Regulatory Project Manager

Location: Boston, MA

Seeking a project manager to manage the work of a regulatory submission unit at a statistical and data management center providing statistical analysis and support for clinical trials.

Project Manager Duties:

  • Schedule team meetings, establish meeting agendas, coordinate meeting logistics, distribute pre-read meeting materials ahead of time, and publish meeting minutes in a timely manner.
  • Maintain project schedule by working with team members. Hold cross-functional team members accountable for the deliverables. Ensure the deliverables are completed on time.
  • Maintain a central repository for study deliverables, other documents such as project plans, meeting minutes, etc.
  • Facilitate team meeting and drive productive discussions according to the agenda.
  • Create ongoing project status updates for internal/external stakeholders (i.e. senior management, steering committee, etc.)

Additional Responsibilities (but may not be limited to):

  • Work with Regulatory Director to ensure alignment with project objectives and timelines.
  • Partner closely with project lead(s) to ensure alignment with project objectives and timelines.
  • Create and review content to ensure the information contained aligns with the intended purpose.
  • Apply project management expertise including planning, tracking and facilitating meetings and documenting decisions, risks and actions.
  • Act as catalyst and primary contact for work and team assignments.
  • Provide timely information for reporting.
  • Independently manage priorities and assignments.
  • Ensure team dynamics are collaborative.

Qualifications:

  • 2-4 years+ experience of relevant work settings, with biotech or the pharmaceutical industry settings a plus.
  • Excellent oral and written communication skills.
  • Excellent organizational skills.
  • Experience in regulatory a plus.
  • Must work well in a collaborative team environment and communicate effectively with all levels of the individuals in the organization.
  • Minimum Bachelor's degree in business or health related field; project management certification a plus.

Send resume/cover letter to jobs-ma@frontierscience.org

If you are unable to use email, you may mail a resume & cover letter to the address below:
Frontier Science Foundation
Attn: HR
1371 Beacon Street, Suite #203
Brookline, MA 02446

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, or veteran status.