Project Manager II - Research Management, Expert and Scientific Support Services for Generic Drug Program in support of Office of Generic Drug User Fee Amendments (GDUFA)
About The Position
The Project Manager II will support the Office of Regulatory Science (ORS) in managing projects for the Generic Drug User Fee Amendments (GDUFA) program. The role provides project management support for ongoing regulatory and research-related work, including Pre-Abbreviated New Drug Application (Pre-ANDA) program activities. Work is tracked in systems such as Research Management and Platform and Nexus, which support pre-ANDA meetings, ANDAs, Controlled Correspondences, Clearances, and other activities. The Project Manager will oversee rollout, coordination, and communications across this work, including research-related functions supporting internal and external research. The position also supports research projects, grants, and contracts by maintaining research data in internal systems, monitoring project timelines and fiscal-year contract statuses, coordinating database and SharePoint updates, and training staff in relevant systems and processes.
Requirements
- Bachelor's degree in life sciences, health sciences, business, project management, or a related field.
- Project Management Professional (PMP) certification from the Project Management Institute (PMI), in good standing.
- At least five years of project management experience, preferably in a federal, regulatory, scientific, or research setting.
- Project management experience in a regulatory, scientific, or research environment.
- Ability to manage multiple projects, timelines, and deliverables against firm regulatory deadlines.
- Experience with project tracking databases, spreadsheets, and enterprise or workflow systems, and ability to train others to use them.
- Strong written and verbal communication skills, including meeting facilitation and service as a point of contact for internal and external stakeholders.
- Ability to document policies and processes clearly and identify and resolve scientific, regulatory, or IT issues that could cause delays.
- Familiarity with fiscal-year tracking of project and research data, including research grants and contracts.
- Experience with SharePoint resource pages and coordinating onboarding and offboarding processes.
Nice To Haves
- Master's degree preferred.
- Knowledge of FDA, generic drug development, or the GDUFA program.
- ORISE experience.
Responsibilities
- Manage and facilitate meetings supporting office development and implementation efforts.
- Resolve scientific, regulatory, or IT issues in a timely manner to help meet GDUFA deadlines and goals.
- Serve as the point of contact and project manager for inquiries and requests submitted to the respective office.
- Triage, assign, track, and archive OGD work projects.
- Identify and document policies and processes related to generic drug development.
- Oversee project timelines and ensure documents are submitted and archived on time.
- Monitor progress of extramural and intramural research projects using databases, spreadsheets, and other internal systems.
- Train scientific staff and other users to use databases, internal systems, and SharePoint resource pages for research tracking and related processes.
- Assist in tracking fiscal-year data for new and ongoing projects and research initiation.
- Update internal systems with research project data and information, and run reports using specific database and system queries.
- Coordinate updates to research grants and contracts data in the research database.
- Coordinate ORISE onboarding and offboarding processes and document and monitor start and end dates.
- Coordinate updates to the ORISE and Contracts SharePoint site page for ORS research project leads.
- Monitor and track fiscal-year research contract statuses, coordinate status updates, and update databases accordingly.
- Identify database modifications and communicate needs to appropriate team members.
- Conduct regular walk-in clinics for users and staff on SharePoint resources, ORISE processes, and research grants and contracts resources.
Benefits
- PPO/HMO health plan including medical, dental, and vision coverage.
- 401K retirement plan.
- Paid time off (PTO).
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
