Luke Baker

• Lead a global team of 20+ medical writers, ensuring the delivery of high-quality, MDR-compliant regulatory documents across multiple device portfolios.
• Manage relationships with 10+ client organizations to help achieve regulatory compliance in multiple geographies.
• Develop and execute business development strategies, expanding service offerings and strengthening client partnerships.
• Oversee performance management, career development, and resource allocation for a multi-level writing team, fostering growth and retention.
• Partner with the executive leadership team to provide cross-functional support, communicate progress, and drive strategic initiatives through collaborative brainstorming.

• Managed team of 6 direct reports, delivering over 20 CERs, CEPs, and PMCF Reports annually with high compliance standards.
• Directed project scoping exercises to establish accurate timelines and requirements.
• Served as primary client interface through weekly check-ins, fostering strong relationships and addressing concerns.
• Drafted estimates and Statements of Work for new client engagements, facilitating business development.
• Provided career guidance, performance feedback, and mentoring to enhance professional growth and retention.

• Managed multiple projects with overlapping timelines across several writers.
• Facilitated communication between writers and client managers to update project progress and ensure timely, high-quality deliverables.
• Strategized regulatory pathways for class IIa and class III medical devices.
• Cultivated strong relationships with direct reports to enhance job satisfaction and performance.
• Delivered constructive verbal and written feedback to direct reports for continuous improvement.
• Fostered a cohesive team environment centered on trust and open communication.

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