Manager, Global Labeling Associate
Bio-Life Plasma, LLC
Boston, MA
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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 Manager, Global Labeling Associate where you will be responsible for the formatting and operational support to Global Labeling Leads for CCDS. You will also provide operational support to Global Labeling Leads for USPI and EU SmPC.
How you will contribute:
With appropriate supervision and guidance:
Labeling Cross-Functional Teams
Responsible for ad-hoc activities such as scheduling meetings, preparing presentation slides, taking meeting minutes, labeling compliance activities, label comparison tables, and GL Mailbox triage.
Senior Management Cross-Functional Team (GLOC)
Responsible for consistency check between CCDS and other documents (i.e., GLOC slides).
Provides support to Global Labeling Leads in the preparation for and coordination of Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC) reviews.
Labeling Documents Authoring
Responsible for the formatting and operational QC of updated CCDS (i.e., review bookmarks and cross references, spelling checks, readability, consistency with template).
Uploads CCDS and other relevant documents into eDMS.
Initiates workflows for CCDS and document approval in eDMS.
Responsible for the preparation and finalization of event(s) in labeling event tracking systems.
Responsible for the distribution of new/revised CCDS and other relevant documents to impacted stakeholders.
Provides support to Global Labeling Leads in the coordination of cross-functional reviews and approvals.
Local Exceptions and LOC Interactions
Provides support to Global Labeling Leads in the processing of Local Affiliates questions and requests such as local health authorities requests, review of local labeling exceptions and alignment deferrals.
Updates labeling event tracking system with deferral requests and local exceptions TRAIL with summary of approved exceptions.
Escalation Process and Stakeholder Management
Appropriately escalates issues to their direct line manager.
Working within Labeling Team and GRA
Liaises with Global Labeling Leads, US Labeling Operations and EU Labeling Operations to ensure labeling objectives and timelines are met.
Minimum Requirements/Qualifications:
BSc degree, preferred; BA accepted.
2+ years of pharmaceutical industry experience preferred or 1+ years of regulatory and/or related experience preferred.
Willingness to provide and receive constructive feedback.
Demonstrates acceptable oral and written communications.
Begins to demonstrate acceptable problem-solving ability.
Basic familiarity with global standards and regulations related to CCDS and Product Labeling (At minimum, US PI and/or EU SmPC. Other regional labels also preferred).
Basic familiarity with labeling role in regulatory teams.
Ability to complete projects and to assist in the delivery of accurate and complete work while adhering to designated timelines.
Strong interpersonal skills combined with cultural sensitivity for successful global collaboration.
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.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MAU.S. Base Salary Range:
$108,500.00 - $170,500.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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.