products have
competitive labeling possible; maintain awareness of recent
in-class approvals.
Remain current with global standards, initiative by regulatory
authorities related to the CCDS and labeling, and assure that
Takeda processes conform to regulatory requirements. Propose
actions as needed.
Prepare/lead training and information sessions with GRA and other
functional areas to increase understanding and compliance with
internal and external labeling expectations and optimal labeling
strategies.
Establish cross-functional relationships to ensure control and
continuous improvement of global labeling programs to meet business
needs and regulatory requirements.
Minimum Requirements/Qualifications:
BSc Degree, preferred. BA accepted. Advanced scientific degree
(MSc, PhD, or PharmD) preferred;
8+ years of pharmaceutical industry experience. This is inclusive
of 6 years of labeling experience or combination of 5+ years
regulatory and/or related experience.
Understanding of scientific principles and regulatory/quality
systems relevant to drug development.
Knowledge of global standards and regulations related to CCDS and
Product Labeling (US PI and EU SmPC experience required, other
regional labels also preferred).
Demonstrates problem-solving ability to analyze risk and make
appropriate recommendations/decisions.
Acceptable and independent skills in the area of regulatory affairs
such as understanding broad concepts within labeling and
implications across the organization and globally; proactively
identify issues; offers creative solutions and strategies,
including risk mitigation strategies.
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 "remote" in accordance
with Takeda's Hybrid and Remote Work policy.
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:
$149,100.00 - $234,300.00The 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 , Associate Director, Global Labeling, Executive , Trenton, Pennsylvania
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