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 this role

The Generic Drug User Fee Amendments (GDUFA) were reauthorized for an additional five years beginning October 1, 2022. This reauthorization allows ORS to manage its workload effectively and provide predictability for industry. The number of projects managed within ORS has grown considerably, and making GDUFA III successful requires improved and newly created technical systems and processes.

The Project Manager II will help ORS manage its many projects through those systems and processes, providing project management support for ongoing regulatory and research-related tasks, including Pre-Abbreviated New Drug Application (Pre-ANDA) program activities. Much of ORS's work is tracked in the Research Management system and the Platform and Nexus system, which are used to manage pre-ANDA meetings, ANDAs, Controlled Correspondences, Clearances, and more. The Project Manager will oversee rollout, coordination, and communications across all aspects of this work, including research-related functions that support ongoing internal and external research.

RequirementsKey Responsibilities Manage and facilitate meetings in support of office development and implementation efforts.

Ensure timely resolution of scientific, regulatory, or IT issues to avoid delays in meeting GDUFA deadlines and goals.

Serve as point of contact and project manager for inquiries and requests submitted to the respective office.

Triage, assign, track, and archive OGD work projects (OGDP-specific).

Identify and document policies and processes related to generic drug development (OGDP-specific).

Oversee project timelines and ensure that documents are submitted on time.

Monitor progress of extramural and intramural research projects using databases, spreadsheets, and other internal systems.

Train scientific staff on how to use databases and other internal systems for research tracking.

Assist in tracking fiscal year data related to new and ongoing projects, as well as the initiation of new research.

Qualifications Based on the responsibilities above, strong candidates will bring:

Project management experience in a regulatory, scientific, or research environment, ideally with knowledge of FDA, generic drug development, or the GDUFA program.

Ability to manage multiple projects, timelines, and deliverables against firm regulatory deadlines.

Experience with project tracking databases, spreadsheets, and enterprise or workflow systems, and the ability to train others to use them.

Strong written and verbal communication skills, including facilitating meetings and serving as a point of contact for internal and external stakeholders.

Ability to document policies and processes clearly and to identify and resolve scientific, regulatory, or IT issues that could cause delays.

Familiarity with fiscal year tracking of project and research data.

Research Project, Grants & Contracts Support Perform updates on internal systems to reflect new data and information on research projects, and run reports using databases and internal systems with specific queries.

Monitor progress of research projects and oversee project timelines to ensure that documents are submitted/archived on time.

Coordinate updates of data related to research grants and contracts in the research database.

Coordinate the ORISE onboarding and offboarding processes; document and monitor the list of start and end dates.

Coordinate updates to the ORISE and Contracts SharePoint site page as a resource page for ORS research project leads.

Monitor and track Fiscal Year research contract statuses for the ORS research program, coordinate getting updates on statuses, and make updates in the databases accordingly.

Identify areas for modification in existing databases and communicate needs to the appropriate team members.

Train users by conducting regular walk-in clinics for users and staff of the SharePoint resources pages, supporting the ORISE processes and the research grants and contracts resources available to staff.

Education & Certification Bachelor's degree in life sciences, health sciences, business, project management, or a related field (master's degree preferred).

Project Management Professional (PMP) certification from the Project Management Institute (PMI) in good standing.

A minimum of five (5) years of project management experience, preferably in a federal, regulatory, scientific, or research setting.

Skills & Experience Candidates will bring:

Project management experience in a regulatory, scientific, or research environment, ideally with knowledge of FDA, generic drug development, or the GDUFA program.

Ability to manage multiple projects, timelines, and deliverables against firm regulatory deadlines.

Experience with project tracking databases, spreadsheets, and enterprise or workflow systems, and the ability to train others to use them.

Strong written and verbal communication skills, including facilitating meetings and serving as a point of contact for internal and external stakeholders.

Ability to document policies and processes clearly and to 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 with coordinating onboarding/offboarding processes (ORISE experience a plus).

BenefitsPPO/HMO Health Plan (includes medical, dental, and vision)

401K Retirement Plan

Paid Time Off (PTO)