Director, Global Labeling
Company: Takeda Pharmaceutical
Posted on: March 18, 2023
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that all information I submit in my employment application is true
to the best of my knowledge. Job Description 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
- Responsible for operational oversight and leadership for Takeda
Global Labeling (GL), including labeling vendors assigned to GL
responsibilities and tasks.
- Develops, implements, and oversees appropriate systems to
ensure compliance with external regulatory labeling requirements
and internal Takeda standards.
- Is a leader both internally and externally, contributing to
cross-functional initiatives and influencing the field as
- Provides leadership and development for direct reports,
including those that serve as global labeling leads responsible for
the design and execution of global labeling strategies in
collaboration with their regional counterparts. ACCOUNTABILITIES:
- Plans and manages CCDS (creation, maintenance, distribution,
tracking and implementation), US, and EU labeling processes in line
with strategic priorities and compliance with government
regulations/Takeda quality standards to ensure commercial product
- Establishes and manages relationships with labeling vendors to
ensure the effective implementation of labeling processes to meet
business needs and regulatory requirements.
- Monitors Local Operating Company (LOC) compliance with labeling
activities, takes corrective actions as needed
- Manages preparation of the Pharmacovigilance Site Master File
(PSMF) labeling sections, and inspection/audit activities
- Participates with influence in or leads departmental and
cross-functional task-forces and initiatives
- Identifies risks with mitigation plans and communicates with
Therapeutic Area Team Lead
- Serves as a labeling resource to the Therapeutic Area Units,
Marketed Products, and US/EU Labeling Operations as well as Local
Operating Companies for labeling issues
- Leads the development of new strategic and operational
initiatives to improve the efficiency of Global Labeling, US and EU
- Monitors industry labeling trends and proposes actions as
- Provides leadership to GL staff (including Takeda employees,
vendors, and partners) in establishing roles/responsibilities and
accountabilities across the labeling function(s).SCOPE OF
SUPERVISION:NUMBER SUPERVISED WORKERSDirect 0-8In-Direct
0-10EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BSc Degree, preferred. BA accepted. Advanced scientific degree
(MSc, PhD, or PharmD) preferred
- 10+ years of pharmaceutical industry experience. This is
inclusive of 8 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 the area of 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.
- Responsible for demonstrating Takeda leadership
- None required.PHYSICAL DEMANDS:
- Manual dexterity required to operate office equipment (i.e.
computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while
- Willingness to travel to various meetings, including overnight
- Requires approximately up to 10-30% travel.Base Salary Range:
$156,000 to $224,000, 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 seq 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
Keywords: Takeda Pharmaceutical, Rochester , Director, Global Labeling, Executive , Rochester, New York
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