Project Manager

4 days ago

Silver Spring, Maryland, United States Puente de Vida LLC Full time
Job Summary

Puente de Vida LLC is seeking an experienced Project Manager to lead our regulatory document operations team. As a key member of our organization, you will be responsible for managing all program-related activities, overseeing a team of professionals, and ensuring exceptional customer satisfaction.

Key Responsibilities
  • Program Management: Manage the overall activities performed under the Task Order (TO) and ensure work products, services, and deliverables are timely, complete, and accurate.
  • Resource Allocation: Shift resources, as needed, to support optimal services and ensure the team is equipped to meet client needs.
  • Client Communication: Serve as the primary point of contact for all matters and issues related to the TO, ensuring effective communication and issue resolution.
  • Issue Escalation: Escalate issues to FDA and ensure challenges and problems are resolved promptly, maintaining a high level of customer satisfaction.
  • Team Development: Support hiring and onboarding of new staff, ensuring a smooth transition and effective integration into the team.
  • Reporting and Analysis: Gather data and statistics, compile monthly reports, and provide insights to inform business decisions.
  • Meetings and Feedback: Attend meetings, ensure feedback from FDA is communicated effectively to all staff, and maintain open lines of communication.
Requirements
  • Education and Experience: Bachelor's degree in health, Business Administration, Public Administration, Records Information Management, or a related business field, and six years of professional and relevant Project Management experience, managing a team of 6 or more staff.
  • Certifications and Skills: PMP certification a plus, with knowledge of contemporary project management tools and a command of the core principles of effective management, including effective delegation, ownership, responsibility development, and tracking.
  • Regulatory Knowledge: Must have demonstrated ability to plan, integrate, and manage life cycle regulatory document operations involving document processing in high volume automated and manual operations and scientific data abstraction operations.
  • Communication and Compliance: Must have the ability to effectively communicate with Federal COR's, management, user organizations, and technical staff, ensuring compliance with FDA records management requirements.
  • Eligibility and Clearance: Must be eligible to work in the US and able to obtain a clearance.
  • Work Schedule: Monday - Friday, 7:00 - 5:30 pm/Flexible.

Puente de Vida LLC is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We offer a competitive compensation package including a competitive salary, medical benefits, PTO, holiday pay, and more.

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