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Project Manager, Regulatory Operations - Oncology

Cambridge, MA

Posted: 03/15/2019 Job Category: Clinical: Regulatory Job Number: 2304

Our client is seeking an outstanding Project Manager to join their growing Regulatory Operations and Compliance team. This role will be responsible for project management activities related to assigned program including leading the end-to-end planning, coordination, and execution of major marketing applications in Europe and in the United States through approval as well as additional major submissions as assigned. This role will be accountable for timeline development/management, meeting facilitation, timely communications, driving deliverables, assessing and mitigating risks as well as organizing “ mock” Agency meeting sessions. These meetings will require cross-functional participation to prepare agendas, logistics, and location requirements.

  • Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment
  • MS Project and Project Server based timeline management: Coordinate input, maintenance and revision of the project plans for assigned projects, with escalation of unforeseen changes in resource demand, and project conflicts within a timely manner to Project Leadership
  • Experience leading multi-disciplinary, cross-functional project teams, working with all major contributing departments, including, but not limited to: Regulatory Science, Regulatory CMC, Medical Writing, Regulatory Operations, Preclinical, Pharmaceutical Sciences, etc. to ensure expectations are well understood and that timelines are intended to be met
  • Identify both regulatory and project risks, with potential solutions to cross-functional project team and leadership as needed
  • Organize and maintaining team communications including: meeting agendas, minutes, decision logs, tasks lists, and risk analyses / mitigation strategies using preferred technologies such as SharePoint, OneNote, and OneDrive
  • Provide coaching, and knowledge transfer to junior members of project management team

  • Project Management of the submission of at least 1 major marketing application. Client will consider applicants who have participated on a major marketing application team in a leadership position.
  • A minimum of 5 years working for a company focused on the development of biotech and / or pharmaceutical products
  • A minimum of 3 years of project management experience
  • Strong Microsoft Project skills
  • 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

Kathleen Hepburn, SPHR
Senior Recruiter

Kathleen has been providing Human Resources and Recruiting solutions to a wide range of organizations for over 20 years. Her areas of expertise include talent sourcing and acquisition, HR planning, employee relations, and performance management. She is credited with developing strategic partnerships to quickly identify and recruit talent; leading corporate initiatives to grow revenues and reduce expenditures; and creating effective programs to train, retain and reward employees.
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