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Senior Manager, GRA, Global Compliance

Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: May 7, 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 DescriptionOBJECTIVES/PURPOSE

  • Working with GRA Compliance leadership and key stakeholders, manage the program for the tracking, implementation, execution, and reporting of GRA processes and responsibilities that drive excellence in pre and post submission activities.
  • Partners with internal stakeholders and external CRO partners such as Global Regulatory Compliance, IT, Global Regulatory Operations, Labeling, GPSE, Regulatory Therapeutic Areas, and Local Operating Companies for successful Regulatory Affairs compliance management of clinical trials.
  • Support process change management, communication/training, completion of CAPAs/QEs, and audit and Inspection support of GRA responsibilities.ACCOUNTABILITIES
    • With Global Compliance leadership, provides Global Compliance support for inspections and audits:
      • Ensure inspection readiness
      • Coordinates documentation requests prior to, during and in follow up to inspections and audits on behalf of Regulatory Affairs
      • Supports the development of responses and CAPAs related to Regulatory Affairs 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.
      • Represents GRA Compliance on strategic initiatives impacting Regulatory Affairs systems and processes.
      • Supports work on business partner agreements related to labeling activitiesCORE ELEMENTS RELATED TO THIS ROLE
        • Strong knowledge of the regulatory requirements in major markets like EU, USA, Canada, U.K. and other international markets.
        • This role is global and has cross-functional colaboration across multiple parts of the Regulatory, Regulatory Compliance, Quality and R&D groups including TAU, MPG, Global Labeling, Labeling Operations and CROs.
        • Quality System Management and Regulatory drug development experience is key for this role to be successful.
        • Systems Knowledge -knowledge of Quality Management Systems, including Deviation (Trackwise) systems, SharePoint, and Regulatory Information Management (RIM).DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise
          • Comprehensive understanding of the pharmaceutical industry and the labeling regulatory requirements.
          • Comprehensive understanding of the Regulatory Compliance function. Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
            • 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
            • Invests time in helping others to enhance their skills and perform at a higher levelDecision-making and Autonomy
              • Decision making responsibilities:
              • 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 simultaneouslyEEO 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, Cherry Hill , Senior Manager, GRA, Global Compliance, Executive , Cherry Hill, New Jersey

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