Manager - Change Management - Global Regulatory Affairs

Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: January 21, 2023

Job Description:

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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.
How you will contribute:

• Reporting to the Director of Organizational Change Management, this position will assist in leading technical writing and instruction design efforts while utilizing OCM practices (project management, Stakeholder management, communication strategies, and implementation). They will lead in creating & designing plans for learning, training, and communication details.
• This role will assist in further developing our change management strategy to create and execute the change management plans and related deliverables throughout the program's deployment journey, from Design to Stabilize
• This role will partner closely with colleagues throughout the R&D organization, starting with Global Regulatory Operations, under Global Regulatory Affairs. This will include (but not be limited to) Regulatory Information management (RIM), Clinical Operations, PMO, Compliance, Quality, Program/Project Teams
• Partners with the GRA OCM team and subject matter experts to develop adoption content to enable end users to execute new processes and shift towards new cultural models.
• Executes & and develops communication content in collaboration with the Senior Communications & Engagement Change Manager to create
• Active participant in the Process Optimization Change Management Workstream, working as an optimization advocate
• Supports operational excellence & project optimization success by balancing change management activities and communication planning with appropriate communication tools
• Assists in the development and oversees stakeholder relationships related to optimization initiatives
• Fosters a sense of teamwork in all parts of the organization to actively participate in process improvement and optimization ACCOUNTABLITIES
  • Abel to work in large cross-functional teams to design, develop, and execute change management efforts from a content development perspective
  • Writing, editing, and proofreading materials for reports, briefs, proposals, instructional material, and software and hardware documentation provided by technical personnel.
  • Obtaining data from a review of documentation, interviews with client and project personnel (SMEs), drawings, schematics, reports, and the study of published material.
  • Researching and gathering technical and background information for inclusion in project documentation and deliverables.
  • Developing outlines and drafts for review and approval by technical specialists and stakeholders ensuring that final documents meet applicable contract requirements and regulations.
  • Demonstration of strong writing and editing skills through provided writing samples
  • Demonstration of advanced PowerPoint graphics skills
  • Demonstration of strong organizational and analytical skills
  • Demonstrated strong capabilities with Instructional design and graphic design tools such as (but not limited to Articulate, Adobe Captivate, Brainshark, Vyond, Canva and etc.
  • Must be a team player who is self-motivated and takes initiative
  • Able to lead and manage vendors' design and development of content for large projects.
  • Assist in the definition of workstream scope and objectives with regards change and communication, involving all relevant stakeholders and ensuring relevant and timely engagement
  • Translate business needs into operational excellence communications, creates an optimized awareness of 'this mean that' to intended audience / community
  • Collaborate in developing detailed communication plans, with appropriate metrics for monitoring effectiveness
  • Participate in curating and implementing innovative ways to communicate to stakeholders to improve visibility of team and associated initiatives CORE ELEMENTS RELATED TO THIS ROLE
    • Explicit knowledge and experience in utilizing technical writing and instructional design to develop global learning and communication content. DIMENSIONS AND ASPECTS
      
      Technical/Functional (Line) Expertise
      • Demonstrate excellent planning, time management and scheduling skills for self and others contributing to the communication elements of the optimization element of that roadmap
      • Credible engagement with cross functional stakeholders with regards the various optimization initiatives
      • Understanding and proven experience in Learning and Development Leadership
        • Influence others at all levels & work collaboratively across different stakeholders
        • Strong ability to recognise and consider interdependencies of change and communications planning in a fast paced and dynamically complex business, translate to engagement solutions, communicate same at all levels
        • Work collaboratively in a cross-functional team environment, across multiple time zones Decision-making and Autonomy
          • Take initiative and coordinate resources to drive tasks to deadlines
          • Demonstrate innovative solutioning skills, working with the Optimization Team/s and other identified parties, to drive proposals to anticipate and meet demand, influence decion making to feasible solutions and appropriate communications
          • Use collaboration skills and partnerships to work within agreed Governance Model Interaction
            • Confidently engage with external vendors and manage internal stakeholders, representing the needs of the business and those of Optimization team/s and our internal partners
            • Express self clearly and concisely at all levels, in both verbal and written communication
            • Demonstrate maturity of critical thinking
            • Embrace diversity, adapt to other personalities in a respectful manner that is conducive to goal achievement
            • Create and deliver clear and professional presentations with appropriate messaging and focused recommendations. Innovation
              • Establish appropriate tools with which to emphasize our overall vision with the relevant stakeholders, working with Vendors and developers to ensure optimization initiatives are fully aligned to GRA transformation roadmap
              • Identify and gain agreement for innovative analysis, reporting, and monitoring tools to assist LT/steer co's in their strive to understand hot topics within the business, providing insights from the results where appropriate.
              • Ability to develop SharePoint sites and related tools to promote engagement with initiatives Complexity
                • Understand the changing needs and priorities of the business, specifically in relation to GRA
                • Understand complex issues with Transformation and to propose timely, cost-effective and achievable solutions in relation to comms and change, mindful of flexibility rather than a 'one size fits all' approach
                • Work in a fast paced environment with demonstrated ability to delegate & juggle multiple competing tasks and demands, often with a degree of ambiguity EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
                  
                  Required:
                  • BS or MA degree in instructional design, educational technology or similar
                  • A minimum of 2+ years editing experience
                  • 2+ years of experience in Microsoft Office Suite and expert-level in PowerPoint
                  • 1+ years of experience preparing documentation and developing graphics for delivery or publication
                  • 1+ years supporting Information Technology projects required
                  • Proficiency in creating representative graphics for systems architecture diagrams
                  • Experience writing system design documents including functional descriptions and system specifications
                  • Excellent writing and editing skills
                  • Proven working experience in instructional design and with instructional technology
                  • Excellent knowledge of learning theories and instructional design models
                  • Lesson and curriculum planning skills
                  • Basic HTML and Flash programming knowledge
                  • Solid knowledge of course development software and at least one Learning Management System
                  • Visual design skills (Dreamweaver, Photoshop, Illustrator) and ability to storyboard
                  • Ability to write effective copy, instructional text, audio scripts/video scripts Desired:
                    • Considerable knowledge of change management & dealing with complex and dynamic business environments, including integration projects
                      • Good working knowledge of Global Regulatory Affairs and overall R&D functions
                      • Awareness/understanding of regulatory processes, operations and standards in pharmaceutical development
                      • Experience of working within an AGILE Framework is a plus ADDITIONAL INFORMATION
                        • International travel may be required (Up to 20%)
                        • Ability to attend offsite meetings that may involve an overnight stay This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
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Keywords: Takeda Pharmaceutical, Cherry Hill , Manager - Change Management - Global Regulatory Affairs, Executive , Cherry Hill, New Jersey