⚡Senior Project Manager
🌎 Remote
💲120,000 – 130,000
 
Interested in joining an innovative healthtech company focused on the colabouration between the U.S Food and Drug Administration (FDA) and the Medical Device Innovation Consortium (MDIC)?
 
This is an exciting opportunity to work with leadership as a senior project manager in a fast paced environment focusing on the use of RWD and RWE to support the evaluation and monitoring of medical devices.

👨‍💻 Key Responsibilities:

• Define project scope, tasks, resource requirements, and deliverables in collaboration with the appropriate team members, Partners, and Sponsors.
• Create and maintain comprehensive project documentation for projects (e.g., detailed project plans, communication plan, risk management plan, decision logs, etc.)
• Collaborate with the project team members to track project tasks, milestones and action items.
• Ensure that project commitments are fulfilled, and deadlines are met through follow-up activities.
• Proactively work with project stakeholders to identify and monitor project risks.
• Create and execute risk mitigation strategies and solutions for issues in collaboration with the appropriate internal and external stakeholders including executive leadership and project team (e.g., Sponsor, Partner, VP of Sponsor Relations, VP of Partnerships Management, Sr. Director of Evidence Generation).
• Draft and oversee the review of all project-related communications and ensure timely distribution to the appropriate stakeholders.
• Present technical project information including project status and issues to leadership and project stakeholders.
• Assist in the development of KPIs and associated progress reports.
• Organize, conduct, and facilitate meetings with external partners and stakeholders.
• Mentor junior project managers.
• Contribute to the organization’s overall growth by assuming additional responsibilities that are not included in the aforementioned general responsibilities.
• Occasional travel onsite or client site for meetings required (<25%)

 
👩‍🎓 Qualifications & Requirements:

• Bachelor’s degree in health, engineering, or science such as biomedical engineering, medical engineering, biotechnology, public health, quality assurance (QA), or regulatory affairs required
• Project Management Professional (PMP) certification or master’s in project management required
• Master of Science/Arts/Public Health/Business Administration degree preferred
• 7+ years of project management experience, specifically 2+ years as a Senior Project Manager
• Professional experience in medtech, life science, health care, and/or clinical research (private or nonprofit sector), with medical device and/or diagnostics experience strongly preferred.
• Direct experience with various Real-World Data sources (e.g., electronic health records (EHR), registries, patient-generated health data, public and private claims) and study designs used for medical devices and diagnostics strongly preferred
•  Understanding of regulatory processes related to medical devices and experience directly supporting a regulatory filing preferred
• Hands-on experience with using videoconferencing and filesharing tools such MS Teams, web-based project management tools like Smartsheet, Asana, and/or or Wrike, and MS Office 365 products
• Ability to rapidly adapt to new collaborative technologies as they become available
• Excellent verbal and written communication skills, with the ability to write succinctly and quickly
• Success managing immediate, short-term, and long-term projects simultaneously in a fast-paced environment
• Skilled in interacting with a diverse range of stakeholders, including internal and external executives, epidemiologists, data engineers, and third-party vendors, at differing levels 
• Ability to maintain strict confidentially, discretion, and judgment in dealing with confidential, sensitive, and controversial issues in all aspects of work
• Ability to be flexible and work collaboratively as a team within a dynamic work environment that includes remote environment

⭐ Competencies:

• Accountability for Results: focus on key strategic objectives; accountable for high standards of performance.
• Strategic Thinking & Problem Solving: Make decisions considering the long-term impact on customers, employees, and business
• Patient & Customer Centricity: Maintain an ongoing focus on customer and stakeholder needs, communicating effectively
• Impactful Communication: Communicate with logic, clarity, and respect to achieve the best results
• Respectful Collaboration: Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals
• Empowered Development: Play an active role in professional development as a business imperative

 
⭐ Benefits

• Interesting and meaningful work
• 401k
• Comprehensive benefits
• Generous parental leave
• Training and career progression opportunities