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Location: Onsite
Status Type: Full Time
QUALIFICATIONS
Required:
- Bachelor of Science in Business, Engineering, or Life Science
- Minimum 8 years of experience in a regulated industry, preferably at least 3 years in medical devices, pharmaceuticals, and/or combination products
- Minimum 3 years in commercial operations/sales operations or customer service; experience working directly with ERPs and/or CRMs with a minimum 2 years working with SAP
- Minimum 3 years of experience leading cross-functional, matrixed teams
- Experience directly managing resources, budget, milestones, and/or detailed activities for large-scale projects
- Experience directly managing customers, partnerships, alliances, or external contracts
- Experience in additional functional areas (e.g., supply chain, sales, marketing, manufacturing, or engineering)
- Experience working directly with ISO, FDA, MDD, and/or other healthcare industry regulations and standards
- Proficiency utilizing Microsoft Office suite (Word, Excel, PowerPoint, Project)
Preferred:
- Experience implementing commercial systems and processes at an early-stage enterprise
- Experience in product or process development activities/process
- Experience managing people directly
- Master of Business Administration (MBA) or Master of Science in Engineering/Life Science
- Project Management (e.g., PMP, CAPM, CPMP) Certification
Skills & Competencies:
- Leads cross-functional team, including driving accountability and responsibility for results and forward progress
- Collaborates effectively with diverse stakeholders; demonstrates partner commitment and customer orientation
- Communicates effectively in writing, including ability to write in a clear, concise, logical, and grammatically correct manner
- Seeks to understand when listening to others; demonstrates awareness of what is requested; communicates orally in a professional manner that inspires confidence
- Exercises discernment in dissemination of information and sense of urgency; escalates issues to ensure timely and relevant responses; demonstrates ability to handle sensitive information with discretion and tact
- Demonstrates high attention to detail; fosters a culture of excellence in partner deliverables
- Distills complicated topics for intended audience; facilitates large discussions, and adjusts/adapts/responds to real-time feedback
- Leads and executes strategic plans and workstreams, including planning, organizing, securing, and managing resources to achieve goals
- Solves problems, including providing clarity in defining problem statements in ambiguous, complex situations; draws logical conclusions
- Sets clear goals, delegates effectively, and leverages the skills and expertise of others
- Influences without direct authority and negotiates conflict; maintains rational and objective demeanor when faced with stressful situations
Physical Requirements:
- Ability to remain in stationary position for extended periods of time
- Ability to consistently operate a computer, and other office equipment (e.g., printer, telephone, etc.)
- Ability to work in an open office environment, on-site at an Enable location
RESPONSIBILITIES:
- Create a vision and roadmap for the foundational commercial systems (tools, reporting, dashboards) to support launch readiness; streamline commercial operations processes and ensure alignment with regulatory and quality requirements specific to combination products
- Coordinate and partner with program management, supply chain, manufacturing, and engineering to operationalize the commercial readiness roadmap
- Lead internal JMST (joint manufacturing supply team)
- Lead partner-facing JMSTs (joint manufacturing supply team)
- Develop and document standard operating procedures (SOPs) for commercial workflows, ensuring scalability and compliance
- Implement best practices on programs; ensure consistency and thoroughness of deliverables
- Develop, maintain, and nurture positive relationships with key stakeholders at pharmaceutical partners; inspire confidence with pharma partners
- Develop, maintain, and nurture positive relationships with internal colleagues; demonstrate high level of interpersonal skills in interactions; work independently with limited oversight
- Leverage team skills and experience to achieve program/project goals; communicate clear expectations to team members in order to meet deadlines
- Identify business and process issues; model a culture of quality and continuous improvement
- Maintain awareness of new and changing processes in commercial operations; identify potential risks for pharmaceutical partners; implement necessary changes to maintain compliance
- Model teamwork, diversity, and inclusion within team, between teams and other groups
- Operate effectively in a dynamic start-up environment; be willing to do tasks outside of immediate responsibilities to contribute to overall team success
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