Contract NDA Submission PM - With a Biotech company

  • inVentiv
  • Cambridge, MA, United States
  • Jun 15, 2017
Contractor Regulatory

Job Description

Order #: 102372

Title of Position: Contract NDA Submission Project Manager

Location: Cambridge, MA  

Zip Code: 02142

# of position openings:  1

Contract Length:   12mns

 

Job Description:

  • 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.