Regulatory Submissions Project Manager

Pharmica Consulting - New Haven, CT

The Project Manager must generally be steeped in the business of drug development with the ability to take on work from the client team and advance agreed upon deliverables with a high degree of independence.They must be comfortable working with teams and articulate both verbally and in written communications. MS Project is the key medium by which timelines are developed and any candidate must be perfectly comfortable with this tool. The PM needs to be able to help team members see and understand how their activities contribute to the overall plan.

  • Expertise in MS Project, Excel, Outlook, PowerPoint and general file management
    • High proficiency with Microsoft Project – timeline creation and modification, scenario planning, creation of timeline graphics w/One Pager Pro add-on
    • Technical proficiency with Project Web App (PWA) required
  • Expertise in Drug development – first-hand knowledge of activities associated with various stages of drug development
  • Ability to run/manage cross functional meetings with teams and individual team members to discuss activities, actions, timelines, and risks
  • Ability to work with teams to record meeting minutes and track action items
  • Ability to work with a team to update expense forecasts
  • Strong communication skills and ability to work with others
  • Minimum 10 years of experience in drug development/pharmaceutical industry

Submissions

  • Cross functional submissions team support
    • Deep experience and expertise in successful medicine regulatory submissions in the US (minimum) including the ability to create an MS Project timeline to support such submissions.
    • Ability to build a detailed submissions timeline with the team and organize document reviews that align with the timeline to accomplish filing deliverables


Posted On: Thursday, July 18, 2019



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