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.
- 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
- 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.