Sr. Manager/Associate Director, Global Labeling (REMOTE)
Company: Takeda Pharmaceutical
Location: New Brunswick
Posted on: May 12, 2022
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Job Description:
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to the best of my knowledge.
Job Description
Are 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 OBJECTIVES:
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 requirements.
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.
POSITION ACCOUNTABILITIES:
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
Lead
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 team.
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
EDUCATION, 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 strategies.
TRAVEL REQUIREMENTS:
Willingness to travel to various meetings, including overnight
trips.
Requires approximately up to 10-30% travel
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution
Plan
Tuition reimbursement
Company match of charitable contributions
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
#LI-KD1
Absent 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 Information:
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
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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.
In accordance with the CO Equal Pay Act, -Colorado Applicants Are
Not Permitted to Apply.
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
Full time
Keywords: Takeda Pharmaceutical, New Brunswick , Sr. Manager/Associate Director, Global Labeling (REMOTE), Executive , New Brunswick, New Jersey
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