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Project Manager, Regulatory Science

Cambridge, Massachusetts 02142

Post Date: 02/28/2018 Job ID: 1788 Job Category: Clinical: Regulatory

My client is seeking a Project Manager, Regulatory Science. The purpose of this position is to provide project management for Regulatory Science for major marketing applications.  This position would serve as the lead project manager for these applications as well as additional submissions as assigned.   

  • Accountability for timeline development and management using MS Project and Project Server including execution of communication strategies to keep stakeholders aware and up to date on timelines and deliverables as well as cross-functional impacts of changes and decisions. 
  • Organizing and maintaining clear and timely team communications including: meeting agendas, minutes, decision logs, tasks lists, and risk analyses / mitigation strategies
  • Maintaining communications, timelines, and other project deliverables using preferred technologies such as Share Point, OneNote, and OneDrive
  • Identifying risks to project objectives, facilitation of mitigation and, if needed, escalating to Project Leadership in a timely manner
  • Organizing practice or “ mock” agency meeting sessions in preparation for Scientific Advice and pre-marketing application meetings. These responsibilities include working with Regulatory Science to prepare agendas, manage logistics, and organize location requirements


  • Accountability for Project Management of at least 1 major marketing application. Candidates who have participated on a major marketing application team in a leadership position will also be cosnidered.
  • A minimum of 7 – 10 years working for a company focused on the development of biotech and / or pharmaceutical products
  • A minimum of 5 years of project management experience.
  • Working knowledge of strategies and tools for ensuring clear and concise communication on cross-functional submission teams to ensure successful and timely project completion. 
  • Strong interpersonal and team skills
  • Strong verbal and written communication skills
  • Highly organized, proactive
  • Ability to analyze issues and develop solutions
  • Demonstrated ability to effectively manage multiple priorities and meet deadlines


Denise Kowalski
Clinical Recruiter

Denise is a focused, relationship-driven individual who brings creative energy and an eagerness to conquer new challenges to her role. A passionate life-long learner, Denise’s excellent communication skills, strong work ethic, and genuine interest in helping others make her a valuable asset to the Clinical team.

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