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
