Job Title: Regional Project Manager (Americas), Strategic Portfolio Simplification
Duration: 6 Months
Location: San Diego, CA, USA, 92130
Description:
Key responsibilities:
- Project Manager & Scrum Master for one or more R&D teams
- Leads program planning process ensuring requirements are clear and driven by customer need and experience.
- Solidifies and manages project scope, schedule and coordinates with functional leaders to resource projects appropriately and execute to expected results.
- Facilitates identification of project or program risks/issues, develops and assigns responsibility for mitigation/resolution actions; manages mitigation plan.
- Ensures alignment of product value proposition, program scope, and strategic business objectives.
- Provides servant leadership as a Scrum Master to one or more development teams. Leads key technical design and commercial excellence reviews, constructively challenging the team and the organization to rethink assumptions and approach headwinds in new ways
- Actively promotes continuous learning to improve skills of self and the group.
- Ensures cross functional and technical lessons are reviewed, learned, and disseminated.
- Drive alignment with project decision-makers, based on business and technical merits.
- Synthesizes critical information and communicates business implications to stakeholders. Ensures effective communications with the Core Teams using appropriate tools and channels.
- Provides meaningful feedback to functional managers and leaders regarding the performance of Team members for annual performance evaluations.
- Manage end to end one or more projects across departments while influencing project decisions in coordination with Medical Affairs, R&D, Clinical, Regulatory Affairs, Quality, Manufacturing and Logistics timelines.
- Ability to gain cooperation of others and effectively facilitates cross-functional meetings and discussions
- Ensure effective, accurate and timely communication across functional areas
- Serve as a primary point of contact for management regarding progress and goals
- Work with the team leaders to identify and resolve any team and individual performance issues
- Creation and use of project plans for assigned projects, which include clear milestones and assignment of project task responsibilities
- Demonstrate a proactive approach to identify risks to project success; develop effective action plans for resolution
- Appropriately manage / escalate project issues or risks
- Providing leadership and direction for customers and BD project team
Professional Skills & Key Competencies
- Demonstrate Project Management knowledge and competencies
- Demonstrate effective communication skills, verbal and written, with customers, project teams and leadership
- Demonstrate effective SCRUM/Agile/SAFe practices
- Knowledge of Quality Management System (QMS)
- Knowledge of tools like JIRA, Confluence, TeamCenter, Azure DevOps (ADP)
- Passion for disciplined program management, formal program documentation, and transparency
- Strategic thinking
- Focused “results” orientation
- Change management and process improvement
- Highly organized with consistent follow through
Education Qualifications & Previous Experience:
- Bachelor’s degree in a related field. MBA preferred but not required.
- 4+ years of experience in delivering/leading medium size programs in global companies, preferably in healthcare organizations
- 4+ years of experience leading cross-functional teams on complex programs
Desired/Additional Skills & Knowledge:
- Understanding of government-regulated environment (FDA), regulatory submission and product commercialization
- Experience working with Software as Medical Device (SaMD)
- Knowledge and understanding of Medical Device Design controls
- Understanding of Regulatory standards like IEC 62304, IEC 6060-1 etc.
- Experience managing Cloud and SaaS program
- Understanding of documentation processes per IEC 62304
- Experience of working in a functional organization would be a plus but not required
Certifications
- PMI Project Management Professional (PMP) or Scrum Master Certification preferred but not required. Healthcare or medical device/technology industry experience preferred, but not required
