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Senior Manager, CMO Global Medical Evidence Systems and Operational Excellence - Remote

Company: Takeda Pharmaceutical
Location: Passaic
Posted on: January 10, 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 Takedas and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionSenior Manager, CMO Global Medical Evidence Systems and Operational Excellence, RemoteAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager, CMO Global Medical Evidence Systems and Operational Excellence in our Cambridge, MA - Virtual 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.As a Senior Manager, CMO Global Medical Evidence Systems and Operational Excellence working on the Global Medical Evidence team, you will be empowered to support the deployment and oversight of Global Medical Affairs (GMA) evidence generation related IT systems and processes. A typical day will include:POSITION OBJECTIVES:

  • Support the deployment and oversight of Global Medical Affairs (GMA) evidence generation related IT systems and processes
  • Ensure that GMA evidence generation related systems and processes are developed and implemented in accordance with all applicable internal procedural documents and regulatory laws and guidelines.
  • GMA evidence generation planning and excellence by development and implementation of appropriate tools, innovative approaches and collaborations with other business functions within the organization.
  • Oversee processes, systems and activities related to data curation and generation from a variety of internal and external sources to ensure data are centrally maintained, managed and available for various stakeholders to access seamlessly in real-time.
  • Support internal operational compliance activities to identify opportunities for continuous improvement in order to maximize audit and inspection readiness.POSITION ACCOUNTABILITIES:
    • Support the overarching vision and implementation plan for a center of excellence for pre- and post-registration medical evidence generation at Takeda.
    • Support the development and implementation of processes, systems and tools to enable efficient and compliant delivery, tracking, reporting and communication of Takeda Medical Affairs evidence generation activities.
    • Coordinate the capture, archiving and reporting of appropriate study level information (including patient safety-relevant information) and documentation
    • Conduct systemic data excellence reviews of study-level data collected in GME systems, escalate potential risks and provides proposals for improvements
    • Executes periodic GME-internal operational compliance checks to ensure GME systems and documentation comply with Takeda procedures
    • Coordinate information requests stemming from audits, Health Authority inspections and ad hoc requests in remit of GME, and provides responses on behalf of GME.
    • Partner with Business Solutions & Analytics to provide information in support of business metrics and KPIs.
    • May manage simple systems supporting key documentation review per medical evidence generation processes
    • Comprehensive understanding of the pharmaceutical industry and Medical Affairs
    • Advanced understanding of post-authorization medical evidence generation operations
    • Advanced experience in working with CTMS, iEnvisions, and documentation systemsEDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
      • BS or MS degree required
      • Degree in public health and/or epidemiology background preferred.
      • 5 years experience in pharmaceutical industry or healthcare management
      • Previous extensive experience in Medical Affairs evidence generation operations in more than one therapeutic areas of Takeda interests
      • Previous clinical operations experience, strongly preferred
      • Significant user experience with IT systems such as iEnvision, any CTMS and study documentation review systems
      • Expert knowledge of FDA and ICH regulations, and industry standards applicable to data capture and data management process
      • Ability to identify proactively and anticipate risk of non-compliance in a complex environment.Takeda U.S. Vaccine Requirement: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. 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.This job posting exclude Colorado applicants.TRAVEL REQUIREMENTS:
        • Ability to drive or fly to various internal and external meetings.
        • Required travel approximately (0 - 10%), including international trips, overnight stays, and some weekend commitments.WHAT 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 ProgramsEmpowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.*RM-LIEEO 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, Passaic , Senior Manager, CMO Global Medical Evidence Systems and Operational Excellence - Remote, Healthcare , Passaic, New Jersey

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