Associate Director, Process and Training

Company: Takeda Pharmaceutical
Location: Silver Spring
Posted on: November 24, 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 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 DescriptionTakeda SQS is looking to add individuals to our team that are team oriented, collaborative, and who are exceptional leaders and innovators within the statistical programming space. - Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people and the planet.To attract and retain the very best talent, we in Takeda SQS are open to flexible or remote working for some roles. - Such roles will have a connection to a Takeda R&D center.ACCOUNTABILITIES

• Supports 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 - - -
• Develops and delivers training and education on SQS specific tasks and processes, technology platforms and statistical software in partnership with the Chief Statistical Office and others -
• Leads development and writing of programming processes and associated documentation - - -
• Develops expertise in all SQS processes to support and ensure inspection readiness and provides support for updating processes to address any identified gaps - -
• Interfaces 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 - -CORE ELEMENTS RELATED TO THIS ROLE
  • 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 - -
  • Demonstrated 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. -
  • Demonstrated initiative in staying abreast on current industry topics as they relate to functional area - - -DIMENSIONS AND ASPECTS - -Technical/Functional (Line) Expertise - -
    • 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 - -Leadership - -
      • Ability to partner with colleagues and leadership to understand process needs and gaps - -
      • Demonstrated ability to work and influence 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 -
      • Ability to distil complex technical ideas in simple comprehensible terms in order to influence decisions and outcomes -
      • Proactively implements sub-strategies to enable the promotion of SQS and DSI vision and mission within TAUs, BUs, and R&D functions - -
      • Leader both within and outside of Takeda in area of expertise for organizational initiatives. - - -Decision-making and Autonomy -
        • Decision making responsibilities: - -
          • Provide input to highly complex decisions that impact the statistical programming function -
          • Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions -
          • Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution - - -
            • Accountable for providing input to and implementing vision and strategy for designated scope - -Interaction
              • -Effectively navigates the changing external and internal environment and leads others through change by creating an inspiring and engaging workplace - -
              • Ability to effectively implement R&D's partnership strategy as it applies to statistical programming and statistics -
              • Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions, including but not limited to statistics, data management, information technology, clinical operations, regulatory, and the data sciences organization - - -
              • Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise. -
              • Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner -
              • Demonstrates flexibility in an ever evolving landscape - - -Innovation
                • Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation -
                • Challenge the status quo and propose forward thinking 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. -
                • Models respect and inclusion in all interactions, creating a culture that fosters innovation -EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS -
                  • -BA/BS in data science, statistics or a related field with minimum of 8 years of relevant experience in pharmaceutical industry. MA/MS/MBA a plus.. - -
                  • Demonstrated knowledge of clinical research with emphasis on statistics and statistical programming - -
                  • Intermediate level proficiency in SAS, R, Python or other programming language. -
                  • Understanding of CDISC standards and associated submission requirements -
                  • Experience in developing training materials -
                  • Experience with building, planning and executing training and educational courses -
                  • In-depth understanding of compliance risks facing the pharmaceutical industry with a particular focus on issues facing the clinical organization -
                  • Experience in problem solving, negotiations, and collaborative team building with non-direct reports and other stakeholders -
                  • Experience in writing technical documentation and standard operating procedures - -
                  • Experience in managing projects towards process improvements--- -
                  • Operational experience in pharmaceutical drug development with significant direct exposure to clinical development -
                  • Health care business acumen with a comprehensive understanding of the pharmaceutical industry - - -Empowering Our People to ShineDiscover more at takedajobs.comThis position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policyBase 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. - - -No Phone Calls or Recruiters Please. - EEO 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, Silver Spring , Associate Director, Process and Training, Executive , Silver Spring, Maryland