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Global Regulatory Labeling Strategy Manager

Company: Takeda Pharmaceutical
Location: Bronx
Posted on: September 19, 2022

Job Description:

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 DescriptionAbout 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 Global Regulatory Labeling Strategy ManagerHow you will contribute:

  • You will work Operational support for preparation of CCDS for CCDS cross functional team review, transfers CCDS into latest CCDS template. Confirms 100% content transfer. Highlights to Global Labeling Lead (GLL) possible areas for functional team review.
  • Preparations of the USPI and SmPC Labeling Documents in alignment with the approved and updated language from CCDS.
  • Formatting and operational QC of updated CCDS, USPI and SmPC. Review of bookmarks, cross references and references in the labels. Checks correct formatting of mandatory CCSI, proofreading to check spelling, readability, typing errors and consistency with CCDS template.
  • Consistency check between CCDS and justification document, review documents to ensure changes in the CCDS are reflected accurately in the justification document.
  • Formatting and operational QC of CCDS post Global Labeling Oversight Committee (GLOC) endorsement, following any amendments made to CCDS during or post GLOC
  • Upload of CCDS and justification documents into eDMS. Coordinate with EU QPPV and Global Labeling Head or delegate, initiates workflows for CCDS and document approval in eDMS.
  • Preparation and finalization of event(s) in submission tracking system, Creation of Global Project Plan (GPP) in PRISM, creation of tracking ID in TRAIL, update of GPP and tracking ID after approval of CCDS in eDMS.
  • Provide support to Local Affiliates in Labeling activities, including but not limited to responses to health authorities requests, review of local labeling exceptions and coordinate global approvals; and review of local labeling alignment deferrals. -
  • Updating eDMS and submission tracking system with deferral requests and local exceptions, archival of deferral forms in Spectrum, and update PRISM event details (L-Takeda only). Archival of local exception forms in eDMS, update TRAIL with summary of approved exceptions.
  • Ad hoc activities, taking meeting minutes for labeling and cross functional team meetings, Doc Label reviews, labeling compliance activities, label comparison tables, GL Mailbox triage.
  • Liaises with US Labeling Operations and EU Labeling Operations to ensure labeling objectives and timelines are met.Minimum Requirements/Qualifications:
    • BS Degree in a science discipline. Advanced degree preferred.
    • Pharmaceutical industry experience preferred. -
    • 1-2 years of regulatory and/or related experience preferred -
    • 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 with individuals at all levels of the organization and comfortable presenting to small and large groups
    • Ability to prioritize while managing multiple projects of varied complexity and criticality and to adhere to timelines while demonstrating negotiation skills, integrity and adaptability.
    • Demonstrates problem-solving ability with ability to analyze risk, think strategically, and provide appropriate recommendations/decisions. -
    • Strong interpersonal skills combined with cultural sensitivity for successful global collaboration
    • Focus on accuracy and strong attention to detail is a must
    • Willingness to provide and receive constructive feedback
    • Self-motivated, self-starter with the ability to work independently and in a team with a flexible
    • MindsetWhat 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
      • Tuition reimbursementMore 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.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.EEO 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, New Rochelle , Global Regulatory Labeling Strategy Manager, Executive , Bronx, New York

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