Order #: 102372
Title of Position: Contract NDA Submission Project Manager
Location: Cambridge, MA
Zip Code: 02142
# of position openings: 1
Contract Length: 12mns
- Provide support to ensure the Regulatory Lead and cross functional program team develop and seamlessly execute global regulatory strategies enabling successful marketing applications with Health Authorities.
- Utilize robust project management methodologies to ensure the development, utilization and continuous improvement of tools and processes to meet project deliverables.
- Ensure product specific strategies are documented, maintained, updated and proactively coordinated and endorsed by key stakeholders. Ensure transparent and constant communication of objectives and strategies across program teams, sub-teams, and senior stakeholders.
- Encourage and model creative problem solving and demonstrate innovative approaches in working within a dynamic environment. Assist regulatory lead in problem solving and generate options to enable effective and timely decision making.
- Develop and maintain project plan and ensure execution of regulatory filing focused on quality and schedule.
- Prepare and coordinate meetings including scheduling agendas, minutes, action item and decision logs and timelines. Maintain real-time project documentation to ensure alignment and agreement on tasks, timing and approach.