Sr. Manager, Global Labeling (REMOTE)
Company: Takeda Pharmaceutical
Posted on: November 25, 2022
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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 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 Sr Manager., Global Labeling (Remote)
How you will contribute:
- 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, develops mitigation plans, and appropriately escalates
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, 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
regulatory on relevant labeling policies and procedures, as needed.
Prepares training materials as required. Minimum
- BSc Degree, preferred. BA accepted.
- Senior Manager: 6+ years of pharmaceutical industry experience.
This is inclusive of 5 years of labeling experience or combination
of 6+ 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).
- Strong oral and written communications, managing and adhering
to timelines, negotiation skills, integrity and adaptability.
- Demonstrates problem-solving ability with 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 identifies
issues; offers 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 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. In accordance with
the CO Equal Pay Act, Colorado Applicants Are Not Permitted to
Apply. Base Salary Range: $124,600 to $128,000, based on candidate
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. This posting is made in compliance with Colorado's Equal Pay
for Equal Work Act, C.R.S. - 8-5-101 et seqEEO 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, Salem , Sr. Manager, Global Labeling (REMOTE), Executive , Salem, Massachusetts
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