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Senior Manager, GRA, Labeling Compliance

Company: Takeda Pharmaceutical
Location: Lambertville
Posted on: May 14, 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, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager, GRA, Labeling Compliance in our Kendall Square, MA office.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Here, you will be a vital contributor to our inspiring, bold mission.POSITION OBJECTIVES:

  • Manage deferrals, exceptions, and basis label communication and triage working closely with LOC RAPs, Global Labeling, and other members of the Global Labeling Compliance team.
  • Partner with internal stakeholders and external CRO partners such as Global Regulatory Compliance, Global Labeling, IT, Global Regulatory Operations, GPSE, Regulatory Therapeutic Areas, Local Operating Companies and Supply Chain for successful day-to-day activities of labeling compliance.
  • CAPAs/QEPOSITION ACCOUNTABILITIES:
    • With Global Labeling Compliance leadership, provides Global Labeling Compliance support for internal and external audits:
      • Ensure inspection readiness
      • Coordinates Global labeling documentation requests prior to, during and in follow up to inspections/audits
      • Supports the development of responses and CAPAs related global labeling for audits/inspections
      • Escalate issues/problems to management as needed
      • Maintains strong knowledge of current regulations, legislation, best practices and guidelines relating to Regulatory Affairs and labeling.
      • Represents Labeling Compliance on strategic initiatives impacting labeling event management systems and labeling compliance activities.
      • Supports work on business partner agreements related to labeling activitiesCORE ELEMENTS RELATED TO THIS ROLE
        • Strong knowledge of the regulatory labeling requirements on major markets like EU, USA, Canada, U.K. and other international markets.
        • This role is global and has cross-functional collaboration across multiple parts of the Regulatory, Regulatory Compliance, Quality and R&D groups including TAU, MPG, Global Labeling, Labeling Operations and CROs.
        • Quality System, Regulatory drug development experience, submission planning, regulatory project management and IT technical saviness is key for this role to be successful.
        • Systems Knowledge -knowledge of Quality Management Systems, including Deviation (Trackwise) systems.Technical/Functional (Line) Expertise
          • Comprehensive understanding of the pharmaceutical industry and the labeling regulatory requirements.
          • Comprehensive understanding of the Regulatory Compliance function. Leadership -
            • Demonstrated ability to work across functions, regions and cultures
            • Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
            • Proven skills as an effective team player who can engender credibility and confidence within and outside the company
            • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
            • Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives.
            • Invests time in helping others to enhance their skills and perform at a higher levelDecision-making and Autonomy
              • Provide input to highly complex decisions that impact the functional area
                • Accountable for providing input to and implementing vision and strategy for designated scopeInteraction
                  • Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
                  • Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
                  • Ability to build strong relationships and collaborate effectively with other interfacing Takeda functionsInnovation
                    • Comfortable challenging the status quo and bringing forward innovative solutions
                    • Ability to take risks implementing innovative solutions, accelerating time to market
                    • Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.Complexity
                      • Ability to work in a global ecosystem (internal and external) with a high degree of complexity EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: -
                        • Bachelor's degree (or equivalent) required. Masters preferred.
                        • 6 plus years' experience in Pharmaceutical industry, with exposure to Regulatory Affairs, labeling, and/or quality assurance/compliance (or equivalent).
                        • Familiarity with inspections and audit procedures
                        • Ability to identify risk of non-compliance in a complex environment
                        • Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment. -
                        • Able to manage both time and priority constraints and to manage multiple priorities simultaneouslyWHAT 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 ProgramsEffective 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.Empowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.This job posting excludes CO applicants.#LI-SGMEEO 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.LocationsCambridge, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Trenton , Senior Manager, GRA, Labeling Compliance, Executive , Lambertville, New Jersey

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