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Sr. Manager/Associate Director, Global Labeling (REMOTE)

Company: Takeda Pharmaceutical
Location: North Bergen
Posted on: May 11, 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 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 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 asEDUCATION, 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% travelWHAT 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-KD1Absent 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 excludedPreference 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 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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, North Bergen , Sr. Manager/Associate Director, Global Labeling (REMOTE), Executive , North Bergen, New Jersey

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