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

Company: Takeda Pharmaceutical
Location: Mount Vernon
Posted on: November 12, 2021

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 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 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
    • 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 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 labeling strategies.
    • 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 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.
      • 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 trips.
        • 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 Information:
          • 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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