Knowledge amplification

1. Accelerate learning

  • Engage team members in designing the submission plan and processes
  • Ensure everyone knows the details and tools, is trained and ready
  • Insert learning cycle while optimizing and de-risking the submission plan

2. Identify, gather and log data

  • Assess organizational submission readiness
  • Perform lessons learned throughout the project
  • Transfer knowledge within and across teams

3. Introduce best practices

  • Define document review, QC and publishing processes
  • Implement tools to be used
  • Freeze the timeline and manage execution: tick the boxes

Efficiency engineering

4. Reflect and co-create executional plans

  • Organize co-creation workshops
  • Ensure everyone is on the same page and understands their part of the puzzle. Involve admins, vendors, CROs, CMOs, … early on.
  • Translate standard timelines and approaches to project specific ones with the people doing the work

5. Optimize process and mitigate risks

  • Rehearse: hold pilots, do dry-runs, write and review shell documents
  • Drill down to the detail for critical path items and hand-offs
  • Turn assumptions into agreed upon steps
  • Identify risks and develop mitigations pro-actively

6. Insert scenario planning and time management

  • Avoid continuously changing the plan
  • Contain creativity (unless data dictate otherwise)
  • Turn the plan into a roadmap, create visibility, and tick the boxes

Resource optimization

7. Assess and ensure organizational readiness

  • Assess submission readiness, identify strengths and gaps
  • Create focus on submission effort
  • Ensure both team members and doers know the details

8. Perform gap analysis and adjust resources

  • Check if critical resources are available for all areas to make it happen: can we deliver?
  • Be creative within the resource constraints

9. Assign pragmatic roles and responsibilities

  • Know exactly who will do what, when and how
  • Introduce concept of document owner & lead writer for key submission documents
  • Ensure smooth hand-offs, including with and between vendors, CMOs, CROs

Embedded coaching

10. Assess company culture and insert people management skills

  • Assess organizational culture in relation to submission readiness
  • Facilitate change management aspects
  • Provide feedback and act as sounding board

11. Enhance team spirit and safeguard interconnectivity

  • Communicate, communicate, communicate
  • Bridge between and across functions
  • Celebrate project milestones

12. Ensure individual accountability

  • Ensure clear roles and responsibilities to assign accountability
  • Monitor execution, incl. oversight of vendors
  • Create clarity around the role and involvement of senior management
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