Project Manager

Position: Project Manager – Healthcare / FDA

Location: Rockville MD,USA
Employment Type: Full-Time 
Industry: Healthcare / Life Sciences / Federal

Position Overview

We are seeking an experienced Project Manager with strong healthcare industry and FDA experience to lead and manage complex technology and business projects. The ideal candidate will have a proven track record of managing projects in regulated healthcare or life sciences environments, with a strong understanding of FDA regulations, compliance requirements, quality processes, and federal project environments.

The Project Manager will be responsible for planning, executing, monitoring, and successfully delivering projects while coordinating cross-functional teams, stakeholders, vendors, and leadership.

Key Responsibilities

• Lead projects from initiation through planning, execution, monitoring, and closure.
• Develop and maintain comprehensive project plans, schedules, milestones, deliverables, and resource plans.
• Manage project scope, timelines, budgets, risks, issues, dependencies, and change requests.
• Coordinate cross-functional teams including business, technical, quality, regulatory, clinical, and compliance stakeholders.
• Work closely with healthcare and FDA stakeholders to ensure project deliverables meet applicable regulatory and organizational requirements.
• Ensure projects comply with applicable FDA regulations, policies, standards, and quality requirements.
• Support projects involving FDA-regulated systems, applications, data, processes, or documentation.
• Maintain project documentation, status reports, meeting minutes, action items, RAID logs, and executive dashboards.
• Identify project risks and develop mitigation and contingency plans.
• Facilitate project meetings, stakeholder discussions, steering committee meetings, and status reviews.
• Track project progress against approved schedules, budgets, scope, and quality objectives.
• Communicate project status, risks, issues, and dependencies to senior management and stakeholders.
• Manage vendors, contractors, and third-party partners as required.
• Coordinate User Acceptance Testing (UAT), implementation, deployment, and transition activities.
• Ensure appropriate documentation and approvals are completed throughout the project lifecycle.
• Support audit and inspection readiness activities, including preparation and maintenance of required project documentation.
• Drive issue resolution and escalate critical risks or decisions when necessary.
• Ensure project deliverables are completed on time and meet quality and compliance expectations.
• Apply Agile, Waterfall, or hybrid project management methodologies based on project requirements.

Healthcare Experience

The candidate should have experience working on projects within healthcare, life sciences, pharmaceutical, medical device, public health, or other regulated environments.

Experience with one or more of the following is preferred:

• Healthcare IT systems and applications
• Data Standards experience in FHIR, CDISC, SEND, ADAM
• Clinical or patient-related systems
• Healthcare data and analytics
• Healthcare interoperability
• Public health programs
• Clinical research systems
• Pharmaceutical or medical device projects
• Healthcare regulatory and compliance initiatives

FDA Experience

Strong experience working with FDA-regulated environments is required. Candidates should have experience supporting projects involving areas such as:

• FDA regulatory requirements and compliance
• FDA-regulated applications, systems, or processes
• Regulatory documentation and submissions
• Quality Management Systems (QMS)
• Computer System Validation (CSV)
• 21 CFR Part 11
• Good Manufacturing Practices (GMP)
• Good Clinical Practice (Google Cloud Platform)
• FDA audits, inspections, or regulatory readiness
• Validation and compliance documentation
• Change control and deviation management
• CAPA and corrective/preventive action processes

Required Qualifications

• Bachelor's degree in Computer Science, Information Technology, Healthcare Administration, Business Administration, or a related field.
• 8+ years of project management experience, preferably in healthcare, life sciences, pharmaceutical, medical device, or federal environments.
• Demonstrated experience managing complex, cross-functional projects.
• Hands-on experience working in an FDA-regulated environment.
• Understading of clinical data standards like FHIR, CDISC, SEND, ADAM.
• Strong understanding of healthcare processes, regulatory requirements, and compliance.
• Experience with project management methodologies such as Agile, Scrum, Waterfall, or hybrid methodologies.
• Strong knowledge of project planning, risk management, issue management, change management, and stakeholder management.
• Excellent written and verbal communication skills.
• Strong leadership, organizational, analytical, and problem-solving skills.
• Ability to manage multiple priorities and projects in a fast-paced, regulated environment.

Preferred Qualifications

• PMP certification.
• Certified ScrumMaster (CSM), PMI-ACP, or similar certification.
• Experience supporting FDA, HHS, NIH, or other federal healthcare agencies.
• Experience with federal government projects and contracting environments.
• Experience with Microsoft Project, Jira, Confluence, Smartsheet, or similar project management tools.
• Knowledge of HIPAA, HITECH, FISMA, NIST, and other applicable healthcare/federal compliance frameworks.
• Experience with system implementation, modernization, integration, or data migration projects.
• Experience preparing executive-level project status reports and presentations.

Key Skills

Project Management | Healthcare IT | FDA Compliance | Regulatory Affairs | Risk Management | Stakeholder Management | Agile | Scrum | Waterfall | Quality Management | Computer System Validation | 21 CFR Part 11 | HIPAA | Federal Healthcare | Vendor Management | Change Management | UAT | Project Planning | Executive Reporting

Soft Skills

• Excellent communication and presentation skills
• Strong leadership and team-building abilities
• Ability to work effectively with technical and non-technical stakeholders
• Strong attention to detail
• Excellent organizational and time-management skills
• Ability to manage competing priorities
• Strong decision-making and problem-solving capabilities
• Ability to work effectively in highly regulated environments