Sr. Manager/Associate Director, Global Labeling (REMOTE)
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: May 12, 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 DescriptionAre you looking for a
patient-focused company that will inspire you and support your
career? If so, be empowered to take charge of your future at
Takeda. Join us as a Senior Manager/Associate Director, Global
Labeling. This position is remote.Here, everyone matters and you
will be a vital contributor to our inspiring, bold mission. As
Senior Manager/Associate Director, Global Labeling working on the
Research and Development team, you will be empowered to take
responsibility for the development, maintenance, and implementation
of Company Core Data Sheets (CCDS) in line with international
standards and guidelines. A typical will include:POSITION
- Responsible for the development, maintenance, and
implementation of Company Core Data Sheets (CCDS) in line with
international standards and guidelines.
- Provide strategic and tactical labeling expertise to teams
while ensuring compliance with applicable regulatory
- Serve as the regulatory expert for labeling on the global
Regulatory Affairs (RA) Sub team to ensure that regulatory labeling
requirements are met for assigned products.
- 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 asEDUCATION, EXPERIENCE AND SKILLS:
- 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.
- Associate Director: 8+ years of pharmaceutical industry
experience. This is inclusive of 6 years of labeling experience or
combination of 8+ 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
- Willingness to travel to various meetings, including overnight
- Requires approximately up to 10-30% travelWHAT TAKEDA CAN OFFER
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs#LI-KD1Absent an approved religious
or medical reason, all US office-based and lab-based Takeda
employees who work fully on-site or in a hybrid model (as
determined by Takeda) must be fully vaccinated to work at a Takeda
site or to engage with Takeda colleagues or anyone else on behalf
of Takeda. US field-based employees must be fully vaccinated as a
condition of employment, absent an approved religious or medical
reason. US employees who work at a Takeda manufacturing facility,
and those who work at a BioLife center or BioLife lab, may be
subject to different guidelines. If you are contacted by a Takeda
recruiter about your job application, we encourage you to seek more
information on the applicable guidelines for the Business
Unit/Function to which you have applied.Location and Salary
- Post Role Location(s)
- Base Salary Range (Senior Manager): $130,000.00 - $155,000.00
for Senior Manager based on candidate professional experience
level. Employee may also be eligible for Short Term and/or Long
Term incentive benefits. Employees are eligible to participate in
Medical, Dental. Vision, Life Insurance, 401(k), Charitable
Contribution Match, Company Holidays, Personal & Vacation Days,
Student Loan Repayment Program and Paid Volunteer Time Off
- Base Salary Range: $160,000.00 - $185,000.00 for Associate
Director based on candidate professional experience level. Employee
may also be eligible for Short Term and/or Long Term incentive
benefits. Employees are eligible to participate in Medical, Dental.
Vision, Life Insurance, 401(k), Charitable Contribution Match,
Company Holidays, Personal & Vacation Days, Student Loan Repayment
Program and Paid Volunteer Time Off
- If candidate is not eligible for any benefits or other comp.,
those can be excluded
- In accordance with the CO Equal Pay Act, Colorado Applicants
Are Not Permitted to Apply.Preference will be given to candidates
with a remote location near, and availability to work during the
working hours of, the corporate office in Boston,
Massachusetts.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
Keywords: Takeda Pharmaceutical, Cherry Hill , Sr. Manager/Associate Director, Global Labeling (REMOTE), Executive , Cherry Hill, New Jersey
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