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:
- Plan, schedule and coordinate key stakeholder meetings and the conferences
- Plan and prepare submitted meeting packages and distribute to the review team
- Assist in the review of received packages and disposition appropriately to the correct data storage location.
- Support meeting attendees and navigate proper clearance via FDA Security Office
- Ensure assigned Meeting equipment/laptop is ready for RPM use at various meetings and conference room set up -
ensuring all the necessary technology is operable
- Provide Day-Of meeting support to all attendees including security escort and conference materials packaging and
- Project Manager will assist Regulatory Project Managers (RPM) in DRPM draft letters and correspondence to
- Document comments extracted discipline reviews for downloading into the correct letter template delivered to
- Help the 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)
- Other duties as assigned
- Bachelors or Associates in a Science related field is preferred. Will consider people who have a HS education and an additional 4 years of experience in lieu of a degree.
- Must have a minimum of 3 years of experience in project management, management reporting, task monitoring, or other
- 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.
- Must be proficient in MS Office Suite and be quick learners on varied computer software
- Must be able to obtain a Public Trust Clearance
SAIC is a premier technology integrator solving our nation's modernization and readiness challenges. Our offerings across defense, space, civilian, and intelligence markets include high-end solutions in engineering, IT, and mission outcomes. We integrate the best components from our portfolio with our partner's ecosystem to deliver innovative and effective solutions. We are 25,500 strong; driven by mission, united by purpose, and inspired by opportunities. Headquartered in Reston, VA, SAIC has annual revenues of nearly $7.1 billion. For information, visit saic.com or Working at SAIC for benefits details.
SAIC is an Equal Opportunity Employer empowering people no matter their race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or veteran status. We strive to create a diverse, inclusive and respectful work culture that values all.