What are the responsibilities and job description for the Project Manager position at Trigent Solutions Inc.?
Title: Project Manager
Duration: Full Time Permanent
Client: FDA
Location: 100% Remote
Job Summary
We are seeking an experienced Project Manager with a solid background in FDA-regulated environments. The ideal candidate will be responsible for leading projects from initiation to completion, ensuring compliance with regulatory standards while delivering quality results on time and within budget. If you have a passion for project management and a proven track record of working with the FDA, we want to hear from you!
Key Responsibilities
Duration: Full Time Permanent
Client: FDA
Location: 100% Remote
Job Summary
We are seeking an experienced Project Manager with a solid background in FDA-regulated environments. The ideal candidate will be responsible for leading projects from initiation to completion, ensuring compliance with regulatory standards while delivering quality results on time and within budget. If you have a passion for project management and a proven track record of working with the FDA, we want to hear from you!
Key Responsibilities
- Lead and manage projects related to FDA compliance, ensuring adherence to regulatory requirements and timelines.
- Develop project plans, schedules, and budgets; monitor progress and adjust plans as necessary.
- Coordinate cross-functional teams, including engineering, regulatory, quality assurance, and clinical affairs, to achieve project objectives.
- Communicate project status to stakeholders, providing regular updates and managing expectations.
- Conduct risk assessments and develop mitigation strategies to address potential project challenges.
- Ensure all project documentation meets FDA standards and is completed accurately and on time.
- Facilitate project meetings, including kick-off meetings, status updates, and post-project reviews.
- Stay informed about changes in FDA regulations and ensure that project plans reflect these changes.
- Bachelor’s degree in Project Management, Life Sciences, Engineering, or a related field.
- Minimum of 8 years of project management experience in FDA-regulated industries.
- Proven experience working directly with the FDA on compliance-related projects.
- Strong understanding of regulatory requirements and quality management systems (e.g., ISO 13485, 21 CFR Part 820).
- Proficient in project management software and methodologies (e.g., Agile, Waterfall).
- Excellent organizational and multitasking skills, with a keen attention to detail.
- Strong leadership and team management abilities.
- Excellent communication and interpersonal skills.
- Master’s degree in a relevant field or PMP certification.
- Experience in medical devices, pharmaceuticals, or biotechnology.
- Familiarity with clinical trial management processes.
