SAIC is seeking a Project Manager to support the research program of the FDA’s
Center for Biologics Evaluation and Research, OTAT office. SAIC supports the FDA and their
scientists in Scientific Computing which includes but is not limited to;
technical and research aspects (e.g., hardware, software, desktop support,
infrastructure, virtualization all in a laboratory environment) supporting a variety
of FDA Centers. This position will support the Office of Tissue and Advanced
Therapies, Division of Regulatory Project Management to assist this Division
achieving its scientific and programmatic objectives.
Primary Duties and Responsibilities include, but not limited to:
schedule and coordinate key stakeholder meetings and the conferences
prepare submitted meeting packages and distribute to the review team
the review of received packages and disposition appropriately to the
correct data storage location.
meeting attendees and navigate proper clearance via FDA Security Office
assigned Meeting equipment/laptop is ready for RPM use at various meetings
and conference room set up - ensuring all the necessary technology is operable
Day-Of meeting support to all attendees including security escort and
conference materials packaging and dissemination
Manager will assist Regulatory Project Managers (RPM) in DRPM draft letters
and correspondence to stakeholders
comments extracted discipline reviews for downloading into the correct
letter template delivered to stakeholders
OTAT QA program with database entries/clean up based on monthly QC reports
received from CBER RIMS.
Clean up and
organize shared drive (N drive)
Bachelors or Associates in a Science related field is preferred. Will consider people who have a HS education and additional years of relevant experience in lieu of a degree.
Must have a minimum of 5 year
of experience in project management, management reporting, task monitoring, or other related experience.
The contractor must be
able to work independently, in a fast paced environment while being able to
execute and follow through to completion of duties assigned.
be proficient in MS Office Suite and be quick learners on varied computer