Global Project Management

How do I make sure my NDA submission happens on time when my company has never done one before?

How do I get the best chance of a positive outcome in my meeting with FDA and EMA?

How do I make sure I haven’t missed anything in my development plan?

How do I monitor and mitigate the risks to my program? When should my mitigation strategy kick in?

How do I make sure I actually reach my objective for my project?

What is change management and why should I care about it?

How do I keep my budget under control?

How do I make sure everyone in the team is doing things the same way?

I don’t understand Gantt charts—they look complicated. Why do I have to have one?

Example of solutions to address the above questions

  • Lead project teams to ensure business objectives are met and expected benefits are realized
  • Provide a structured approach to operations to manage critical inter dependencies
  • Develop budgets and project plans for development activities
  • Facilitate and document process and procedure development
  • Assess and monitor risk and risk mitigation strategies
  • Prepare materials and facilitate meeting preparation for interactions with regulatory authorities
  • Lead change management initiatives
  • Define, prioritize, understand, and measure the impact of projects on an organization to manage a portfolio