REGULATORY PROJECT MANAGER, ONCOLOGY (CONTRACTOR) at Atreca
Redwood City, CA, US

We are seeking an outstanding contract regulatory project manager with biopharma experience who will apply project management methodologies to facilitate and manage major regulatory filings and related projects.  

Responsibilities

  • Accountable for planning and coordination of all activities related to regulatory filings, Pre-IND/IND/BLAs. The candidate will work with a variety of functions to construct and drive timelines.
  • Responsible for creating detailed project plans which identify and sequence the activities and dependencies needed to successfully meet target timelines.
  • Ensure regular and meaningful project communications, including dashboards, reports and metrics, to enable timely information and analyses to key stakeholders and decision makers.
  • Proactively track and manage project tasks against deadlines.
  • Monitor the progress of the project, identify necessary adjustments, and communicate to ensure the successful completion of the project
  • Facilitate timeline risk assessment and align with key stakeholders. Develop, execute and report on risk mitigation or issue resolution activities.
  • Collaborate with Managers from cross-functional teams as necessary 
  • Function as a meeting facilitator between various teams and resolve conflicts as they arise using collaborative management skills

Qualifications:  

  • Successful candidate must have a minimum of 3 yrs of project management experience in regulatory environment in pharmaceutical/biotech industry.
  • Bachelor’s Degree in a relevant/scientific discipline required.
  • Project management certification (i.e. PMP from PMI) is preferred.
  • Strong communication and presentation skills.
  • Strong experience in facilitating project team meetings, cross-functional communication and decision making
  • Proven leadership skills, maturity and emotional intelligence.
  • Proficiency with MS project required.
  • Experience with SharePoint required.
Atreca is an equal opportunity employer.