Sr. Manager/Associate Director, Global Labeling (Associate Director is REMOTE)
Company: Takeda Pharmaceutical
Location: Mount Vernon
Posted on: November 12, 2021
By clicking the -Apply- button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's and . I further attest 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
Sr. Manager/Associate Director, Global Labeling. The Sr. Manager
position is based in Cambridge, MA and the Associate Director
position is remote.Here, everyone matters and you will be a vital
contributor to our inspiring, bold mission. As Sr.
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
- 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
- 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
- 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 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
- Analyzes relevant competitor labeling to ensure Takeda products
have the most competitive labeling possible; maintain awareness of
recent in-class approvals.
- 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.
- Prepares/leads training and information sessions with GRA and
other functional areas to increase understanding and compliance
with internal and external labeling expectations and optimal
- Establishes and manages cross-functional relationships to
ensure control and continuous improvement of global labeling
programs to meet business needs and regulatory
requirements.EDUCATION, EXPERIENCE AND SKILLS:
- BSc Degree, preferred. BA accepted. Advanced scientific degree
(MSc, PhD, or PharmD) preferred;
- 8+ years of pharmaceutical industry experience. This is
inclusive of 6 years of labeling experience or combination of 5+
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
- 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
- Responsible for demonstrating Takeda leadership behaviors.
- Must be available to work during the working hours of the time
zone in which the position is based.TRAVEL REQUIREMENTS:
- Willingness to travel to various meetings, including overnight
- Requires approximately up to 10-30% travelEffective November 1,
2021, 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. As of the same date,
absent an approved religious or medical reason, US field-based
employees, employees must be fully vaccinated in order to continue
in their current roles.- 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. Candidates are
encouraged to speak with their recruiter to seek further
information on the applicable guidelines for the Business
Unit/Function for which they have applied.Location and Salary
- Post Role Location(s)
- 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?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.LocationsBoston, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Mount Vernon , Sr. Manager/Associate Director, Global Labeling (Associate Director is REMOTE), Executive , Mount Vernon, New York
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