Sr. Manager, Global Labeling (REMOTE)
Company: Takeda Pharmaceutical
Posted on: March 15, 2023
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application process with Takeda will commence and that the
information I provide in my application will be processed in line
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 four therapeutic areas and
other targeted investments, we push the boundaries of what is
possible to bring life-changing therapies to patients worldwide.
Join Takeda as a Sr Manager., Global Labeling (Remote) How you will
- Leads 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.
- Authors/manages outgoing communications regarding significant
labeling changes and CCDS changes for assigned products.
- Evaluates risks associated with CCDS content and implementation
strategies, develop mitigation plans, and appropriately escalate
issues to Global Labeling management and the Global Regulatory
- Recommends 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.
- Provides labeling strategy and guidance to Local Operating
Company (LOC) Regulatory, in collaboration with the RA Sub
- Provides 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.
- Liaises with US Labeling Operations and EU Labeling Operations
to ensure labeling objectives and timelines are met.
- Remains current with global standards and, initiatives by
regulatory authorities related to the CCDS and labeling, and
assures that Takeda processes conform to regulatory requirements.
Propose actions as needed.
- Identifies and leads initiatives, as requested, to enhance
Global Labeling processes and systems. Participates in training LOC
regulations on relevant labeling policies and procedures, as
needed. Prepares training materials as required. Minimum
- BSc Degree is preferred. BA accepted.
- Senior Manager: 6+ years of pharmaceutical industry experience.
This is inclusive of 5 years of labeling experience a combination
of 6+ years of 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).
- Strong oral and written communication, managing and adhering to
timelines, negotiation skills, integrity, and adaptability.
- Demonstrates problem-solving ability with the ability to
analyze risk and make appropriate recommendations/decisions.
- Must work well with others and within global teams.
- Acceptable and independent skills in regulatory affairs such as
understanding broad concepts within labeling and implications
across the organization and globally; proactively identifying
issues; offering creative solutions and strategies, including risk
mitigation strategies. What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and a company match of charitable
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement 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. Base Salary Range: $124,600 to $128,000,
based on the candidate's professional experience level. Employees
may also be eligible for Short-term and Long-Term Incentive
benefits as well. Employees are eligible to participate in Medical,
Dental, Vision, Life Insurance, 401(k), Charitable Contribution
Match, Holidays, Personal Days & Vacation, Tuition Reimbursement
Program, and Paid Volunteer Time Off. In accordance with the CO
Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. 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
Keywords: Takeda Pharmaceutical, Clifton , Sr. Manager, Global Labeling (REMOTE), Executive , Clifton, New Jersey
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