Additional Locations: (n/a)
Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
About the role
The Principal Project Management Analyst provides CAPA stewardship, project support, works to establish better metrics and reporting around Clinical Research CAPA activity, progress and other key aspects that can be translated into preventative actions in support of the clinical organization. This will be done by reviewing requirements and documentation, interfacing with Clinical SMEs and management, facilitating collaborative meetings, and acting as a liaison to bring CAPA related activities to closure.
Your responsibilities will include:
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving clinical quality issues
- Manages implementation of NCEP/CAPA related activities: Develops implementation plan outlining work plans, timelines, roles and resources; Identifies and leads implementation team including cross-divisional/functional representatives; Works with team members to ensure that all supporting infrastructure including program guidelines, processes, training programs, and organizational structure are developed and communicate as needed.
- Develop a process for creating and maintaining connectivity across Divisional and Global clinical CAPAs with the purpose of identification of commonalities and/or signals that could benefit from policy or program improvements
- Acts as an effective leader or team member in supporting various clinical disciplines, decisions, and practices.
- Proactively investigates, identifies, and implements best-in-class Good Clinical Practices in partnership with divisional and functional stakeholders
- Provides CAPA project direction, coaching, and mentoring for teams both within Clinical and as a consultant to divisional and functional teams
- Assures the development and execution of streamlined business systems which effectively identify and resolve clinical quality issues
- Perform Corporate Audit support activities as needed
What we’re looking for in you:
Minimum Qualifications:
- Bachelor’s degree in a related field
- 5 plus years of work experience in Project or Program Management, preferably in Medical Device, Pharma or Healthcare
- 3 plus years of CAPA Analyst or Engineering experience
- Demonstrated strong commitment to compliance, ethics and accountability
- Able to work independently and to solve complex problems
- Process-oriented and experience in process improvement and efficiency initiatives
- Excellent interpersonal, communication and presentation skills
- Strong analytical and critical thinking skills
Preferred Qualifications:
- MBA preferred
- Solid understanding of business acumen and clinical trial fundamentals
- Experience leading transformational initiatives that involve multiple divisions/regions
- Exceptional program management skills, including ability to develop strategy and approach for global efforts as well as the ability to organize, execute and manage multiple priorities.
About us
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 461171
Nearest Major Market: Boston
Job Segment: CAPA, Medical, Project Manager, Engineer, Medical Technology, Management, Healthcare, Technology, Engineering
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