General Summary: This role will oversee all aspects of assigned project(s) and are responsible for the coordination, performance and completion of those projects.
The incumbent will have primary responsibility for
- Agency Announcement and Centers for Regulatory Science and Innovation Program, and Grants program including:
- Gathering quad charts, whitepapers, and full proposals for review by internal FDA experts
- Contacting potential reviewers (identified by the Associate Director for Research Strategy and Partnerships) and their supervisors to request concurrence.
- Organizing and compiling all reviews received to inform OCE leadership to determine which proposals to fund.
- Overseeing updates and changes to any future grants management solutions
- Coordinating all human subject determination submissions for internal and extramural research projects, including:
- Requesting relevant documents from external and internal investigators, including protocols, technology transfer agreements, Internal Review Board letters and supporting document, principal investigator credentials and training.
- Developing drafts for each submission to the Office of the Chief Scientist including overviews of the research study, roles and responsibilities of the FDA and external partners, and proposed determination for review by FDA human liaisons.
- Scientific management of extramural research projects funded by OCE.
- Developing and maintaining MS Teams and/or SharePoint sites with all relevant scientific and technical documents.
- Developing agendas for regular research meetings.
- Coordinating with members of the research team on action items and deliverables for each project.
- Manage, coordinate, assist with Intramural Research Projects.
- Ensuring that research project entries to the OCE tracking system are accurate and up to date.
Education Requirement: Bachelor’s Degree or equivalent experience.
Experience Requirement: Minimum of five (12) years of experience in project management.
Other Requirement(s): This position requires U.S. Citizenship or a Green Card holder and the ability to obtain and maintain a Government public trust level security clearance. For a candidate that is a Green Card holder, they must have lived in the United States for at least three out of the past five years prior to your application date. You will also meet the residency qualifications if you lived abroad while on government or military duty or if you were a dependent of a federal employee of military member.
Performance Requirements:
- Exceptional verbal and written communication skills.
- Excellent interpersonal and customer service skills.
- Excellent problem-solving skills with ability to analyze situations, identify existing or potential problems and recommend solutions.
- Excellent time-management skills with a proven ability to meet deadlines.
- Exercises discretion and good judgement in all things, especially regarding sensitive or confidential matters
- Extremely proficient in Microsoft Office Suite
- Exceptional organizational skills and attention to detail.
- Ability to function well in a high-paced and at times stressful environment.
- Ability to work independently as well as collaboratively.
- Ability to establish and maintain effective and positive working relationships with all staff and visitors.
Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.
Work Environment: Work performed in an office environment. Involves frequent contact with staff and customers.
Mental/Physical Requirements: Manual dexterity for office machine operation; stooping, bending to handle files and supplies, mobility to complete errands or deliveries. Must be able to remain in stationary position for extended periods of time. Stress can be triggered by multiple demands and deadlines.
DISCLAIMER: The above statements are intended to describe the general nature and level of work performed. They are not intended to be an exhaustive list of all responsibilities, duties, skills, efforts, requirements, or working conditions. Management reserves the right to revise the job or to require that other or different tasks be performed as assigned in accordance with business demands and/or contractual requirements.
Diversity, Inclusion, & Engagement at Brillient:
At Brillient, we not only accept difference, but we also promote it, we embrace it, and we thrive on it for the betterment of our patients, our employees, and our culture.
We are proud to be an equal opportunity workplace and an affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status or any other status protected under applicable law.
