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Project Manager Next Generation Sequencing (m/w)
- Project management with start-up spirit
- Prosperous company with dynamic culture
Our client is founded in 2010 and deliver a non-invasive alternative for sensitive real-time molecular diagnostics to improve cancer detection, characterization and treatment.
- Participate in developing an aligned development strategy for each program and ensure that risk mitigation plans are proactively managed
- Drive the agendas and execute governance meetings between internal and external partners
- Monitor and manage project performance metrics/measurements
- Keep senior management team informed of developments and maintain buy-in throughout the partnership process while ensuring that coordination and communication occurs at all stages of the partnership process
- Establish and promote best practices in partnering to gain competitive advantage
- Facilitate Joint Steering Committees (or equivalent bodies) for effective decision making in a timely manner
- Facilitate internal alignment between appropriate parts of the organization to present a unified voice to external partners
- 5+ years experience in managing successful CE-IVD and/or 510K projects at a minimum
- Experience with projects resulting in successful PMA submissions and with flow cytometry projects preferred
- Detailed understanding of CE-IVD and FDA approval processes and requirements for diagnostic assays
- Demonstrated ability to form, lead and develop high-performing teams
- Must demonstrate critical thinking for conflict resolution; risk management; organizational alignment.
- Ability to display credibility and knowledge in front of large and diverse audiences to inspire vision and motivate successful execution
- Strong organizational skills and the ability to handle multiple functions and priorities
- Strong team work skills with global cross-functional teams
- Clear and effective verbal and written communication skills with the ability to communicate effectively with all levels of the organization, and with vendors and partners
- Excellent organization and leadership skills with the ability to effectively motivate and promote continuous improvement and manage projects
- Knowledge of FDA and CE-IVD regulations at a minimum.
- Attractive salary package