We are seeking an experienced Project Manager to lead multiple cross-functional projects supporting Companion Diagnostic (CDx) initiatives within a regulated medical device and biotechnology environment. This role will manage projects throughout the full lifecycle, partnering with internal stakeholders and external collaborators to ensure projects are delivered on time, within scope, and within budget while maintaining compliance with industry regulations and quality standards.
Responsibilities
- Manage multiple projects simultaneously through the complete project lifecycle, from planning through execution and completion.
- Define project scope, develop project charters, timelines, budgets, and resource plans to ensure successful project delivery.
- Lead cross-functional teams, including domestic and international stakeholders, to achieve project milestones and deliverables.
- Monitor project schedules, budgets, risks, and documentation, proactively identifying issues and implementing mitigation strategies.
- Facilitate collaboration with external partners supporting Companion Diagnostic (CDx) programs.
- Prepare and present project updates, budget analyses, and status reports for senior leadership using advanced Excel and Power BI.
- Track project performance, manage budget variances, and recommend contingency plans when necessary.
- Foster an effective team environment that promotes collaboration, accountability, and successful project execution.
- Ensure projects are executed in accordance with applicable medical device regulations, quality standards, and organizational processes.
Qualifications
- Bachelor's degree in a scientific, engineering, business, or related field.
- Minimum of 5 years of project management experience within the medical device, biotechnology, or pharmaceutical industry.
- Experience managing multiple cross-functional projects in a regulated environment.
- Knowledge of medical device regulations, FDA requirements, GMP, and quality management systems.
- Experience supporting Companion Diagnostic (CDx) programs or related diagnostic or medical device initiatives is preferred.
- Strong proficiency with Microsoft Excel and Power BI for project tracking, reporting, and data analysis.
- Demonstrated ability to manage project scope, schedules, budgets, risks, and stakeholder