Manager, Medical Writing

As the Manager, Medical Writing you will support clinical evaluation and regulatory documentation across a diverse endoscopy portfolio. In this role, you will lead a distributed team, oversee end-to-end medical writing deliverables, and contribute scientific expertise throughout the product lifecycle. The position interfaces closely with clinical, regulatory, quality, and commercial teams to ensure compliant, high-quality outputs across regions.

What You Will Do

• Lead and manage a global team of medical writers, including hiring, onboarding, performance management, and development against defined performance metrics

• Oversee delivery of clinical evaluation documents, including protocols, reports, literature reviews, and post-market documentation, ensuring on-time completion and regulatory compliance

• Plan and allocate resources to meet project timelines, tracking key performance indicators for quality, timeliness, and productivity

• Direct development of clinical study protocols, clinical study reports, manuscripts, and scientific publications in alignment with clinical and regulatory requirements

• Apply regulatory standards (ISO, FDA, international regulations) to writing strategies and documentation across product development stages

• Establish and maintain standardized processes, templates, and tools to improve efficiency, consistency, and audit readiness

• Partner with cross-functional stakeholders to align priorities, support product development, and ensure accuracy of clinical and promotional claims

• Manage budgets, forecasts, and operational metrics, and implement process improvements including automation and standardization initiatives

What You Need

Required

• Bachelor’s degree in life sciences, biology, biomedical engineering, nursing, or related discipline

• Minimum 8 years of experience in medical writing, clinical research, or related field

• Minimum 2 years of people management experience or leadership of critical projects

• Demonstrated experience authoring regulatory and clinical evaluation documents (e.g., clinical evaluation reports, study reports, literature summaries)

Preferred

• Advanced degree (Master’s or higher) in a relevant field

• Certification in clinical research or project management

• Minimum 2 years of experience in the medical device industry or pharmaceutical industry

• Experience applying global regulatory requirements, including ISO, FDA, and international regulations