Project Manager
Project Manager
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Job Description
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 FDAregulated 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 crossfunctional 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 kickoff meetings status updates and postproject reviews.
- Stay informed about changes in FDA regulations and ensure that project plans reflect these changes.
Qualifications:
- Bachelors degree in Project Management Life Sciences Engineering or a related field.
- Minimum of 8 years of project management experience in FDAregulated industries.
- Proven experience working directly with the FDA on compliancerelated projects.
- Strong understanding of regulatory requirements and quality management systems (e.g. ISOCFR 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.
Preferred Qualifications:
- Masters degree in a relevant field or PMP certification.
- Experience in medical devices pharmaceuticals or biotechnology.
- Familiarity with clinical trial management processes.
Employment Type
Full Time
