Senior Clinical Medical Writer

Overview

• Collaborate with cross-functional teams to develop clinical evaluation strategies and ensure compliance with global regulatory requirements.
• Analyze and integrate diverse clinical evidence to evaluate product safety and performance effectively.
• Maintain up-to-date knowledge of clinical evaluation best practices and regulatory landscapes.
• Produce high-quality clinical documentation, including Clinical Evaluation Reports (CERs).
• Support risk/benefit assessments and state-of-the-art evaluations for medical devices.
• Manage document timelines and address regulatory feedback effectively.
• Provide guidance and mentoring to colleagues on clinical evaluation processes.
• Work on-site four days a week, with potential for contract extension or permanent conversion.

Key Responsibilities & Duties

• Lead clinical evaluations to support product safety and performance assessments.
• Develop and manage Clinical Evaluation Reports (CERs) in compliance with regulatory standards.
• Utilize literature management tools, such as ReadCube, for evidence analysis.
• Collaborate with stakeholders to define clinical evaluation strategies and regulatory interactions.
• Address regulatory feedback and ensure timely completion of documentation.
• Support assessments of risk/benefit and state-of-the-art practices for cardiac rhythm management devices.
• Mentor colleagues and provide guidance on clinical evaluation processes.
• Ensure adherence to evolving clinical and regulatory landscapes.

Job Requirements

• Bachelor’s degree in science with 4+ years or advanced degree with 2+ years in clinical research or evaluation.
• Proven experience in Clinical Evaluation Report (CER) writing and regulatory compliance.
• Familiarity with cardiac rhythm management devices and literature management tools like ReadCube.
• Strong analytical skills to integrate clinical evidence and evaluate product safety.
• Ability to manage document timelines and address regulatory feedback effectively.
• Excellent communication skills for producing high-quality clinical documentation.
• Knowledge of global regulatory requirements and clinical evaluation best practices.
• Flexibility to work on-site four days a week with potential for permanent conversion.