Takeda Pharmaceuticals Global Labeling Senior Manager in Montgomery, Alabama
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 an Sr Manager., Global Labeling (Remote)
How you will contribute:
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 required.
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.
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.
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
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 "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
Base Salary Range: $124,600 to $178,000, 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.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
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.
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