Associate Director, Global Labeling
Company: Takeda Pharmaceutical
Location: Newark
Posted on: April 23, 2024
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 DescriptionAbout 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 SummaryWe
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-term incentives. 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 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.LocationsMassachusetts -
VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
#LI-Remote
Keywords: Takeda Pharmaceutical, New York , Associate Director, Global Labeling, Executive , Newark, New York
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