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Associate Director, Process and Training

Company: Takeda Pharmaceutical
Location: Clifton
Posted on: January 25, 2023

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 Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as an Associate Director, Process and Training where you will support execution of strategic plan related to training for all SQS Programming staff and partnered vendors to meet the needs of the business and ensure GcP compliance and lead development and writing of programming processes and associated documentation. As part of the Programming team, you will report to the Director or Senior Director, Programming and Build strong relationships and collaborate effectively with other interfacing Takeda functions, including but not limited to statistics, data management, clinical operations, medical directors.

How you will contribute:

  • Develop and deliver training and education on SQS specific tasks and processes, technology platforms and statistical software in partnership with the Chief Statistical Office and others
  • Develop expertise in all SQS processes to support and ensure inspection readiness and provides support for updating processes to address any identified gaps
  • Interface with cross-functional subject matter experts and quality organization in preparation for audit and inspection planning, implementation and follow-up
  • Successfully engages cross-functionally to progress tasks with proven influencing skills
  • Leads process improvement initiatives to successful completion
  • Solid project management, leadership and problem-solving skills with the ability to execute on plans with limited direction and support
  • Proven conceptual thinking and strategic problem-solving ability
  • Ability to prioritize and lead cross-functionally to achieve goals
  • Ability to write detailed procedure and policy documents based upon discussions with process owners and in compliance with technical writing standards and to provide mentoring in this area for others in the organization
  • Proven ability to distill technical jargon and communicate effectively
  • Demonstrate flexibility to adjust to a broad range of responsibilities
  • Solid knowledge and experiences with GCP regulatory inspections
  • Proven ability to adapt to change and manage cultural change in an evolving environment.
  • Demonstrate initiative in staying abreast on current industry topics as they relate to functional area
  • Possess a comprehensive understanding of the pharmaceutical industry and statistical programming ecosystem (e.g., clinical development, the prescription drug distribution process, etc.)
  • Possess technical expertise at the enterprise level and specifically related to technical writing standards
  • Capable of leading cross-functional teams addressing a wide variety of the organization's needs
  • Demonstrate expertise in industry trends and regulatory policy initiatives including GcP, CRF 21 Part 11 compliance, and other ICH guidelines Minimum Requirements/Qualifications:
    • BS in computer science, statistics, data science or related field with 10+ years of industry related experience.
    • In-depth knowledge of statistical programming software (e.g. SAS, R, Python) and common technology platforms
    • Intermediate level proficiency in SAS, R, Python or other programming language.
    • Proven track record leading end user support for a technical organization
    • Experience developing and delivering user training for statistical systems
    • Experience with version control applications
    • Experience working on AWS and other cloud computing platforms
    • Experienced in SDLC methodologies, software validation, SOP authorship, and technical documentation.
    • Experienced in managing projects towards process improvements
    • Operational experience in pharmaceutical drug development with significant direct exposure to clinical development What Takeda can offer you:
      • Comprehensive Healthcare: Medical, Dental, and Vision
      • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
      • 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 and company match of charitable contributions
      • Family Planning Support
      • Flexible Work Paths
      • Tuition reimbursement More about us:

        At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

        This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

        Base Salary Range: $137,200 $196,000 based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off

        The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
        • In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. Empowering our people to shine:

          Takeda 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.

          EEO Statement

          Takeda 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.

          Locations

          Boston, MA

          Worker Type

          Employee
          Worker Sub-Type

          Regular
          Time Type

          Full time

Keywords: Takeda Pharmaceutical, Clifton , Associate Director, Process and Training, Executive , Clifton, New Jersey

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