Senior Manager - Medical Writing - Remote

Overview

The Senior Manager for Medical Writing at Cencora will be responsible for creating technical documentation in compliance with European In Vitro Diagnostics Regulations. This role focuses on improving health outcomes through precise and regulated documentation for medical devices.

In Short

• Prepare technical documentation for IVD medical devices.
• Draft performance evaluation plans and reports.
• Ensure compliance with EU IVDR and other regulations.
• Review clinical performance reports and technical specifications.
• Conduct systematic literature searches.
• Manage clinical studies and documentation.
• Expertise in statistics and cancer diagnostics.
• Strong background in medical writing.
• Collaborate with cross-functional teams.
• Support regulatory submissions and compliance efforts.

Requirements

• Experience in medical writing, especially for IVDs.
• Knowledge of Companion diagnostics.
• Experience with EQA schemes and analysis.
• Strong IVD background, preferably from clinical affairs.
• Experience in immuno histochemistry.
• Expertise in specific therapy areas like cancer diagnostics.
• Ability to manage in-house and external studies.
• Strong attention to detail and organizational skills.
• Excellent communication skills.
• Ability to work independently and collaboratively.

Benefits

• Competitive salary and benefits package.
• Opportunities for professional development.
• Supportive work environment focused on health outcomes.
• Inclusive company culture with equal employment opportunities.
• Flexibility in work arrangements.
• Access to resources for personal and professional growth.
• Commitment to employee well-being and support.
• Global company with diverse opportunities.
• Engagement in meaningful work that impacts lives.
• Collaborative and innovative team atmosphere.