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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive project management expertise, including risk management, change management, and strategic planning within the context of in vitro diagnostic product development. Proficient in leading cross-functional teams and managing large-scale projects while adhering to ISO 13485 standards and 21 CFR 820 regulations.
Highest-signal resume keywords
Project Management ExperienceRisk ManagementISO 13485 ComplianceMicrosoft Office ProficiencyPMI Certification
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project ManagementData AnalysisBudget DevelopmentSchedule DevelopmentRisk Management PlanningChange ManagementStrategic PlanningIn Vitro Diagnostic Product DevelopmentDesign Control ProcessesMetrics Tracking
Soft Skills
LeadershipCoachingNegotiationConflict MitigationCommunication Skills
Tools & Technologies
Project Management SoftwareMicrosoft ProjectMicrosoft VisioMicrosoft ExcelMicrosoft PowerPointSmartsheet
Certifications & Qualifications
Project Management Institute (PMI) Certification
Industry Keywords
Molecular BiologyBiochemistryEngineeringQuality Management SystemMatrix ManagementBiological Systems IntegrationAutomation21 CFR 820 RegulationsISO 13485 Standards
About the role
Key responsibilities & impact- Organize and execute programs supporting the product development pipeline
- Lead programs toward successful completion with project/program management rigor and consistency
- Lead and coach multiple efforts and teams
- Apply project management methodologies and best practices
- Define strategy and requirements with business stakeholders
- Develop schedules, budgets, and risk management plans
- Maintain program metrics and communicate progress to key stakeholders
- Make critical decisions using data analysis, experience, and judgment
- Formulate, organize, and monitor interconnected projects and cross-project activities
- Develop and mentor program and project team members
- Influence, negotiate, mitigate conflict, and build relationships
- Partner with cross-functional teams while managing multiple projects simultaneously
- Facilitate objectives, key performance indicators, and results tracking
- Collaborate with management to escalate staffing issues and critical risks
- Support and comply with company Quality Management System policies and procedures
- Uphold company mission and values
Requirements
What you’ll need- Bachelor’s Degree in Molecular Biology, Biochemistry, Engineering, or related field
- 8+ years of broad-based project management experience, including tracking and reporting for a large project portfolio
- 5+ years managing and leading large-impact, large-budget, high-risk, and critical projects
- 5+ years using Project Management software
- 3+ years managing design control processes compliant with ISO 13485 standards and 21 CFR 820 regulations
- Demonstrated success in risk management, change management, and strategic planning
- Demonstrated ability to manage the in vitro diagnostic product development process
- Demonstrated ability to balance cost, quality, and schedule constraints while escalating issues
- Advanced proficiency with Microsoft Office, including Project, Visio, Excel, and PowerPoint
- Authorization to work in the United States without sponsorship
- Ability to perform essential duties with or without accommodation
- Preferred: Advanced Degree in Molecular Biology, Biochemistry, Engineering, or related field
- Preferred: Experience in matrix management organizations
- Preferred: Experience integrating biological systems with automation and software applications
- Preferred: Project Management Institute (PMI) certification
- Preferred: Experience with Smartsheet
- Strong oral and written communication and presentation skills
- Ability to prioritize and balance multiple competing priorities
- Ability to work in a matrix management organization
- Ability to travel 10% of working time, potentially including overnight/weekend travel
- Ability and means to travel between local Exact Sciences locations
Benefits
Comp & perks- Career development with an international company
- Free medical coverage eligibility through the Health Investment Plan (HIP) PPO medical plan
- Excellent retirement savings plan with a high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit toward a bachelor’s degree
- Health and wellness benefits
- Equal Opportunity Employer committed to employee diversity