Regulatory Project Management, Sr. Manager or Associate Director

My client is a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic and rare diseases.  They are seeking an Associate Director or Sr. Manager of Regulatory Project Management to serve as the lead project manager for upcoming major marketing applications.  You will work closely with Regulatory Affairs and Regulatory Submissions to ensure that deliverables meet the required timelines and identify any key risks.  Now is an exciting time to join the gene therapy revolution!

Responsibilities:

  • Timeline development and project 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.
  • Working with Regulatory Science team to prepare agendas, manage logistics, and organize location requirements.

Knowledge and Skills:

  • Bachelor degree in a scientific discipline.
  • A minimum of seven years industry experience working on the development of biotech and/or pharmaceutical products with at least five years of regulatory project management experience.
  • Previous project management of at least one major marketing application (NDA, BLA or MAA).
  • 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 experience with MS Project and Project Server. Experience with Share Point, OneNote, and OneDrive preferred.
  • 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.

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