Senior Clinical Medical Writer

Senior Clinical Medical Writer Overview

• The Senior Clinical Medical Writer will analyze and integrate clinical evidence to evaluate product safety and performance.
• Collaborate with cross-functional teams to define clinical evaluation strategies and support regulatory interactions.
• Maintain knowledge of clinical evaluation best practices and evolving regulatory requirements.
• Produce high-quality clinical documentation, ensuring compliance with global regulatory standards.
• Support risk/benefit assessments and address potential data gaps or risks effectively.
• Provide guidance and mentorship to colleagues as needed, fostering a collaborative work environment.
• Utilize literature management tools like ReadCube for efficient evidence integration.
• Work remotely, contributing to a dynamic and innovative clinical research team.

Senior Clinical Medical Writer Key Responsibilities & Duties

• Analyze clinical evidence to evaluate product safety and performance comprehensively.
• Lead clinical evaluations and ensure compliance with global regulatory requirements.
• Collaborate with stakeholders to define and implement clinical evaluation strategies.
• Develop and manage timelines for clinical documentation production.
• Address regulatory feedback and ensure documentation accuracy and clarity.
• Support assessments of risk/benefit and state-of-the-art evaluations.
• Maintain expertise in cardiac rhythm management devices and relevant clinical practices.
• Mentor team members and provide guidance on clinical evaluation processes.

Senior Clinical Medical Writer Job Requirements

• Bachelor’s degree in science with 4+ years of clinical research experience or advanced degree with 2+ years.
• 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 identify and address data gaps or risks effectively.
• Ability to produce high-quality clinical documentation under strict timelines.
• Excellent communication skills for collaboration with cross-functional teams.
• Commitment to maintaining knowledge of clinical evaluation best practices.
• Capability to work remotely and manage responsibilities independently.