Senior Functional Specialist

• Define project scope phases deliverables milestones timelines and measures of success.
• Develop and maintain project plans trackers schedules and support documentation.
• Monitor assignments action items dependencies and deadlines across active projects.
• Identify emerging issues and coordinate follow-up to support timely completion of FDA commitments.
• Compile monthly status updates on project progress accomplishments risks and upcoming activities.

• Conduct literature reviews environmental scans and data analyses to support ongoing initiatives.
• Retrieve review curate and organize records from FDA systems and other relevant sources.
• Contribute to the development of Federal Register notices presentations speeches articles reports and related communications.
• Draft revise format route and track documents through internal review and clearance.
• Prepare briefing materials summaries and other written products for leadership and project teams.

• Support the development of stakeholder engagement and outreach strategies.
• Coordinate internal and external meetings including participant outreach agendas briefing materials logistics and follow-up.
• Document key discussion points decisions recommendations and next steps.
• Support public meetings and workshops through notice development speaker coordination registration logistics and on-site or virtual assistance.
• Arrange meeting platforms and technology for FDA and stakeholder engagements

• Develop and maintain digital tools trackers and workflows for monitoring projects and deliverables.
• Build and manage databases or data repositories needed to support project activities.
• Maintain SharePoint sites project files reference materials and final records.
• Organize and archive meeting summaries cleared documents and supporting materials.
• Improve project processes and tools to strengthen coordination reporting and information management.

• Respond to staff inquiries and project-related requests in a timely manner.
• Coordinate across project teams to gather updates resolve information gaps and support completion of deliverables.
• Provide day-to-day operational support for high-priority and time-sensitive initiatives

• 5 years of experience supporting the FDA and/or industry

• PMP Certification

• PharmD required

DRT Strategies Inc. (DRT) follows the guidelines outlined by the Equal Employment Opportunity Commission (EEOC) to provide all employees and qualified applicants employment without regard to race color religion sex (including pregnancy childbirth or related conditions transgender status and sexual orientation) national origin age genetic information disability protected veteran status or any other protected characteristic under federal state or local law.

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