Project Manager & Scrum Master - PMO -[FDA, Healthcare,PMP or Scrum Certification mandatory]

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
• 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
• Able 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
• Create 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
• Provide leadership and direction for customers and client 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
• Experience managing Cloud and SaaS program
• Experience of working in a functional organization would be a plus but not required