Director, Global Labeling Operations
Company: Takeda Pharmaceutical
Location: Clifton
Posted on: January 19, 2023
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 a Director, Global Labeling Operations where you
will develop, implement, and oversee Takeda's US and EU Labeling
Operation Teams.
You will contribute internally and externally, to cross-functional
initiatives and influencing the field as applicable as part of the
Global Regulatory Affairs team. You will report to Head of Global
Labeling Operations and Excellence.
How you will contribute:
As Director, Labeling Operations you will establish and lead the
Global Labeling Operations function. This includes:
- Responsible for the Labeling Operations strategy to deliver
high quality submission labeling and artwork that meets regulatory
timelines and that is in compliance with US and EU (CP, MRP, and
DCP) artwork guidance and implementation timelines.
- Establish and lead the internal and external Labeling
Operations US and EU Teams.
- Responsible for the Labeling Operations strategy to deliver
high quality labeling artwork that meets regulatory timelines and
that is in compliance with US and EU (CP, MRP, and DCP) artwork
guidance and implementation timelines.
- Provide US and EU regulatory expertise and guidance to Global
Labeling, Global Supply Chain, Legal, Global Regulatory Strategy,
Commercial, and other internal stakeholders.
- Provide expert advice on current US and EU labeling
requirements, templates, tools, and Health Authority-issued
guidance.
- Provide guidance and oversight for EU labeling translations.
Oversee vendor performing artwork and translations activities on
behalf of Takeda:
- planning, assigning, and directing work via vendor
interface
- providing performance feedback to vendor(s)
- escalating non-performance or compliance issues via the
appropriate procedures and systems
- working with vendor management to ensure appropriate trained
staff to support Takeda programs
- Formulate regulatory labeling strategies for implementation of
US/EU new and revised prescribing/patient information and packaging
and timing relating to labeling revisions. Skills you will have:
- Embrace and demonstrate a diversity and inclusion mindset and
role models these behaviors for the organization
- Technical/Functional (Line) expertise (breadth and depth of
knowledge, application, and complexity of technical knowledge)
- Strong knowledge of business area, regulatory environment, and
ability to identify and proactively manage the interactions
necessary for achieving business goals and objectives
- Demonstrated knowledge of global health authorities,
regulations, product approval, labeling, and lifecycle processes
for major markets and of pharmaceutical and regulatory affairs
requirements and practices
- Project management abilities
- Leadership (vision, strategy and business alignment, people
management, communication, influencing others, managing
change)
- Demonstrated ability to work across functions, regions, and
cultures
- Enterprise level leadership with the ability to inspire,
motivate and drive results
- Excellent communicator, able to persuasively convey both ideas
and data, verbally and in writing
- Ability to distil complex issues and ideas down to simple
comprehensible terms
- Broad decision-making responsibilities:
- ability to make highly complex decisions that impact the
enterprise
- accountable for decision making for designated function
- ability to seek diverse input from multiple constituents and
stakeholders to drive innovative solutions
- ability to incorporate feedback and ensure decisions are made
swiftly to yield flawless execution
- Complexity (Products managed, mix of businesses, internal
and/or external business environment, cultural considerations)
- Ability to work in a global ecosystem (internal and external)
with a high degree of complexity
- Breadth of knowledge required across end-to-end labeling
process, functions, and stakeholders Minimum
Requirements/Qualifications:
- Bachelor's degree (or equivalent) required. Masters
preferred.
- 10+ years experience in Pharmaceutical or Medical Device
industry, with 8 years in Regulatory Affairs, labeling or quality
assurance/compliance.
- Must have a detailed understanding of pharmaceutical drug
development and global regulations pertaining to labeling
artwork
- Excellent knowledge of EU and US labeling requirements and
ability to communicate and strong operational regulatory and
business experience, including knowledge of regulations and
guidance governing drugs and biologics labeling in all phases of
development for US and/or EU (relevant to role)
- Preferred expertise in packaging regulations and processes
involved in the generation and review of labeling
artwork/mockup
- Knowledge of the requirements for artwork in US and/or EU
(relevant to role). Experience in the preparation and submission of
artwork using artwork management systems (e.g. BLUE, Webcenter)
beneficial
- Ability to proactively identify regulatory issues; offers
creative solutions and strategies, including risk mitigation
strategies.
- Expertise in labeling artwork, supply chain, Regulatory
Strategy, and commercial
- Knowledge of global guidance relevant to labeling, drug
development, and commercialization of prescription medicines 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
health screenings
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
contributions
- 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: $156,800- $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
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 , Director, Global Labeling Operations, Executive , Clifton, New Jersey
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