Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represent ground breaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Job Summary and Responsibilities:
• Develop and implement lifecycle management processes
• Lead cross-functional product development teams from inception through completion on complex, substantial projects that are strategic to the business
• Independently develop and implement project plan, timeline, budget, and performance metrics
• Track project progress, evaluate project risks, develop risk mitigation and contingency plans
• Organize and maintain records of team meetings
• Maintain proper documentation per product development process
• Serve as internal focal point for critical project information and communicate project status updates to immediate supervisor, senior management and other stakeholders
• Facilitate discussions on project issues and implement resolutions
Knowledge and Skills:
• Direct responsibility in leading global cross-functional product development team for medical devices (project budget >$2M) with minimal supervision
• Demonstrated ability to adhere to project timeline and stay within budget
• Demonstrated ability to establish and maintain effective working relationships across functions with key stakeholders
• Demonstrated ability to anticipate and facilitate discussions on complex issues
• Experience in design control process
• Demonstrated proficiency in project management tools - create project plan, develop budget, track performance metrics
• Working knowledge of US and international regulatory requirements as well as good clinical and manufacturing practices
Basic Qualifications:
BS in life science, physical science or engineering with 10+ years of product development experience in medical device or biotech industry; 7+ years of direct project management experience in a medium- to large-size company (200+ employees) OR MS in life science, physical science or engineering with 7+ years of product development experience in medical device industry; 5+ years of direct project management experience in a medium- to large-size company (200+ employees); Experience in managing and leading global cross-functional product development teams; Experience in managing product development projects involving human clinical studies
Preferred Qualifications:
MBA degree and Experience in direct management of a human clinical study, relevant experience may include protocol generation, study preparation, study monitoring, data management and publication of clinical study report
Please apply online at: www.Genzyme.com/careers job number 31696